Mediterranean DietENERGY2MOBNCT06988904
ENERGY2MOB STUDY: OBESITY MANAGEMENT IN BERGUEDÀ
A study testing Energy2MOB in people with Mediterranean Diet and Overweight or Obese Adults, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Background: Obesity is a prevalent multifactorial disease worldwide and has become a significant public health concern. The latest data from the 2022 Catalonia Health Survey show that 56.2% of men and 43.7% of women are overweight or obese, and 39% of children aged 6 to 12 years have excess weight. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mediterranean Diet, Overweight or Obese Adults, Exercise Therapy
- What is being tested?
- Energy2MOB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jun 2025to 7 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Overweight (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²)
- Availability to attend at least 80% (6 out of 8) of the group sessions
Who cannot join
- Significant language barriers (unable to communicate in Catalan or Spanish)
- Previous bariatric surgery
- Moderate to severe cognitive impairment
- Severe psychiatric disorders preventing participation in group sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Unitat de Suport a la Recerca de la Catalunya Central, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Manresa, Spain, Manresa, Barcelona 08242
Manresa, Barcelona, 08242
Mar Gargallo Civil, +34 660274434
Anna Ruiz Comellas, +34626999007, annaruizcom@gmail.com
About this study
Official title: EFFECTIVENESS OF THE GROUP-BASED NUTRITION EDUCATION PROGRAMME FOR OBESITY MANAGEMENT IN BERGUEDÀ: A RANDOMISED CLINICAL TRIAL. ENERGY2MOB STUDY
Background: Obesity is a prevalent multifactorial disease worldwide and has become a significant public health concern. The latest data from the 2022 Catalonia Health Survey show that 56.2% of men and 43.7% of women are overweight or obese, and 39% of children aged 6 to 12 years have excess weight. Excess adiposity poses a health risk as it is associated with various chronic diseases such as type 2 diabetes mellitus, hypertension, and dyslipidaemia, all of which affect quality of life and increase mortality risk.
Hypothesis: The Energy2MOB obesity management programme in Berguedà is a group-based intervention incorporating nutrition education and physical activity. It aims to reduce excess body weight and the risk of chronic diseases, including type 2 diabetes mellitus, dyslipidaemia, and hypertension, through a multicomponent approach that enhances dietary habits, physical activity, and emotional eating regulation.
Read more
Objectives
- Assess the effectiveness of the Energy2MOB programme in reducing body weight by 5-10% among adults with obesity in the Berguedà health region.
- Measure lifestyle modifications, including dietary habits, physical activity, and emotional eating.
Methodology: A randomised clinical trial with two groups (control and intervention) over one year, including individuals aged 18-65 years in the Berguedà health region with overweight grade II (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²). Exclusion criteria include significant language barriers, previous bariatric surgery, moderate to severe cognitive impairment, and severe psychiatric disorders preventing participation in sessions. Participants must attend at least 80% of the programme.
Measurements
- Sociodemographic factors: sex, age, education level, marital status, employment status.
- Lifestyle factors: alcohol and tobacco use, dietary habits, physical activity, emotional eating, health-related quality of life.
- Anthropometric parameters: body weight, height, BMI, waist circumference.
- Blood pressure, medication use, biochemical parameters (fasting glucose, glycated haemoglobin, lipid profile, liver and kidney function markers, C-reactive protein).
Statistical Analysis: Accepting an alpha risk of 0.05 and a statistical power above 0.8 in a bilateral contrast, 68 subjects per group are required to detect a difference of at least 2.5 kg. A common standard deviation of 4.77 is assumed, with an estimated 15% dropout rate. Sample size calculations were performed using GRANMO version 8.0 (https://www.datarus.eu/ca/aplications/granmo/; consulted in November 2024).
Expected Outcomes, Applicability, and Relevance: This study aims to generate scientific evidence on the effectiveness of multicomponent group-based interventions focused on improving nutrition, physical activity, and psychological well-being in obesity and chronic disease management. It seeks to create an environment that facilitates behavioural changes, leading to weight reduction and improved quality of life. The findings will also contribute to the development of a practical guide for addressing excess weight in primary healthcare settings.
Keywords (maximum 6): Adult obesity, primary health care, group interventions, dietary interventions, multicomponent interventions, Mediterranean diet.
Read the detailed description
BACKGROUND AND CURRENT STATE OF THE TOPIC Obesity is a chronic, complex, and prevalent disease worldwide, posing a significant public health concern with high socio-economic costs. The World Health Organization (WHO) defines it as an abnormal or excessive accumulation of fat that impairs health, promotes medical complications, and reduces life expectancy.
Recent studies indicate that obesity prevalence has risen in recent years and is projected to continue increasing. According to a recent study by the Carlos III Health Institute in collaboration with the Spanish Agency for Food Safety and Nutrition (AESAN) and regional health services, 55.8% of adults are overweight (63.7% of men and 48.4% of women), and 18.7% have obesity (19.3% of men and 18.0% of women). Among children and adolescents, 10.7% have obesity, and 30% are overweight. More specifically, the 2022 Catalonia Health Survey reports that half of the population aged 18-74 years has excess weight, including overweight and obesity, with 56.2% of men and 43.7% of women affected. Among children aged 6-12 years, nearly 39% have excess body weight, with 25.2% classified as overweight and 13.7% as obese.
There is no doubt that modern society fosters an obesogenic environment, promoting sedentary lifestyles and unhealthy diets dominated by processed foods. However, additional factors predispose individuals to excess weight even without exposure to these obesogenic influences. Obesity is a multifactorial disease, involving both intrinsic (non-modifiable) factors such as genetics and physiological causes and extrinsic (modifiable) factors such as environmental, psychological, social, economic, and political influences.
Physiopathologically, obesity is characterised by chronic low-grade inflammation due to adipose tissue dysfunction caused by excessive and/or abnormal fat accumulation. Excess adiposity is a major health risk as it is associated with a broad range of chronic diseases, including cardiovascular disease, type 2 diabetes mellitus, certain cancers, mental health disorders, chronic kidney disease, musculoskeletal complications, respiratory diseases, and non-alcoholic fatty liver disease (NAFLD). Addressing this issue with evidence-based solutions is urgent and a public health priority.
Expert groups, including the National Institutes of Health, WHO, the Academy of Nutrition and Dietetics, and the Spanish Society for the Study of Obesity (SEEDO), recommend a 5-10% reduction in initial body weight over six months to achieve health benefits and manage obesity-related comorbidities. Such weight loss is associated with reductions in body mass index (BMI), waist circumference, and fat mass, alongside significant improvements in glucose levels, lipid profile, and blood pressure. Consequently, obesity reduction strategies offer substantial benefits for chronic disease management, particularly type 2 diabetes mellitus, dyslipidaemia, and hypertension.
Beyond its impact on physical health, obesity also affects emotional, psychological, and social well-being. Weight-related stigma, discrimination, and bias contribute to decreased quality of life and increased obesity-related comorbidities. Current scientific evidence highlights that body weight regulation is not solely under voluntary control, as biological, genetic, and environmental factors play fundamental roles in obesity development and maintenance. Ineffective weight loss outcomes, insufficient multidisciplinary coordination, a lack of human and economic resources for obesity management, and societal misperceptions about obesity-particularly in lower socioeconomic groups-contribute to the overburdening of healthcare systems, preventing comprehensive and high-quality patient care.
Therefore, obesity treatment must adopt a holistic approach to achieve long-term health and well-being improvements. The focus should shift from mere weight reduction to sustainable lifestyle changes, including dietary modifications, increased physical activity, and psychological well-being improvements. Effective intervention requires a multidisciplinary team of specialists (e.g., dietitians-nutritionists, physicians, nurses, psychologists, and physical activity experts) working collaboratively to enhance patient health and well-being.
More specifically, interventions should promote a well-balanced diet alongside regular physical activity and behavioural therapy to sustain long-term lifestyle changes. The Mediterranean diet, a well-established cardioprotective dietary model in the region, serves as the basis for this approach. It emphasises a high intake of natural plant-based fats (extra virgin olive oil and nuts), minimally processed plant-based foods (vegetables, fruits, legumes, and whole grains), limited meat consumption (especially red and processed meats), moderate fish and egg consumption, and minimal intake of ultra-processed foods high in saturated fats, trans fats, and added sugars.
Regular physical activity and exercise are crucial in obesity treatment as they enhance weight loss, reduce abdominal fat, support weight maintenance, improve well-being, and positively impact cardiovascular risk factors. Psychological therapy plays an essential role, incorporating motivational strategies, problem-solving techniques, stimulus control, and stress reduction techniques. The COM-B behaviour change model will underpin the multicomponent group education intervention, ensuring participant motivation and engagement throughout all obesity treatment phases-critical for achieving successful outcomes.
Although several scientific studies have demonstrated the effectiveness of lifestyle modification-based group interventions, their implementation in primary healthcare settings remains limited due to a shortage of trained professionals with adequate availability. This highlights the need for resource allocation to address the issue effectively. Developing and implementing specific programmes based on a collaborative and interdisciplinary care model is crucial for successfully managing obesity and its associated health consequences. Such initiatives could improve the prevalence of cardiometabolic risk factors in affected individuals.
In 2021, the Catalan primary healthcare system incorporated dietitians-nutritionists through the Programme for the Promotion of Healthy Eating and the Prevention and Management of Diseases in Primary and Community Healthcare. These professionals focus on preventing and treating nutrition-related health issues by promoting healthy and sustainable eating habits tailored to individual conditions, risks, diseases, preferences, and socio-economic and cultural circumstances, with a particular focus on vulnerable populations. Additionally, primary healthcare introduced other roles, such as emotional well-being and community health specialists and physiotherapists, to facilitate the implementation of such programmes.
This project builds on prior obesity management interventions in primary healthcare settings, incorporating insights from past participants to refine and enhance its effectiveness. It has the potential to generate robust evidence on the effectiveness of multicomponent group-based interventions for obesity and chronic disease management in adults, providing a supportive environment that fosters sustainable behaviour change for improved patient quality of life and optimal health outcomes. If the intervention proves successful, a practical guide will be developed for broader implementation across primary healthcare centres addressing adult obesity.
HYPOTHESIS Participation in the Energy2MOB group education programme for obesity management in Berguedà will lead to a reduction in body weight among individuals with overweight or obesity. Additionally, it will improve dietary habits, physical activity levels, and emotional eating behaviour, while also supporting the management of chronic diseases such as type 2 diabetes mellitus, dyslipidaemia, and hypertension.
OBJECTIVES Primary Objectives (PO)
- PO1: To assess the effectiveness of the Energy2MOB programme in achieving a 5-10% reduction in body weight among adults with overweight or obesity in the Berguedà healthcare region.
- PO2: To determine lifestyle changes related to adherence to the Mediterranean diet, regular physical activity, and improved emotional eating regulation.
Secondary Objectives (SO)
- SO1: To evaluate changes in biochemical, anthropometric, and blood pressure parameters.
- SO2: To analyse improvements in health-related quality of life, reduction in cardiovascular risk, and better management of comorbidities (hypertension, dyslipidaemia, and diabetes mellitus).
- SO3: To examine the feasibility of implementing the programme by assessing adherence, fidelity, and participant satisfaction.
- Conditions
- Mediterranean Diet, Overweight or Obese Adults, Exercise Therapy, Cardiovascular Diseases, Psychological Well Being
- Being tested
- Energy2MOB
- Keywords
- obesity and overweight, primary health care, Mediterranean diet, dietary interventions
- Medical subject headings
- Overweight, Cardiovascular Diseases, Psychological Well-Being, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy2MOBOther
Intervention: The Energy2MOB programme will take place at three primary healthcare centres in Berguedà:
Baix Berguedà (Puig-Reig CAP) Berga Centre (Berga CAP) Alt Berguedà (Guardiola de Berguedà CAP)
The programme will include:
One pre-intervention visit 8 weekly group sessions One post-intervention visit One-month telephone follow-up In-person follow-ups at three and six months
The control group will continue with standard care at their usual primary healthcare centre and will only attend pre-intervention, post-intervention, and six-month follow-up visits. They will not receive group sessions or telephone follow-ups. If the Energy2MOB programme proves effective, control group participants will be invited to participate in the intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Intervention: The Energy2MOB programme will take place at three primary healthcare centres in Berguedà: Baix Berguedà (Puig-Reig CAP), Berga Centre (Berga CAP), Alt Berguedà (Guardiola de Berguedà CAP)
The programme will include:
* One pre-intervention visit
* 8 weekly group sessions
* One post-intervention visit
* One-month telephone follow-up
* In-person follow-ups at three and six months Receives: Other: Energy2MOB |
| Control group | No intervention | The control group will continue with standard care at their usual primary healthcare centre and will only attend pre-intervention, post-intervention, and six-month follow-up visits. They will not receive group sessions or telephone follow-ups. If the Energy2MOB programme proves effective, control group participants will be invited to participate in the intervention sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changed
Body weight changed refers to the process of losing body weight, typically through a combination of diet, exercise, and lifestyle changes. It is aimed at changing excess body fat, improving health, and achieving a healthier body composition. This changed can vary depending on the individual's goals, metabolic rate, and overall health.
Measured: 1 year
Secondary outcomes (29)
Body weight
Calibrated scale, measured with light clothing and without shoes, in kilograms
Measured: 1 year
Height
With stadiometer, mesured in metres
Measured: 1 year
Waist circumference
Measured at the level of the navel using a flexible measuring tape, in centimetres
Measured: 1 year
BMI (Body Mass Index)
Weight and height will be combined to report BMI in kg/m^2
Measured: 1 year
Obesity-Related Comorbidities
Hypertension, dyslipidaemia/hypercholesterolaemia, type 2 diabetes mellitus, Fibromyalgia, cardiovascular disease, sleep apnoea syndrome, Osteoarticular pathology, non-alcoholic fatty liver disease (NAFLD), urinary incontinence
Measured: 1 year
Medication Use
Medication used for comorbidities associated with obesity refers to drugs prescribed to manage health conditions that often occur alongside obesity, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. These medications help control the symptoms and prevent further complications related to these comorbidities.
Measured: 1 year
Blood Pressure (systolic and diastolic)
Blood pressure refers to the force exerted by circulating blood on the walls of blood vessels. It is measured in two values: systolic and diastolic.
Systolic blood pressure is the higher number and represents the pressure in the arteries when the heart contracts and pumps blood.
Diastolic blood pressure is the lower number and measures the pressure in the arteries when the heart is at rest between beats.
Normal blood pressure is typically around 120/80 mmHg. Blood pressure higher than 130/80 mmHg is considered elevated or high, which can increase the risk of cardiovascular diseases, strokes, and kidney problems. Monitoring and managing blood pressure is essential for maintaining overall health, particularly in individuals with obesity or other risk factors.
Measured: 1 year
Fasting plasma glucose
Plasma glucose refers to the concentration of glucose (sugar) in the liquid component of blood. It serves as a primary energy source for the body's cells. Measuring plasma glucose is essential for diagnosing and monitoring metabolic conditions such as diabetes mellitus. Normal fasting levels typically range between 70 and 100 mg/dL.
Measured: 1 year
Glycated haemoglobin (HbA1c)
Glycated haemoglobin (HbA1c) reflects the average blood glucose levels over the past two to three months. It forms when glucose binds to hemoglobin in red blood cells. HbA1c is widely used to diagnose and monitor diabetes. Normal values are generally below 5.7%, with higher levels indicating poor long-term glucose control.
Measured: 1 year
Smoking status
Current smoker, former smoker, non-smoker
Measured: 1 year
Cardiovascular risk
Assessed using validated risk score tools, REGICOR calculator. TABLES FOR CALCULATING 10-YEAR CORONARY RISK: <5% Low risk, 5-9.9% Moderate risk, 10-14.9% High risk, ≥15% Very high risk
Measured: 1 year
Mediterranean diet adherence
Adherence to the Mediterranean diet through the validated MEDAS questionnaire: <9 low adherence, >= 9 good adherence
Measured: 1 year
Dietary habits evaluation
Eating behaviour questionnaire
Measured: 1 year
Physical activity level
International Physical Activity Questionnaire (IPAQ) short version. Results:
- Low. They do not record physical activity, or they record it but it does not meet the medium or high categories.
- Medium. Considers the following criteria: 3 or more days of vigorous physical activity of at least 20 minutes per day. 5 or more days of moderate-intensity physical activity or walking of at least 30 minutes. 5 or more days of any combination of light, moderate, or vigorous physical activity that reach a record of 600 METs-min/week.
- High. This is a high category and meets the following requirements: 3 or more days of vigorous physical activity or that accumulate 1,500 METs-min/week. 7 or more days of any combination of light, moderate, or vigorous physical activity that reach a record of 3,000 METs-min/week.
Measured: 1 year
Emotional eating assessment
Emotional Eating Questionnaire (CCE) Garaulet. Scale scores: unemotional eater 0 to 5, mildly emotional eater 6 to 10, emotional eater 11 to 20, and highly emotional eater 21 to 30 points.
Measured: 1 year
Health-related quality of life
EuroQol-5D (EQ-5D) with Visual Analogue Scale (VAS): Improvement in Health-Related Quality of Life (HRQoL) after the intervention: an improvement in HRQoL is considered if there is a decrease in the EuroQol (EQ-5D) questionnaire score compared to the baseline. A set of values consists of weights that convert each EQ-5D health profile into a value on a scale anchored between 1 (meaning complete health) and 0 (meaning a condition as serious as death).
Measured: 1 year
Programme adherence
Based on participant attendance records
Measured: 1 year
Intervention fidelity
Nomber of participants with completion of planned activities in each session
Measured: 1 year
Programme satisfaction
Participant feedback survey
Measured: 1 year
Total cholesterol
Total cholesterol measures the overall amount of cholesterol in the blood, including LDL (bad), HDL (good), and other lipid components. It is an important marker for cardiovascular health. High levels are associated with an increased risk of heart disease and stroke. Desirable values are generally below 200 mg/dL.
Measured: 1 year
HDL cholesterol
HDL cholesterol (high-density lipoprotein) is known as the "good" cholesterol because it helps remove excess cholesterol from the bloodstream. Higher HDL levels are associated with a lower risk of cardiovascular disease. It plays a protective role in heart health. Optimal levels are typically above 60 mg/dL.
Measured: 1 year
LDL cholesterol
LDL cholesterol (low-density lipoprotein) is often referred to as the "bad" cholesterol because high levels can lead to plaque buildup in the arteries, increasing the risk of cardiovascular disease. It is a key marker in assessing heart health. Optimal levels are typically below 100 mg/dL.
Measured: 1 year
Triglycerides
Triglycerides are a type of fat (lipid) found in the blood, used by the body for energy. High levels can increase the risk of cardiovascular disease, especially when combined with low HDL or high LDL cholesterol. Normal fasting levels are typically below 150 mg/dL.
Measured: 1 year
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) is an enzyme primarily found in the liver that helps convert proteins into energy for liver cells. Elevated ALT levels in the blood may indicate liver damage or inflammation. Normal values typically range from 7 to 56 U/L.
Measured: 1 year
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) is an enzyme found in the liver, heart, muscles, and other tissues. It plays a role in amino acid metabolism. Elevated AST levels can indicate liver injury or damage to other organs. Normal levels usually range from 10 to 40 U/L.
Measured: 1 year
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase (GGT) is an enzyme primarily found in the liver and bile ducts. It is involved in the metabolism of glutathione and the transport of amino acids. Elevated GGT levels are commonly used as a marker of liver disease, alcohol consumption, or bile duct obstruction. Normal values typically range from 0 to 30 U/L.
Measured: 1 year
Creatinine
A waste product produced by muscles from the breakdown of creatine. It is filtered by the kidneys, and elevated levels in blood can indicate impaired kidney function.
Measured: 1 year
Glomerular Filtration Rate (GFR)
A measure of kidney function that indicates how well the kidneys are filtering waste from the blood. It is calculated based on factors like age, sex, and creatinine levels.
Measured: 1 year
C-reactive Protein (CRP)
A protein produced by the liver in response to inflammation. High levels of CRP in the blood can indicate inflammation or infection in the body.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start7 Jun 2025 (estimated)
- Primary completion7 Mar 2026 (estimated)
- Study completion7 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Mediterranean DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Ruiz Comellas, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988904
- Sponsor's protocol ID
- 24/303-P
- Acronym
- ENERGY2MOB
- Status last verified
- May 2025
- First submitted
- 8 Feb 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garaulet M, Canteras M, Morales E, Lopez-Guimera G, Sanchez-Carracedo D, Corbalan-Tutau MD. Validation of a questionnaire on emotional eating for use in cases of obesity: the Emotional Eater Questionnaire (EEQ). Nutr Hosp. 2012 Mar-Apr;27(2):645-51. doi: 10.1590/S0212-16112012000200043.
PubMed 22732995Jeschke N, Nelson PE, Marasas WF. Toxicity to ducklings of Fusarium moniliforme isolated from corn intended for use in poultry feed. Poult Sci. 1987 Oct;66(10):1619-23. doi: 10.3382/ps.0661619.
PubMed 3432189Garcia-Alvarez A, Serra-Majem L, Ribas-Barba L, Castell C, Foz M, Uauy R, Plasencia A, Salleras L. Obesity and overweight trends in Catalonia, Spain (1992-2003): gender and socio-economic determinants. Public Health Nutr. 2007 Nov;10(11A):1368-78. doi: 10.1017/S1368980007000973.
PubMed 17988408Ahern AL, Wheeler GM, Aveyard P, Boyland EJ, Halford JCG, Mander AP, Woolston J, Thomson AM, Tsiountsioura M, Cole D, Mead BR, Irvine L, Turner D, Suhrcke M, Pimpin L, Retat L, Jaccard A, Webber L, Cohn SR, Jebb SA. Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial. Lancet. 2017 Jun 3;389(10085):2214-2225. doi: 10.1016/S0140-6736(17)30647-5. Epub 2017 May 3.
PubMed 28478041Gomez-Huelgas R, Jansen-Chaparro S, Baca-Osorio AJ, Mancera-Romero J, Tinahones FJ, Bernal-Lopez MR. Effects of a long-term lifestyle intervention program with Mediterranean diet and exercise for the management of patients with metabolic syndrome in a primary care setting. Eur J Intern Med. 2015 Jun;26(5):317-23. doi: 10.1016/j.ejim.2015.04.007. Epub 2015 Apr 20.
PubMed 25907985Leblanc ES, O'Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011 Oct 4;155(7):434-47. doi: 10.7326/0003-4819-155-7-201110040-00006.
PubMed 21969342Paul-Ebhohimhen V, Avenell A. A systematic review of the effectiveness of group versus individual treatments for adult obesity. Obes Facts. 2009;2(1):17-24. doi: 10.1159/000186144. Epub 2009 Feb 3.
PubMed 20054200Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Jebb SA, Ahern AL, Olson AD, Aston LM, Holzapfel C, Stoll J, Amann-Gassner U, Simpson AE, Fuller NR, Pearson S, Lau NS, Mander AP, Hauner H, Caterson ID. Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial. Lancet. 2011 Oct 22;378(9801):1485-92. doi: 10.1016/S0140-6736(11)61344-5. Epub 2011 Sep 7.
PubMed 21906798Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, Schwarz P; IMAGE Study Group. Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health. 2011 Feb 18;11:119. doi: 10.1186/1471-2458-11-119.
PubMed 21333011Salas-Salvado J, Diaz-Lopez A, Ruiz-Canela M, Basora J, Fito M, Corella D, Serra-Majem L, Warnberg J, Romaguera D, Estruch R, Vidal J, Martinez JA, Aros F, Vazquez C, Ros E, Vioque J, Lopez-Miranda J, Bueno-Cavanillas A, Tur JA, Tinahones FJ, Martin V, Lapetra J, Pinto X, Daimiel L, Delgado-Rodriguez M, Matia P, Gomez-Gracia E, Diez-Espino J, Babio N, Castaner O, Sorli JV, Fiol M, Zulet MA, Bullo M, Goday A, Martinez-Gonzalez MA; PREDIMED-Plus investigators. Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial. Diabetes Care. 2019 May;42(5):777-788. doi: 10.2337/dc18-0836. Epub 2018 Nov 2.
PubMed 30389673Gomez Puente JM, Martinez-Marcos M. Overweight and obesity: effectiveness of interventions in adults. Enferm Clin (Engl Ed). 2018 Jan-Feb;28(1):65-74. doi: 10.1016/j.enfcli.2017.06.005. Epub 2017 Dec 21. English, Spanish.
PubMed 29274691Look AHEAD Research Group; Wadden TA, West DS, Delahanty L, Jakicic J, Rejeski J, Williamson D, Berkowitz RI, Kelley DE, Tomchee C, Hill JO, Kumanyika S. The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it. Obesity (Silver Spring). 2006 May;14(5):737-52. doi: 10.1038/oby.2006.84.
PubMed 16855180Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, Miller ER 3rd, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959-68. doi: 10.1056/NEJMoa1108660. Epub 2011 Nov 15.
PubMed 22085317Wharton S, Lau DCW, Vallis M, Sharma AM, Biertho L, Campbell-Scherer D, Adamo K, Alberga A, Bell R, Boule N, Boyling E, Brown J, Calam B, Clarke C, Crowshoe L, Divalentino D, Forhan M, Freedhoff Y, Gagner M, Glazer S, Grand C, Green M, Hahn M, Hawa R, Henderson R, Hong D, Hung P, Janssen I, Jacklin K, Johnson-Stoklossa C, Kemp A, Kirk S, Kuk J, Langlois MF, Lear S, McInnes A, Macklin D, Naji L, Manjoo P, Morin MP, Nerenberg K, Patton I, Pedersen S, Pereira L, Piccinini-Vallis H, Poddar M, Poirier P, Prud'homme D, Salas XR, Rueda-Clausen C, Russell-Mayhew S, Shiau J, Sherifali D, Sievenpiper J, Sockalingam S, Taylor V, Toth E, Twells L, Tytus R, Walji S, Walker L, Wicklum S. Obesity in adults: a clinical practice guideline. CMAJ. 2020 Aug 4;192(31):E875-E891. doi: 10.1503/cmaj.191707. No abstract available.
PubMed 32753461
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF THE GROUP-BASED NUTRITION EDUCATION PROGRAMME FOR OBESITY MANAGEMENT IN BERGUEDÀ: A RANDOMISED CLINICAL TRIAL. ENERGY2MOB STUDY
- ClinicalTrials.gov ID
- NCT06988904
- Acronym / sponsor ID
- ENERGY2MOB / 24/303-P
- Conditions
- Mediterranean Diet, Overweight or Obese Adults, Exercise Therapy, Cardiovascular Diseases, Psychological Well Being
- Keywords
- obesity and overweight, primary health care, Mediterranean diet, dietary interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 7 Jun 2025 (estimated)
- Primary completion
- 7 Mar 2026 (estimated)
- Study completion
- 7 Mar 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Obesity is a prevalent multifactorial disease worldwide and has become a significant public health concern. The latest data from the 2022 Catalonia Health Survey show that 56.2% of men and 43.7% of women are overweight or obese, and 39% of children aged 6 to 12 years have excess weight. Excess adiposity poses a health risk as it is associated with various chronic diseases such as type 2 diabetes mellitus, hypertension, and dyslipidaemia, all of which affect quality of life and increase mortality risk.
Hypothesis: The Energy2MOB obesity management programme in Berguedà is a group-based intervention incorporating nutrition education and physical activity. It aims to reduce excess body weight and the risk of chronic diseases, including type 2 diabetes mellitus, dyslipidaemia, and hypertension, through a multicomponent approach that enhances dietary habits, physical activity, and emotional eating regulation.
Objectives
- Assess the effectiveness of the Energy2MOB programme in reducing body weight by 5-10% among adults with obesity in the Berguedà health region.
- Measure lifestyle modifications, including dietary habits, physical activity, and emotional eating.
Methodology: A randomised clinical trial with two groups (control and intervention) over one year, including individuals aged 18-65 years in the Berguedà health region with overweight grade II (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²). Exclusion criteria include significant language barriers, previous bariatric surgery, moderate to severe cognitive impairment, and severe psychiatric disorders preventing participation in sessions. Participants must attend at least 80% of the programme.
Measurements
- Sociodemographic factors: sex, age, education level, marital status, employment status.
- Lifestyle factors: alcohol and tobacco use, dietary habits, physical activity, emotional eating, health-related quality of life.
- Anthropometric parameters: body weight, height, BMI, waist circumference.
- Blood pressure, medication use, biochemical parameters (fasting glucose, glycated haemoglobin, lipid profile, liver and kidney function markers, C-reactive protein).
Statistical Analysis: Accepting an alpha risk of 0.05 and a statistical power above 0.8 in a bilateral contrast, 68 subjects per group are required to detect a difference of at least 2.5 kg. A common standard deviation of 4.77 is assumed, with an estimated 15% dropout rate. Sample size calculations were performed using GRANMO version 8.0 (https://www.datarus.eu/ca/aplications/granmo/; consulted in November 2024).
Expected Outcomes, Applicability, and Relevance: This study aims to generate scientific evidence on the effectiveness of multicomponent group-based interventions focused on improving nutrition, physical activity, and psychological well-being in obesity and chronic disease management. It seeks to create an environment that facilitates behavioural changes, leading to weight reduction and improved quality of life. The findings will also contribute to the development of a practical guide for addressing excess weight in primary healthcare settings.
Keywords (maximum 6): Adult obesity, primary health care, group interventions, dietary interventions, multicomponent interventions, Mediterranean diet.
Detailed description
BACKGROUND AND CURRENT STATE OF THE TOPIC Obesity is a chronic, complex, and prevalent disease worldwide, posing a significant public health concern with high socio-economic costs. The World Health Organization (WHO) defines it as an abnormal or excessive accumulation of fat that impairs health, promotes medical complications, and reduces life expectancy.
Recent studies indicate that obesity prevalence has risen in recent years and is projected to continue increasing. According to a recent study by the Carlos III Health Institute in collaboration with the Spanish Agency for Food Safety and Nutrition (AESAN) and regional health services, 55.8% of adults are overweight (63.7% of men and 48.4% of women), and 18.7% have obesity (19.3% of men and 18.0% of women). Among children and adolescents, 10.7% have obesity, and 30% are overweight. More specifically, the 2022 Catalonia Health Survey reports that half of the population aged 18-74 years has excess weight, including overweight and obesity, with 56.2% of men and 43.7% of women affected. Among children aged 6-12 years, nearly 39% have excess body weight, with 25.2% classified as overweight and 13.7% as obese.
There is no doubt that modern society fosters an obesogenic environment, promoting sedentary lifestyles and unhealthy diets dominated by processed foods. However, additional factors predispose individuals to excess weight even without exposure to these obesogenic influences. Obesity is a multifactorial disease, involving both intrinsic (non-modifiable) factors such as genetics and physiological causes and extrinsic (modifiable) factors such as environmental, psychological, social, economic, and political influences.
Physiopathologically, obesity is characterised by chronic low-grade inflammation due to adipose tissue dysfunction caused by excessive and/or abnormal fat accumulation. Excess adiposity is a major health risk as it is associated with a broad range of chronic diseases, including cardiovascular disease, type 2 diabetes mellitus, certain cancers, mental health disorders, chronic kidney disease, musculoskeletal complications, respiratory diseases, and non-alcoholic fatty liver disease (NAFLD). Addressing this issue with evidence-based solutions is urgent and a public health priority.
Expert groups, including the National Institutes of Health, WHO, the Academy of Nutrition and Dietetics, and the Spanish Society for the Study of Obesity (SEEDO), recommend a 5-10% reduction in initial body weight over six months to achieve health benefits and manage obesity-related comorbidities. Such weight loss is associated with reductions in body mass index (BMI), waist circumference, and fat mass, alongside significant improvements in glucose levels, lipid profile, and blood pressure. Consequently, obesity reduction strategies offer substantial benefits for chronic disease management, particularly type 2 diabetes mellitus, dyslipidaemia, and hypertension.
Beyond its impact on physical health, obesity also affects emotional, psychological, and social well-being. Weight-related stigma, discrimination, and bias contribute to decreased quality of life and increased obesity-related comorbidities. Current scientific evidence highlights that body weight regulation is not solely under voluntary control, as biological, genetic, and environmental factors play fundamental roles in obesity development and maintenance. Ineffective weight loss outcomes, insufficient multidisciplinary coordination, a lack of human and economic resources for obesity management, and societal misperceptions about obesity-particularly in lower socioeconomic groups-contribute to the overburdening of healthcare systems, preventing comprehensive and high-quality patient care.
Therefore, obesity treatment must adopt a holistic approach to achieve long-term health and well-being improvements. The focus should shift from mere weight reduction to sustainable lifestyle changes, including dietary modifications, increased physical activity, and psychological well-being improvements. Effective intervention requires a multidisciplinary team of specialists (e.g., dietitians-nutritionists, physicians, nurses, psychologists, and physical activity experts) working collaboratively to enhance patient health and well-being.
More specifically, interventions should promote a well-balanced diet alongside regular physical activity and behavioural therapy to sustain long-term lifestyle changes. The Mediterranean diet, a well-established cardioprotective dietary model in the region, serves as the basis for this approach. It emphasises a high intake of natural plant-based fats (extra virgin olive oil and nuts), minimally processed plant-based foods (vegetables, fruits, legumes, and whole grains), limited meat consumption (especially red and processed meats), moderate fish and egg consumption, and minimal intake of ultra-processed foods high in saturated fats, trans fats, and added sugars.
Regular physical activity and exercise are crucial in obesity treatment as they enhance weight loss, reduce abdominal fat, support weight maintenance, improve well-being, and positively impact cardiovascular risk factors. Psychological therapy plays an essential role, incorporating motivational strategies, problem-solving techniques, stimulus control, and stress reduction techniques. The COM-B behaviour change model will underpin the multicomponent group education intervention, ensuring participant motivation and engagement throughout all obesity treatment phases-critical for achieving successful outcomes.
Although several scientific studies have demonstrated the effectiveness of lifestyle modification-based group interventions, their implementation in primary healthcare settings remains limited due to a shortage of trained professionals with adequate availability. This highlights the need for resource allocation to address the issue effectively. Developing and implementing specific programmes based on a collaborative and interdisciplinary care model is crucial for successfully managing obesity and its associated health consequences. Such initiatives could improve the prevalence of cardiometabolic risk factors in affected individuals.
In 2021, the Catalan primary healthcare system incorporated dietitians-nutritionists through the Programme for the Promotion of Healthy Eating and the Prevention and Management of Diseases in Primary and Community Healthcare. These professionals focus on preventing and treating nutrition-related health issues by promoting healthy and sustainable eating habits tailored to individual conditions, risks, diseases, preferences, and socio-economic and cultural circumstances, with a particular focus on vulnerable populations. Additionally, primary healthcare introduced other roles, such as emotional well-being and community health specialists and physiotherapists, to facilitate the implementation of such programmes.
This project builds on prior obesity management interventions in primary healthcare settings, incorporating insights from past participants to refine and enhance its effectiveness. It has the potential to generate robust evidence on the effectiveness of multicomponent group-based interventions for obesity and chronic disease management in adults, providing a supportive environment that fosters sustainable behaviour change for improved patient quality of life and optimal health outcomes. If the intervention proves successful, a practical guide will be developed for broader implementation across primary healthcare centres addressing adult obesity.
HYPOTHESIS Participation in the Energy2MOB group education programme for obesity management in Berguedà will lead to a reduction in body weight among individuals with overweight or obesity. Additionally, it will improve dietary habits, physical activity levels, and emotional eating behaviour, while also supporting the management of chronic diseases such as type 2 diabetes mellitus, dyslipidaemia, and hypertension.
OBJECTIVES Primary Objectives (PO)
- PO1: To assess the effectiveness of the Energy2MOB programme in achieving a 5-10% reduction in body weight among adults with overweight or obesity in the Berguedà healthcare region.
- PO2: To determine lifestyle changes related to adherence to the Mediterranean diet, regular physical activity, and improved emotional eating regulation.
Secondary Objectives (SO)
- SO1: To evaluate changes in biochemical, anthropometric, and blood pressure parameters.
- SO2: To analyse improvements in health-related quality of life, reduction in cardiovascular risk, and better management of comorbidities (hypertension, dyslipidaemia, and diabetes mellitus).
- SO3: To examine the feasibility of implementing the programme by assessing adherence, fidelity, and participant satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Energy2MOBIntervention: The Energy2MOB programme will take place at three primary healthcare centres in Berguedà: Baix Berguedà (Puig-Reig CAP), Berga Centre (Berga CAP), Alt Berguedà (Guardiola de Berguedà CAP) The programme will include: * One pre-intervention visit * 8 weekly group sessions * One post-intervention visit * One-month telephone follow-up * In-person follow-ups at three and six months |
| Control group | No intervention | –The control group will continue with standard care at their usual primary healthcare centre and will only attend pre-intervention, post-intervention, and six-month follow-up visits. They will not receive group sessions or telephone follow-ups. If the Energy2MOB programme proves effective, control group participants will be invited to participate in the intervention sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years
- Overweight (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²)
- Availability to attend at least 80% (6 out of 8) of the group sessions
Key exclusion criteria (4 listed)
- Significant language barriers (unable to communicate in Catalan or Spanish)
- Previous bariatric surgery
- Moderate to severe cognitive impairment
- Severe psychiatric disorders preventing participation in group sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy2MOBIntervention: The Energy2MOB programme will take place at three primary healthcare centres in Berguedà: Baix Berguedà (Puig-Reig CAP) Berga Centre (Berga CAP) Alt Berguedà (Guardiola de Berguedà CAP) The programme will include: One pre-intervention visit 8 weekly group sessions One post-intervention visit One-month telephone follow-up In-person follow-ups at three and six months The control group will continue with standard care at their usual primary healthcare centre and will only attend pre-intervention, post-intervention, and six-month follow-up visits. They will not receive group sessions or telephone follow-ups. If the Energy2MOB programme proves effective, control group participants will be invited to participate in the intervention sessions. | Other | Interventional group |
Primary outcome
Body weight changed
Time frame: 1 year
Body weight changed refers to the process of losing body weight, typically through a combination of diet, exercise, and lifestyle changes. It is aimed at changing excess body fat, improving health, and achieving a healthier body composition. This changed can vary depending on the individual's goals, metabolic rate, and overall health.
29 secondary outcomes
Body weight
Time frame: 1 year
Height
Time frame: 1 year
Waist circumference
Time frame: 1 year
BMI (Body Mass Index)
Time frame: 1 year
Obesity-Related Comorbidities
Time frame: 1 year
Medication Use
Time frame: 1 year
Blood Pressure (systolic and diastolic)
Time frame: 1 year
Fasting plasma glucose
Time frame: 1 year
Glycated haemoglobin (HbA1c)
Time frame: 1 year
Smoking status
Time frame: 1 year
Cardiovascular risk
Time frame: 1 year
Mediterranean diet adherence
Time frame: 1 year
Dietary habits evaluation
Time frame: 1 year
Physical activity level
Time frame: 1 year
Emotional eating assessment
Time frame: 1 year
Health-related quality of life
Time frame: 1 year
Programme adherence
Time frame: 1 year
Intervention fidelity
Time frame: 1 year
Programme satisfaction
Time frame: 1 year
Total cholesterol
Time frame: 1 year
HDL cholesterol
Time frame: 1 year
LDL cholesterol
Time frame: 1 year
Triglycerides
Time frame: 1 year
Alanine aminotransferase (ALT)
Time frame: 1 year
Aspartate aminotransferase (AST)
Time frame: 1 year
Gamma-glutamyl transferase (GGT)
Time frame: 1 year
Creatinine
Time frame: 1 year
Glomerular Filtration Rate (GFR)
Time frame: 1 year
C-reactive Protein (CRP)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Results publication: PubMed 22732995Garaulet M, Canteras M, Morales E, Lopez-Guimera G, Sanchez-Carracedo D, Corbalan-Tutau MD. Validation of a questionnaire on emotional eating for use in cases of obesity: the Emotional Eater Questionnaire (EEQ). Nutr Hosp. 2012 Mar-Apr;27(2):645-51. doi: 10.1590/S0212-16112012000200043.
- Results publication: PubMed 3432189Jeschke N, Nelson PE, Marasas WF. Toxicity to ducklings of Fusarium moniliforme isolated from corn intended for use in poultry feed. Poult Sci. 1987 Oct;66(10):1619-23. doi: 10.3382/ps.0661619.
- Results publication: PubMed 17988408Garcia-Alvarez A, Serra-Majem L, Ribas-Barba L, Castell C, Foz M, Uauy R, Plasencia A, Salleras L. Obesity and overweight trends in Catalonia, Spain (1992-2003): gender and socio-economic determinants. Public Health Nutr. 2007 Nov;10(11A):1368-78. doi: 10.1017/S1368980007000973.
- Results publication: PubMed 28478041Ahern AL, Wheeler GM, Aveyard P, Boyland EJ, Halford JCG, Mander AP, Woolston J, Thomson AM, Tsiountsioura M, Cole D, Mead BR, Irvine L, Turner D, Suhrcke M, Pimpin L, Retat L, Jaccard A, Webber L, Cohn SR, Jebb SA. Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial. Lancet. 2017 Jun 3;389(10085):2214-2225. doi: 10.1016/S0140-6736(17)30647-5. Epub 2017 May 3.
- Results publication: PubMed 25907985Gomez-Huelgas R, Jansen-Chaparro S, Baca-Osorio AJ, Mancera-Romero J, Tinahones FJ, Bernal-Lopez MR. Effects of a long-term lifestyle intervention program with Mediterranean diet and exercise for the management of patients with metabolic syndrome in a primary care setting. Eur J Intern Med. 2015 Jun;26(5):317-23. doi: 10.1016/j.ejim.2015.04.007. Epub 2015 Apr 20.
- Results publication: PubMed 21969342Leblanc ES, O'Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011 Oct 4;155(7):434-47. doi: 10.7326/0003-4819-155-7-201110040-00006.
- Results publication: PubMed 20054200Paul-Ebhohimhen V, Avenell A. A systematic review of the effectiveness of group versus individual treatments for adult obesity. Obes Facts. 2009;2(1):17-24. doi: 10.1159/000186144. Epub 2009 Feb 3.
- Results publication: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Results publication: PubMed 21906798Jebb SA, Ahern AL, Olson AD, Aston LM, Holzapfel C, Stoll J, Amann-Gassner U, Simpson AE, Fuller NR, Pearson S, Lau NS, Mander AP, Hauner H, Caterson ID. Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial. Lancet. 2011 Oct 22;378(9801):1485-92. doi: 10.1016/S0140-6736(11)61344-5. Epub 2011 Sep 7.
- Results publication: PubMed 21333011Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, Schwarz P; IMAGE Study Group. Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health. 2011 Feb 18;11:119. doi: 10.1186/1471-2458-11-119.
- Results publication: PubMed 30389673Salas-Salvado J, Diaz-Lopez A, Ruiz-Canela M, Basora J, Fito M, Corella D, Serra-Majem L, Warnberg J, Romaguera D, Estruch R, Vidal J, Martinez JA, Aros F, Vazquez C, Ros E, Vioque J, Lopez-Miranda J, Bueno-Cavanillas A, Tur JA, Tinahones FJ, Martin V, Lapetra J, Pinto X, Daimiel L, Delgado-Rodriguez M, Matia P, Gomez-Gracia E, Diez-Espino J, Babio N, Castaner O, Sorli JV, Fiol M, Zulet MA, Bullo M, Goday A, Martinez-Gonzalez MA; PREDIMED-Plus investigators. Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial. Diabetes Care. 2019 May;42(5):777-788. doi: 10.2337/dc18-0836. Epub 2018 Nov 2.
- Results publication: PubMed 29274691Gomez Puente JM, Martinez-Marcos M. Overweight and obesity: effectiveness of interventions in adults. Enferm Clin (Engl Ed). 2018 Jan-Feb;28(1):65-74. doi: 10.1016/j.enfcli.2017.06.005. Epub 2017 Dec 21. English, Spanish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy2MOB in people with Mediterranean Diet and Overweight or Obese Adults, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mar Gargallo Civil (+34 660274434, mgargallo.cc.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight changed (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988904, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.