Healthy SubjectsNCT06057324

Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

A study testing AI-based Apps, Mediterranean-based diet toolkit and activities and Healthy plant-based snacks in people with Healthy Subjects and Behavior, Health, run by Fundació Eurecat at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Subjects, Behavior, Health, Family
What is being tested?: AI-based Apps, Mediterranean-based diet toolkit and activities and Healthy plant-based snacks
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 1 siteSpain
Study dates: 1 Nov 2023to May 2025
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 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Families from any socioeconomic status with at least one child less than 12 years and one adolescent older than or equal to 12 years (overall age range 3 - 17 years) and that live together.
Signed informed consent (parents will sign on their own behalf and of the child under 12 years of age and the adolescent. The adolescent must also sign themselves).
To have a mobile phone, tablet, or computer with internet access.

Who cannot join

Having allergies or food intolerances to any of the snack ingredients: fruit, vegetables, legumes, cereals, seeds, nuts (only for children under 12 years).
Dislike any of the snacks (only for children under 12 years).
Mediterranean Diet Adherence Score (MEDAS) among 8-14 or KIDMED score among 8-12, which is a food pattern already highly concordant with the Mediterranean Diet.
Following a vegan diet any of the family members.
Following a prescribed long-term and strict diet for any reason, including diets for weight loss and diets for chronic metabolic or autoimmune disorders such as type 1 diabetes, celiac disease, inflammatory bowel disease or rheumatoid arthritis (any of the family members).
Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
No or limited access to the Internet.
Being unable to follow the study guidelines.

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

Eurecat, Technological Center of Catalonia, Nutrition and Health Unit
Reus, Tarragona, 43204

Other trials in Spain

About this study

Official title: Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks

The population from Mediterranean countries is abandoning the Mediterranean diet (MD) traditional dietary and lifestyle pattern moving to unhealthier habits because of profound cultural and socio-economic driven lifestyle changes. Families, particularly parents, are responsible for structuring children's early experiences with food and eating as well as for transmitting knowledge of the MD. Educational family approaches can not only lead to more solid food literacy and healthy habits for children in the family but can also improve dietary profiles for adults, thus preventing future health-related problems. There is a lack of adequate study protocol for inducing a positive dietary, environmental and lifestyle behaviour in the family setting. SWITCHtoHEALTHY study aims to evaluate the effects of a multi-component nutritional intervention deployed at family level on the adherence to the MD pattern in families from three Mediterranean countries.

A parallel, randomized, single blind controlled multicentric nutritional intervention study will be conducted in 480 families with children and adolescents among 3-17 years from Spain, Morocco, and Turkey over 13 months. Specifically, 160 families per country will be enrolled in a multi-component intervention and allocated to use digital interactive tools, hands-on educational materials and activities for adolescents, easy-to-eat healthy plant-based snacks for children, or a combination of two or three of the components. There will also be a control group that will receive general advice on healthy eating. The intervention study is scheduled to begin in November 2023.

Through the digital tools the parents will use an interactive App through which they will receive personalized weekly meal plans while the engagement of all the family will be prompted by using a life simulation game. A set of activities for adolescents based on a learning-through-play approach to be carried out within the family and at school will be developed by adolescents and voluntary schoolteachers through co-creation sessions. The innovative and sustainable plant-based snacks will be produced by local food companies and introduced in the children dietary plan as healthy alternatives for between meals. By using a full-factorial design, the independent and combined effects of each intervention component will be tested by comparing the 7 intervention groups with the control group.

Read the detailed description

The main outcome will be adherence to the MD assessed through MEDAS and KIDMED validated questionnaires in parents and children respectively. The effectiveness of the multi-component intervention will be evaluated by comparing the MEDAS and KIDMED scores between the control and intervention groups at baseline and at the end of the intervention.The secondary outcomes will include a set of anthropometrical, lifestyle, dietary and socio-economic indicators measured in all family members.

Standardized protocols will be used for the collection of data in the three countries. All data will be collected and evaluated by professional researchers and registered by researchers or study participants in a web platform. Lifestyle, diet, and socio-economic indicators will be self-reported by means of adapted online questionnaires for parent, adolescent, and child.

The study will be carried out in 2 phases:

Phase 1 (month 0 to month 9): the families will be included in the study, they will be assigned to the different intervention groups, and consumption patterns and lifestyle, diet, and socioeconomic indicators will be evaluated through specific questionnaires. In addition, the different educational materials, activities, digital interactive tools and healthy snacks will be developed prior to the start of the intervention study.
Phase 2 (month 10 to month 13): The intervention study will be deployed at family level. Each family will receive the educational materials, digital interactive tools and snacks developed in Phase 1 as assigned. In addition, anthropometric, lifestyle, dietary and socioeconomic indicators will be evaluated through questionnaires.

Three visits will be performed along the study, including one pre-assessment at the beginning of Phase 1 (baseline, month 0), one visit at the beginning of Phase 2 (month 11) and one visit at the end of Phase 2 (month 13).

The impact of the intervention on dietary factors, including MD adherence, diet quality, food intake and MD lifestyle habits, physical activity, and classical anthropometrical parameters, will be assessed in Phase 2 in a 3-month period. However, consumption behaviour and environmental and economic factors will be measured at the baseline (Phase 1) and at the end (Phase 2). The baseline point (month 0) is necessary to assess the aforementioned factors over the course of a year.

Conditions: Healthy Subjects, Behavior, Health, Family
Being tested: AI-based Apps, Mediterranean-based diet toolkit and activities, Healthy plant-based snacks, AI-based Apps + Mediterranean-based diet toolkit and activities, AI-based Apps + Healthy plant-based snacks
Keywords: Mediterranean Diet, Adherence, Family, Nutritional intervention, Sustainability, Educational Activities, Healthy Food Choice, Digital Technology, Healthy food
Medical subject headings: Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AI-based AppsDevice
Families which will use the digital interactive tools to empower parents in their daily dietary choices.
Mediterranean-based diet toolkit and activitiesBehavioural
Families which will receive educational materials and adolescents will perform educational activities.
Healthy plant-based snacksOther
Families in which children will include the snacks in their diet.
AI-based Apps + Mediterranean-based diet toolkit and activitiesOther
Families which will use the digital interactive tools and receive educational material, and adolescents will perform educational activities.
AI-based Apps + Healthy plant-based snacksOther
Families which will use the digital interactive tools and children will include the snacks in their diet.
Mediterranean-based diet toolkit and activities + Healthy plant-based snacksOther
Families which will receive educational material, adolescents will perform educational activities, and children will include the snacks in their diet.
AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacksOther
Families which will use the digital interactive tools and will receive educational material, children will include the snacks in their diet, and adolescents will perform educational activities.

Study groups in NCT06057324
Study group	Role	What they receive
Multi-component intervention groups	Experimental	Multi-component intervention with non-invasive approaches: -Digital interactive tools (AI-based Apps): They will consist of a combination of two Artificial Intelligence (AI) Apps that will be used by parents to empower them in their daily dietary choices for children's dietary plan. - Educational materials (Mediterranean-based diet toolkit) and activities: The toolkit will include a set of specific games and activities for kids designed to facilitate the ''learning through playing'' approach improving their understanding of different nutrition themes. The educational activities will be co-designed and carried out by adolescents outside of school hours. - Healthy plant-based snacks: They will be adapted to children's nutritional requirements and to be consumed in-between time on a daily basis. Based on local and traditional products for each country including vegetables, fruits, legumes, seeds and nuts as main ingredients. Receives: Device: AI-based Apps; Behavioral: Mediterranean-based diet toolkit and activities; Other: Healthy plant-based snacks; Other: AI-based Apps + Mediterranean-based diet toolkit and activities; Other: AI-based Apps + Healthy plant-based snacks; Other: Mediterranean-based diet toolkit and activities + Healthy plant-based snacks; Other: AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks
Control group	No intervention	Families which will not follow any intervention; they will receive basic Mediterranean guidelines for parents and their children.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in adherence to the Mediterranean Diet
The main outcome will be adherence to the MD measured through MEDAS questionnaire score in parents. The effectiveness of the multi-component intervention will be evaluated by comparing the MEDAS score between the control and intervention groups during the intervention period (Phase 2).
The MEDAS score is an extension of a 9-point score developed in the Prevention with Mediterranean Diet (PREDIMED) trial. A score of 14 points means maximum adherence to the Mediterranean Diet while a score below 7 points means low adherence.
Measured: Phase 2 (month 10 to month 13)
Change in adherence to the Mediterranean Diet
The main outcome will be adherence to the MD measured through KIDMED questionnaire score in children. The effectiveness of the multi-component intervention will be evaluated by comparing the KIDMED score between the control and intervention groups during the intervention period (Phase 2).
The KIDMED score ranges from 0 to 12 points, so a score greater than or equal to 8 points means optimal Mediterranean Diet adherence while a score below or equal to 3 points means very low-quality diet, and between 4 and 7 points means that need to improve the eating pattern to fit the Mediterranean pattern.
Measured: Phase 2 (month 10 to month 13)

Secondary outcomes (20)

Change in Body Mass Index values
BMI will be assessed by weight (kg) / height (m2) and using a body composition analyzer (Tanita). BMI values will be compared between control and intervention groups. Measured in all family members.
Measured: Phase 2 (month 10 to month 13)
Change in waist circumference values
Waist circumference (cm) will be measured at the umbilicus level using an anthropometric steel measuring tape. The obtained values will be compared between control and intervention groups. Measured in all family members.
Measured: Phase 2 (month 10 to month 13)
Change in blood pressure values
Systolic blood pressure and Diastolic blood pressure values (mmHg) will be monitored by using an automatic sphygmomanometer. The obtained results will be compared between control and intervention groups. Measured in all family members.
Measured: Phase 2 (month 10 to month 13)
Change in resting heart rate values
Resting heart rate values (bpm) will be monitored by using an automatic sphygmomanometer. The obtained results will be compared between control and intervention groups. Measured in all family members.
Measured: Phase 2 (month 10 to month 13)
Sociodemographic and socioeconomic data
Measured in parents and adolescents by an adapted questionnaire which will collect information regarding age, gender, household members, marital status, income, level of education and employment status.
Measured: Phase 1 (baseline)
Social factors data
Measured in parents, adolescents, and children over 8 years by an adapted questionnaire which will collect information regarding work flexibility and satisfaction, work-life balance, lifestyle, time spent with children, family decision making, and task responsibility.
Measured: Phase 1 (baseline)
Change in physical activity levels
Physical activity level will be measured by using the Physical Activity Questionnaires PAQ-C for children over 8 years. It consists of a 10-item validated scale. The resulting score ranges from 1 to 5. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity. The obtained scores will be compared between control and intervention groups.
Measured: Phase 2 (month 10 to month 13)
Change in physical activity levels
Physical activity level will be measured by using the International Physical Activity Questionnaire (IPAQ) for adults (parents). It consists of a 7-item short form with open-ended questions surrounding individuals' last 7-day recall of physical activity. Results are reported as categories (low activity levels, moderate activity levels or high activity levels). The obtained results will be compared between control and intervention groups.
Measured: Phase 2 (month 10 to month 13)
Change in quality of life
Quality of life will be measured by using the 5-level EQ-5D-5L scale (EuroQol Group) for adults (parents). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The obtained scores will be compared between control and intervention groups.
Measured: Phase 2 (month 10 to month 13)
Change in quality of life
Quality of life will be measured by using the KIDSCREEN questionnaire for adolescents and children over 8 years. This scale measures 10 health-related quality of life dimensions: Physical- (5 items), Psychological Well-being (6 items), Moods and Emotions (7 items), Self-Perception (5 items), Autonomy (5 items), Parent Relations and Home Life (6 items), Social Support and Peers (6 items), School Environment (6 items), Social Acceptance (Bullying) (3 items), Financial Resources (3 items). The obtained scores will be compared between control and intervention groups.
Measured: Phase 2 (month 10 to month 13)
Change in nutritional knowledge
Knowledge about food and nutrition will be measured using a short consumer-oriented nutrition knowledge questionnaire for adults. The questionnaire consists of a scale of 20 items where correct responses are scored as one, while incorrect responses, don't know-answers or blanks are scored as zero. The obtained final scores will be compared between control and intervention groups.
Measured: Phase 2 (month 10 to month 13)
Change in nutritional knowledge
Knowledge about food and nutrition will be measured using the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study questionnaire for adolescents. The questionnaire includes a total of 23 multiple-choice questions that can be categorized into specific subscales regarding knowledge of concepts (e.g. subscales 'Energy Intake and Energy Metabolism' or 'Physical Activity'), instrumental knowledge (e.g. subscale 'Nutrient Contents') and knowledge of causal relationships (e.g. subscales 'Sweeteners' or 'Oral Health'). Each question offers three possible answers (only one correct) and the 'don't know' category. Correct answers are scored as 1 and incorrect answers are scored as 0. Finally, the individual scores are summed up and calculated as a percentage of the total. The obtained final scores will be compared between control and intervention groups.
Measured: Phase 2 (month 10 to month 13)
Change in the health factor
The health factor will be assessed by the General Health Questionnaire (GHQ). This questionnaire will ask different aspects related to health and healthy lifestyle such as sleeping habits, hospitalization, or prescribed medications. The obtained results will be compared between control and intervention groups. Measured in all family members.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in Mediterranean Diet lifestyle habits
Measured in parents by the Mediterranean Lifestyle index (MEDLIFE), which will capture adherence to an overall Mediterranean healthy lifestyle. It consists of a 28-item questionnaire categorized into three blocks: (1) Mediterranean food consumption (15 items); (2) Mediterranean dietary habits (7 items); (3) Physical Activity, rest, social habits and conviviality (6 items). Each item is scored as 0 for not meeting the cutoff established for the item or 1 for meeting it, so that the complete MEDLIFE ranges from 0 to 28, with a higher value indicative of greater adherence to Mediterranean lifestyle. The obtained results will be compared between control and intervention groups.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in diet quality
Diet quality will be measured by using the Healthy Diet Index (HDI) for adults. It consists of seven weighted domains (meal pattern, grains, fruit and vegetables, fats, fish and meat, dairy, snacks, and treats). Within each domain, increasing points indicate a more healthy diet. The maximum total HDI is set at 100 points. The obtained results will be compared between control and intervention groups.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in diet quality
Diet quality will be measured by using the KIDMED questionnaire for adolescent and children. The KIDMED score ranges from 0 to 12 points, so a score greater than or equal to 8 points means optimal diet quality while a score below or equal to 3 points means very low-quality diet, and between 4 and 7 points means that need to improve the eating pattern. The obtained score will be compared between control and intervention groups.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in attitudes and beliefs in relation to food
Measured by an adapted questionnaire for parents. This questionnaire measures how the household income, parents' time spent with children, and parents' work experiences affect children's energy and fat intake and obesity-related outcomes. The obtained results will be compared between control and intervention groups.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in consumption behavior
The consumption patterns will be assessed by means of family weekly food purchases, food intakes and food waste. The food purchases will be monitored by family unit using shopping tickets collected for 1 week. The food intake will be measured in all family by a 7-day semi-weighted food record. The food waste will be calculated as the difference between families food purchases and consumption considering the initial and final food inventories. Food storage sheets will be used to estimate the balance between food purchased and stored at home.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in environmental impact
The environmental impact of food consumption will be assessed of the overall study and the intervention. The consumption quantities will be converted into kg of CO2 emission, land use and water footprint using existing tables in the literature on the environmental impacts of different food groups.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in economic impact
The economic impact of the overall study and the intervention will be estimated using the family shopping tickets. We will evaluate whether the interventions lead to any change in family food expenditures.
Measured: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 2023May 2025

First posted28 Sep 2023
Study start1 Nov 2023
Primary completionApr 2025 (estimated)
Study completionMay 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicentre, parallel, randomized, single-blind and controlled clinical trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 480 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06057324
Sponsor's protocol ID: SWITCHtoHEALTHY
Other IDs: 2133
Status last verified: Feb 2025
First submitted: 4 Aug 2023
Last updated: 3 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alonso-Dominguez R, Garcia-Ortiz L, Patino-Alonso MC, Sanchez-Aguadero N, Gomez-Marcos MA, Recio-Rodriguez JI. Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study). Nutrients. 2019 Jan 14;11(1):162. doi: 10.3390/nu11010162.
PubMed 30646500
Sichert-Hellert W, Beghin L, De Henauw S, Grammatikaki E, Hallstrom L, Manios Y, Mesana MI, Molnar D, Dietrich S, Piccinelli R, Plada M, Sjostrom M, Moreno LA, Kersting M; HELENA Study Group. Nutritional knowledge in European adolescents: results from the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study. Public Health Nutr. 2011 Dec;14(12):2083-91. doi: 10.1017/S1368980011001352. Epub 2011 Aug 2.
PubMed 21810282
Dickson-Spillmann M, Siegrist M, Keller C. Development and validation of a short, consumer-oriented nutrition knowledge questionnaire. Appetite. 2011 Jun;56(3):617-20. doi: 10.1016/j.appet.2011.01.034. Epub 2011 Feb 15.
PubMed 21310201
Ravens-Sieberer U, Gosch A, Abel T, Auquier P, Bellach BM, Bruil J, Dur W, Power M, Rajmil L; European KIDSCREEN Group. Quality of life in children and adolescents: a European public health perspective. Soz Praventivmed. 2001;46(5):294-302. doi: 10.1007/BF01321080.
PubMed 11759336
Sotos-Prieto M, Santos-Beneit G, Bodega P, Pocock S, Mattei J, Penalvo JL. VALIDATION OF A QUESTIONNAIRE TO MEASURE OVERALL MEDITERRANEAN LIFESTYLE HABITS FOR RESEARCH APPLICATION: THE MEDITERRANEAN LIFESTYLE INDEX (MEDLIFE). Nutr Hosp. 2015 Sep 1;32(3):1153-63. doi: 10.3305/nh.2015.32.3.9387.
PubMed 26319833
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694
Rodriguez-Rodriguez F, Galvez-Fernandez P, Huertas-Delgado FJ, Aranda-Balboa MJ, Saucedo-Araujo RG, Herrador-Colmenero M. Parent's sociodemographic factors, physical activity and active commuting are predictors of independent mobility to school. Int J Health Geogr. 2021 Jun 6;20(1):26. doi: 10.1186/s12942-021-00280-2.
PubMed 34090437
Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
PubMed 15482620
Quintana-Navarro GM, Alcala-Diaz JF, Lopez-Moreno J, Perez-Corral I, Leon-Acuna A, Torres-Pena JD, Rangel-Zuniga OA, Arenas de Larriva AP, Corina A, Camargo A, Yubero-Serrano EM, Rodriguez-Cantalejo F, Garcia-Rios A, Luque RM, Ordovas JM, Perez-Martinez P, Lopez-Miranda J, Delgado-Lista J. Long-term dietary adherence and changes in dietary intake in coronary patients after intervention with a Mediterranean diet or a low-fat diet: the CORDIOPREV randomized trial. Eur J Nutr. 2020 Aug;59(5):2099-2110. doi: 10.1007/s00394-019-02059-5. Epub 2019 Jul 24.
PubMed 31342228
Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.
PubMed 22905215
Leblanc V, Begin C, Hudon AM, Royer MM, Corneau L, Dodin S, Lemieux S. Effects of a nutritional intervention program based on the self-determination theory and promoting the Mediterranean diet. Health Psychol Open. 2016 Jan 3;3(1):2055102915622094. doi: 10.1177/2055102915622094. eCollection 2016 Jan.
PubMed 28070382
Chakraborty B, Collins LM, Strecher VJ, Murphy SA. Developing multicomponent interventions using fractional factorial designs. Stat Med. 2009 Sep 20;28(21):2687-708. doi: 10.1002/sim.3643.
PubMed 19575485
Harris JL, Romo-Palafox MJ, Gershman H, Kagan I, Duffy V. Healthy Snacks and Drinks for Toddlers: A Qualitative Study of Caregivers' Understanding of Expert Recommendations and Perceived Barriers to Adherence. Nutrients. 2023 Feb 17;15(4):1006. doi: 10.3390/nu15041006.
PubMed 36839364
Black AP, D'Onise K, McDermott R, Vally H, O'Dea K. How effective are family-based and institutional nutrition interventions in improving children's diet and health? A systematic review. BMC Public Health. 2017 Oct 17;17(1):818. doi: 10.1186/s12889-017-4795-5.
PubMed 29041899
Bibiloni MDM, Gallardo-Alfaro L, Gomez SF, Warnberg J, Oses-Recalde M, Gonzalez-Gross M, Gusi N, Aznar S, Marin-Cascales E, Gonzalez-Valeiro MA, Serra-Majem L, Terrados N, Segu M, Lassale C, Homs C, Benavente-Marin JC, Labayen I, Zapico AG, Sanchez-Gomez J, Jimenez-Zazo F, Alcaraz PE, Sevilla-Sanchez M, Herrera-Ramos E, Pulgar S, Sistac C, Schroder H, Bouzas C, Tur JA. Determinants of Adherence to the Mediterranean Diet in Spanish Children and Adolescents: The PASOS Study. Nutrients. 2022 Feb 9;14(4):738. doi: 10.3390/nu14040738.
PubMed 35215388

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks
ClinicalTrials.gov ID: NCT06057324
Acronym / sponsor ID: SWITCHtoHEALTHY
Conditions: Healthy Subjects, Behavior, Health, Family
Keywords: Mediterranean Diet, Adherence, Family, Nutritional intervention, Sustainability, Educational Activities, Healthy Food Choice, Digital Technology
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 480 participants (estimated)
Lead sponsor: Fundació EurecatUniversity, hospital or other
Collaborators: Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA), Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN), Uludag University
Study start: 1 Nov 2023 (actual)
Primary completion: Apr 2025 (estimated)
Study completion: May 2025 (estimated)
First posted: 28 Sep 2023 (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.

Detailed description

The study will be carried out in 2 phases:

Phase 1 (month 0 to month 9): the families will be included in the study, they will be assigned to the different intervention groups, and consumption patterns and lifestyle, diet, and socioeconomic indicators will be evaluated through specific questionnaires. In addition, the different educational materials, activities, digital interactive tools and healthy snacks will be developed prior to the start of the intervention study.
Phase 2 (month 10 to month 13): The intervention study will be deployed at family level. Each family will receive the educational materials, digital interactive tools and snacks developed in Phase 1 as assigned. In addition, anthropometric, lifestyle, dietary and socioeconomic indicators will be evaluated through questionnaires.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Multicentre, parallel, randomized, single-blind and controlled clinical trial

Arm	Type	Receives
Multi-component intervention groups	Experimental	Device: AI-based Apps, Behavioral: Mediterranean-based diet toolkit and activities, Other: Healthy plant-based snacks, Other: AI-based Apps + Mediterranean-based diet toolkit and activities, Other: AI-based Apps + Healthy plant-based snacks, Other: Mediterranean-based diet toolkit and activities + Healthy plant-based snacks, Other: AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacksMulti-component intervention with non-invasive approaches: -Digital interactive tools (AI-based Apps): They will consist of a combination of two Artificial Intelligence (AI) Apps that will be used by parents to empower them in their daily dietary choices for children's dietary plan. - Educational materials (Mediterranean-based diet toolkit) and activities: The toolkit will include a set of specific games and activities for kids designed to facilitate the ''learning through playing'' approach improving their understanding of different nutrition themes. The educational activities will be co-designed and carried out by adolescents outside of school hours. - Healthy plant-based snacks: They will be adapted to children's nutritional requirements and to be consumed in-between time on a daily basis. Based on local and traditional products for each country including vegetables, fruits, legumes, seeds and nuts as main ingredients.
Control group	No intervention	–Families which will not follow any intervention; they will receive basic Mediterranean guidelines for parents and their children.

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Families from any socioeconomic status with at least one child less than 12 years and one adolescent older than or equal to 12 years (overall age range 3 - 17 years) and that live together.
Signed informed consent (parents will sign on their own behalf and of the child under 12 years of age and the adolescent. The adolescent must also sign themselves).
To have a mobile phone, tablet, or computer with internet access.

Key exclusion criteria (8 listed)

Having allergies or food intolerances to any of the snack ingredients: fruit, vegetables, legumes, cereals, seeds, nuts (only for children under 12 years).
Dislike any of the snacks (only for children under 12 years).
Mediterranean Diet Adherence Score (MEDAS) among 8-14 or KIDMED score among 8-12, which is a food pattern already highly concordant with the Mediterranean Diet.
Following a vegan diet any of the family members.
Following a prescribed long-term and strict diet for any reason, including diets for weight loss and diets for chronic metabolic or autoimmune disorders such as type 1 diabetes, celiac disease, inflammatory bowel disease or rheumatoid arthritis (any of the family members).

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
AI-based AppsFamilies which will use the digital interactive tools to empower parents in their daily dietary choices.	Device	Multi-component intervention groups
Mediterranean-based diet toolkit and activitiesFamilies which will receive educational materials and adolescents will perform educational activities.	Behavioural	Multi-component intervention groups
Healthy plant-based snacksFamilies in which children will include the snacks in their diet.	Other	Multi-component intervention groups
AI-based Apps + Mediterranean-based diet toolkit and activitiesFamilies which will use the digital interactive tools and receive educational material, and adolescents will perform educational activities.	Other	Multi-component intervention groups
AI-based Apps + Healthy plant-based snacksFamilies which will use the digital interactive tools and children will include the snacks in their diet.	Other	Multi-component intervention groups
Mediterranean-based diet toolkit and activities + Healthy plant-based snacksFamilies which will receive educational material, adolescents will perform educational activities, and children will include the snacks in their diet.	Other	Multi-component intervention groups
AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacksFamilies which will use the digital interactive tools and will receive educational material, children will include the snacks in their diet, and adolescents will perform educational activities.	Other	Multi-component intervention groups

Primary outcome

Change in adherence to the Mediterranean Diet
Time frame: Phase 2 (month 10 to month 13)
The main outcome will be adherence to the MD measured through MEDAS questionnaire score in parents. The effectiveness of the multi-component intervention will be evaluated by comparing the MEDAS score between the control and intervention groups during the intervention period (Phase 2). The MEDAS score is an extension of a 9-point score developed in the Prevention with Mediterranean Diet (PREDIMED) trial. A score of 14 points means maximum adherence to the Mediterranean Diet while a score below 7 points means low adherence.
Change in adherence to the Mediterranean Diet
Time frame: Phase 2 (month 10 to month 13)
The main outcome will be adherence to the MD measured through KIDMED questionnaire score in children. The effectiveness of the multi-component intervention will be evaluated by comparing the KIDMED score between the control and intervention groups during the intervention period (Phase 2). The KIDMED score ranges from 0 to 12 points, so a score greater than or equal to 8 points means optimal Mediterranean Diet adherence while a score below or equal to 3 points means very low-quality diet, and between 4 and 7 points means that need to improve the eating pattern to fit the Mediterranean pattern.

20 secondary outcomes

Change in Body Mass Index values
Time frame: Phase 2 (month 10 to month 13)
Change in waist circumference values
Time frame: Phase 2 (month 10 to month 13)
Change in blood pressure values
Time frame: Phase 2 (month 10 to month 13)
Change in resting heart rate values
Time frame: Phase 2 (month 10 to month 13)
Sociodemographic and socioeconomic data
Time frame: Phase 1 (baseline)
Social factors data
Time frame: Phase 1 (baseline)
Change in physical activity levels
Time frame: Phase 2 (month 10 to month 13)
Change in physical activity levels
Time frame: Phase 2 (month 10 to month 13)
Change in quality of life
Time frame: Phase 2 (month 10 to month 13)
Change in quality of life
Time frame: Phase 2 (month 10 to month 13)
Change in nutritional knowledge
Time frame: Phase 2 (month 10 to month 13)
Change in nutritional knowledge
Time frame: Phase 2 (month 10 to month 13)
Change in the health factor
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in Mediterranean Diet lifestyle habits
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in diet quality
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in diet quality
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in attitudes and beliefs in relation to food
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in consumption behavior
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in environmental impact
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Change in economic impact
Time frame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)

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 3 Mar 2025.
Background: PubMed 30646500Alonso-Dominguez R, Garcia-Ortiz L, Patino-Alonso MC, Sanchez-Aguadero N, Gomez-Marcos MA, Recio-Rodriguez JI. Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study). Nutrients. 2019 Jan 14;11(1):162. doi: 10.3390/nu11010162.
Background: PubMed 21810282Sichert-Hellert W, Beghin L, De Henauw S, Grammatikaki E, Hallstrom L, Manios Y, Mesana MI, Molnar D, Dietrich S, Piccinelli R, Plada M, Sjostrom M, Moreno LA, Kersting M; HELENA Study Group. Nutritional knowledge in European adolescents: results from the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study. Public Health Nutr. 2011 Dec;14(12):2083-91. doi: 10.1017/S1368980011001352. Epub 2011 Aug 2.
Background: PubMed 21310201Dickson-Spillmann M, Siegrist M, Keller C. Development and validation of a short, consumer-oriented nutrition knowledge questionnaire. Appetite. 2011 Jun;56(3):617-20. doi: 10.1016/j.appet.2011.01.034. Epub 2011 Feb 15.
Background: PubMed 11759336Ravens-Sieberer U, Gosch A, Abel T, Auquier P, Bellach BM, Bruil J, Dur W, Power M, Rajmil L; European KIDSCREEN Group. Quality of life in children and adolescents: a European public health perspective. Soz Praventivmed. 2001;46(5):294-302. doi: 10.1007/BF01321080.
Background: PubMed 26319833Sotos-Prieto M, Santos-Beneit G, Bodega P, Pocock S, Mattei J, Penalvo JL. VALIDATION OF A QUESTIONNAIRE TO MEASURE OVERALL MEDITERRANEAN LIFESTYLE HABITS FOR RESEARCH APPLICATION: THE MEDITERRANEAN LIFESTYLE INDEX (MEDLIFE). Nutr Hosp. 2015 Sep 1;32(3):1153-63. doi: 10.3305/nh.2015.32.3.9387.
Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
Background: PubMed 34090437Rodriguez-Rodriguez F, Galvez-Fernandez P, Huertas-Delgado FJ, Aranda-Balboa MJ, Saucedo-Araujo RG, Herrador-Colmenero M. Parent's sociodemographic factors, physical activity and active commuting are predictors of independent mobility to school. Int J Health Geogr. 2021 Jun 6;20(1):26. doi: 10.1186/s12942-021-00280-2.
Background: PubMed 15482620Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
Background: PubMed 31342228Quintana-Navarro GM, Alcala-Diaz JF, Lopez-Moreno J, Perez-Corral I, Leon-Acuna A, Torres-Pena JD, Rangel-Zuniga OA, Arenas de Larriva AP, Corina A, Camargo A, Yubero-Serrano EM, Rodriguez-Cantalejo F, Garcia-Rios A, Luque RM, Ordovas JM, Perez-Martinez P, Lopez-Miranda J, Delgado-Lista J. Long-term dietary adherence and changes in dietary intake in coronary patients after intervention with a Mediterranean diet or a low-fat diet: the CORDIOPREV randomized trial. Eur J Nutr. 2020 Aug;59(5):2099-2110. doi: 10.1007/s00394-019-02059-5. Epub 2019 Jul 24.
Background: PubMed 22905215Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.
Background: PubMed 28070382Leblanc V, Begin C, Hudon AM, Royer MM, Corneau L, Dodin S, Lemieux S. Effects of a nutritional intervention program based on the self-determination theory and promoting the Mediterranean diet. Health Psychol Open. 2016 Jan 3;3(1):2055102915622094. doi: 10.1177/2055102915622094. eCollection 2016 Jan.
Background: PubMed 19575485Chakraborty B, Collins LM, Strecher VJ, Murphy SA. Developing multicomponent interventions using fractional factorial designs. Stat Med. 2009 Sep 20;28(21):2687-708. doi: 10.1002/sim.3643.
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.

Antoni Caimari Palou, PhD principal investigator

Fundació Eurecat

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: enrolling by invitation, as of the sponsor's last update on 3 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in adherence to the Mediterranean Diet (time frame: Phase 2 (month 10 to month 13)). The study lists 2 primary outcomes in all. 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 NCT06057324, which also lists 22 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 3 Mar 2025.