ObesityMORPH-ANCT07880847
MORPH-A - Multidisciplinary Obesity Rehabilitation & Psychophysical Health and Awareness
A study testing MAC Mutiltidisciplinary Rehabilitation Program and Routine Clinical and Care Management in people with Obesity, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Obesity is a multifactorial chronic disease whose prevalence is steadily increasing worldwide, with substantial clinical, functional, psychological, and economic consequences. Body mass index (BMI) and staging systems such as the Edmonton Obesity Staging System (EOSS) allow obesity severity and associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- MAC Mutiltidisciplinary Rehabilitation Program and Routine Clinical and Care Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 25 Aug 2026to 30 Nov 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Class I or II obesity assessed at T0 with comorbid risk factors (EOSS > or equal to 2) for which an SIO appropriateness form with a score > or equal to 20 has been completed
- Patients who agree to begin treatment with a GLP-1 or GLP-1/GIP analog
- Fit for physical exercise
- Willingness to participate in the 12-week program
- Understanding of the Italian language and ability to complete the questionnaires
- Understanding of the research objectives and ability to provide informed consent.
Who cannot join
- Age < 18 years;
- Non-Italian education, illiteracy, or relapse into illiteracy;
- Low motivation/interest or refusal to undergo assessment;
- Absence of comorbidities (EOSS < or equal to 1)
- Major psychiatric disorders, substance abuse;
- Obesity secondary to genetic and endocrinological disorders (e.g., hypercortisolism, acromegaly, overt hypothyroidism);
- Functional limitations that prevent participation in physical therapy sessions;
- Concurrent participation in other trials that could potentially interfere with the outcomes of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri, IRCCS
Pavia, 27100
Antonia Pierobon, +390385247255, antonia.pierobon@icsmaugeri.it
Giulia Cogni, +390382592698, giulia.cogni@icsmaugeri.it
About this study
Official title: MORPH-A - Multidisciplinary Obesity Rehabilitation & Psychophysical Health and Awareness. A Multidisciplinary Outpatient Rehabilitation Programme for Obese Patients With Comorbidities
Obesity is a multifactorial chronic disease whose prevalence is steadily increasing worldwide, with substantial clinical, functional, psychological, and economic consequences. Body mass index (BMI) and staging systems such as the Edmonton Obesity Staging System (EOSS) allow obesity severity and associated cardiometabolic risk to be assessed, but they do not fully capture the complexity of the condition.
Although its etiology is not yet fully understood, obesity results from the interaction of multiple factors. Individual susceptibility, including a hereditary component, interacts with psychobehavioral factors such as dysfunctional eating patterns and sedentary behavior, endocrine disorders in some cases, and broader sociocultural and environmental determinants, including socioeconomic status and lifestyle. This etiological complexity is reflected in the wide-ranging impact of obesity on health: in addition to increasing the risk of numerous clinical complications, obesity can substantially affect psychosocial well-being and quality of life.
Given this multifactorial nature, current evidence and clinical guidelines support interventions that move beyond unidimensional approaches and address multiple dimensions of the condition in an integrated manner. The present study aims to evaluate the efficacy of an integrated multidisciplinary approach to obesity management compared with usual clinical care. The study hypothesis is that the combination of personalized nutritional, physiotherapeutic, and psychotherapeutic interventions can promote greater and more sustained weight loss, as well as better psycho-physiological outcomes.
Read the detailed description
Obesity is recognized worldwide as a major public health concern and is currently regarded as a chronic, complex, and multifactorial disease characterized by excessive adiposity that can impair health. Its prevalence has increased substantially over recent decades: its prevalence has more than doubled since 1980, and in 2014 over 600 million adults worldwide were estimated to be obese.
Body mass index (BMI) remains the most widely used measure for the screening and classification of overweight and obesity in adults. According to World Health Organization criteria, a BMI below 18.5 kg/m² is classified as underweight, 18.5-24.9 kg/m² as normal weight, and 25.0-29.9 kg/m² as overweight. Obesity is defined by a BMI of at least 30 kg/m² and is conventionally classified according to increasing severity as Class I (30.0-34.9 kg/m²), Class II (35.0-39.9 kg/m²), and Class III (≥40 kg/m²).
The etiology of obesity is genuinely multifactorial. Contributing factors include a substantial hereditary component, psychobehavioral factors (dysfunctional eating habits, sedentary behavior), occasional endocrine dysfunctions, and broader sociocultural and environmental determinants (socioeconomic status, early nutritional exposures, gut microbiota). The clinical consequences are numerous and severe: obesity increases the risk of cardiovascular disease, type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, osteoarticular disorders, and certain cancers, while also exposing affected individuals to discrimination and social stigma, with a direct impact on quality of life.
Given this complexity, contemporary clinical guidelines support a comprehensive and individualized approach to obesity management rather than strategies targeting a single determinant. Multicomponent interventions may integrate nutritional therapy, structured physical activity, and psychological and behavioral support, with the aim of improving not only body weight but also metabolic health, physical function, psychological well-being, and the adoption of sustainable health behaviors.
The present project is an interventional, multicenter study with a matched-pairs design aimed at evaluating the efficacy of a 12-week multidisciplinary outpatient rehabilitation program for adults with Class I or Class II obesity and associated comorbidities, compared with routine clinical care.
The primary hypothesis is that an integrated multidisciplinary intervention combining personalized nutritional, physiotherapeutic, and psychotherapeutic treatment will produce greater weight loss than routine clinical care. In addition, the intervention is expected to improve participants' metabolic profile, physical function, eating-related knowledge and behaviors, psychological well-being, and quality of life. The rationale underlying the intervention is that, because obesity is a multidimensional chronic condition, its management may benefit from the coordinated involvement of professionals addressing nutritional, physical, and psychological determinants within a single structured treatment pathway.
The present study has four main objectives:
- To assess changes in body weight, metabolic parameters, and obesity-related clinical severity following the intervention and to compare these changes with those observed in the control group.
- To examine changes in nutritional knowledge, awareness of eating patterns, and health-oriented dietary behaviors, as well as their relationship with treatment adherence and weight outcomes.
- To evaluate changes in quality of life, psychological well-being, anxiety and depressive symptoms, and self-efficacy, and to investigate how these variables relate to treatment outcomes.
- To assess changes in physical function, muscular strength, endurance, and body awareness over the course of treatment and to examine their relationship with overall improvements in health and well-being.
- Conditions
- Obesity
- Being tested
- MAC Mutiltidisciplinary Rehabilitation Program, Routine Clinical and Care Management
- Keywords
- Obesity, Multidisciplinary Rehabilitation, Outpatient Care, Nutritional Awareness, Physical Therapy, Nutritional Intervention, Psychotherapeutic Intervention, Psychological Well-being, Adherence
- Medical subject headings
- Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAC Mutiltidisciplinary Rehabilitation ProgramOther
The rehabilitation program for the experimental group consists of a 12-week multidisciplinary outpatient course, with one 90-minute session per week. The team includes a medical specialist, dietitian/nutritionist, physical therapist, psychologist/psychotherapist, and nurse. Each session includes 30-60 minutes of nutritional intervention (during which nutritional status is assessed, a personalized meal plan is developed, nutrition education is provided, and progress is monitored); 0-30 minutes of psychological intervention (including emotional and motivational support, strategies for eating behaviors managment and emotion regulation); and 30 minutes of physiotherapy (based on functional assessment and a progressively adapted program of aerobic, strength, flexibility, and body-awareness exercises aimed at reducing pain and improving functional independence).
Routine Clinical and Care ManagementOther
Participants in the control group will be managed according to standard clinical and care protocols, including periodic specialist visits (covering both pharmacological and non-pharmacological interventions), printed educational materials on non-pharmacological interventions (physical therapy, dietary, and psychological), without structured access to the MAC program, but with monitoring and data collection via a structured diary of the non-pharmacological interventions performed.
| Study group | Role | What they receive |
|---|---|---|
| MAC Multidisciplinary Rehabilitation Program | Experimental | Multidisciplinary Rehabilitation Program Receives: Other: MAC Mutiltidisciplinary Rehabilitation Program |
| Routine Clinical and Care Management | Active comparator | Routine Clinical and Care Management (less structured activities) Receives: Other: Routine Clinical and Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Obesity Staging System (EOSS)
It is a clinical system that classifies obesity based on its impact on physical, mental, and functional health. It includes five stages (0-4) that reflect the severity of obesity-related conditions.
Measured: Baseline (T0) and post training (12-weeks, T1)
Moynihan's Food Knowledge Questionnaire
It is a tool that measures how much people know about the principles of healthy nutrition, the nutritional composition of various types of foods, their macronutrients, and fiber.
Measured: Baseline (T0) and post training (12-weeks, T1)
Handgrip Test
It measures the maximum isometric strength of the upper limb muscles, particularly those of the forearm and hand. The participant is asked to hold their arm in a neutral position, with the forearm flexed at a 90° angle in the mid-range position, and to gradually squeeze a dynamometer with as much force as possible. Force is measured in kilograms.
Measured: Baseline (T0) and post training (12-weeks, T1)
Six-minute Walk Test
It is a functional test that measures the maximum distance a person can cover in six minutes by walking as fast as possible along a flat path. The total distance is measured in meters.
Measured: Baseline (T0) and post training (12-weeks, T1)
Borg CR10 Scale
It is a scale used to measure the subjective perception of fatigue, and pain during physical or work-related activities. The score ranges from 0 (complete rest) to 10 (the greatest effort you have ever experienced in your life).
Measured: Baseline (T0) and post training (12-weeks, T1)
Instrumental Activity of Daily Living (IADL)
It is a scale used to assess a patient's level of independence in basic and instrumental activities of daily living. The maximum score varies by gender: 0-8 for women and 0-5 for men. The higher the score, the greater the level of independence in basic daily instrumental activities.
Measured: Baseline (T0) and post training (12-weeks, T1)
WOMAC Osteoarthritis Index
It is a self-report instrument designed to detect changes in symptoms and limitations in daily activities resulting from osteoarthritis. The scale consists of 24 items, organized into three subscales: pain (5 items), stiffness (2 items), and function (17 items). Each item is rated on a Likert scale from 0 to 4, where 0 indicates the absence of symptoms and 4 represents symptoms or difficulties of high intensity.
Measured: Baseline (T0) and post training (12-weeks, T1)
Basic Activity of Daily Living (BADL)
It is a scale that assesses a patient's independence in performing basic activities of daily living. Total scores range from 0 to 6.
Measured: Baseline (T0) and post training (12-weeks, T1)
Visual Analogue Scale (VAS)
It is used in this protocol in two different ways, with the aim of measuring subjective aspects reported by the patient. The first application, the Pain VAS, provides a visual representation of the intensity of subjective pain. The patient must mark the line to indicate the perceived pain on a 10-cm line, with one end indicating no pain (corresponding to 0) and the other end indicating the worst pain imaginable (corresponding to 10). The second application, the Functional VAS, follows the same structure but is designed to assess the patient's subjective perception of their functional ability. The Functional VAS is also represented by a 10-cm line, where one end (0) indicates "no difficulty / maximum functionality," while the other end (10) indicates "maximum difficulty / lack of functionality."
Measured: Baseline (T0) and post training (12-weeks, T1)
EuroQoL 5D e EuroQoL VAS
These are two scales that examine quality of life. The EuroQoL 5d is a questionnaire consisting of 5 items that can be answered using a 3-point Likert scale ranging from 1 (no problem) to 3 (serious problem). The EuroQoL VAS is a visual analog scale represented by a graduated thermometer, where the temperature corresponds to the perceived quality of life. The scale ranges from 0 (worst possible health condition) to 100 (best possible health condition), and the respondent is asked to estimate their current level of health by marking the temperature that best represents it.
Measured: Baseline (T0) and post training (12-weeks, T1)
Mindful Attention Awareness Scale (MAAS)
It measures dispositional mindfulness, defined as a habitual tendency to maintain open and conscious attention to the experience of the present moment, free from automatic responses and distractions.
Measured: Baseline (T0) and post training (12-weeks, T1)
Generalized Anxiety Disorder (GAD-7)
It is a self-administered questionnaire designed to identify and monitor anxiety symptoms experienced over the past two weeks. Total scores range from 0 to 21. Higher scores indicate more severe anxiety.
Measured: Baseline (T0) and post training (12-weeks, T1)
Patient Health Questionnaire 9 (PHQ-9)
It is a tool used to assess the severity of depressive symptoms over the past two weeks. Total scores range form 0 to 27. Higher scores indicate more severe depression.
Measured: Baseline (T0) and post training (12-weeks, T1)
Three-Factor Eatin Questionnaire, 18 item (TFEQ-R18)
It examines three key dimensions of eating behavior: cognitive restriction (the tendency to voluntarily control food intake to manage weight), uncontrolled eating (the tendency to lose control and overeat in response to internal or environmental cues), and emotional eating (eating in response to negative emotional states). The survey is self-administered, with responses on a Likert scale.
Measured: Baseline (T0) and post training (12-weeks, T1)
Antecedents and Self-efficacy on Adherence (ASonA)
It is designed to estimate the probability of adherence to a given protocol by identifying both behavioral and cognitive antecedents and task-specific self-efficacy. The total score ranges from 0 to 80. Higher scores indicate greater adherence.
Measured: Baseline (T0) and post training (12-weeks, T1)
Clinical Impairment Asessment (CIA)
It quantifies the degree of psychosocial impairment attributable to the thoughts and behaviors typical of eating disorders, as observed over the past four weeks. The total score ranges from 0 to 48. A higher score indicates a more severe impairment.
Measured: Baseline (T0) and post training (12-weeks, T1)
Age of participants
mean age of participants
Measured: Baseline (T0)
Sex distribution of participants
Number and percentage of patients by sex
Measured: Baseline (T0)
Education level
years of formal education completed by patients
Measured: Baseline (T0)
Clinical and lifestyle characteristics
Number and percentage of participants presenting comorbidities, regular physical activity, tobacco use, alcohol consumption, current medical therapy, etc.
Measured: Baseline (T0)
Waist circumference
measured in cm
Measured: Baseline (T0), post training (12-weeks, T1)
Body Mass Index (BMI)
BMI calculated as weight in kilograms divided by height in meters squared (Kg/m2)
Measured: Baseline (T0), post training (12-weeks, T1), and at 6 months follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Aug 2026
- Primary completion31 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Pierobon, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCSGiulia Cogni, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880847
- Sponsor's protocol ID
- 2026-3.11/187
- Acronym
- MORPH-A
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MORPH-A - Multidisciplinary Obesity Rehabilitation & Psychophysical Health and Awareness. A Multidisciplinary Outpatient Rehabilitation Programme for Obese Patients With Comorbidities
- ClinicalTrials.gov ID
- NCT07880847
- Acronym / sponsor ID
- MORPH-A / 2026-3.11/187
- Conditions
- Obesity
- Keywords
- Obesity, Multidisciplinary Rehabilitation, Outpatient Care, Nutritional Awareness, Physical Therapy, Nutritional Intervention, Psychotherapeutic Intervention, Psychological Well-being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 19 Oct 2026 (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.
Obesity is a multifactorial chronic disease whose prevalence is steadily increasing worldwide, with substantial clinical, functional, psychological, and economic consequences. Body mass index (BMI) and staging systems such as the Edmonton Obesity Staging System (EOSS) allow obesity severity and associated cardiometabolic risk to be assessed, but they do not fully capture the complexity of the condition.
Although its etiology is not yet fully understood, obesity results from the interaction of multiple factors. Individual susceptibility, including a hereditary component, interacts with psychobehavioral factors such as dysfunctional eating patterns and sedentary behavior, endocrine disorders in some cases, and broader sociocultural and environmental determinants, including socioeconomic status and lifestyle. This etiological complexity is reflected in the wide-ranging impact of obesity on health: in addition to increasing the risk of numerous clinical complications, obesity can substantially affect psychosocial well-being and quality of life.
Given this multifactorial nature, current evidence and clinical guidelines support interventions that move beyond unidimensional approaches and address multiple dimensions of the condition in an integrated manner. The present study aims to evaluate the efficacy of an integrated multidisciplinary approach to obesity management compared with usual clinical care. The study hypothesis is that the combination of personalized nutritional, physiotherapeutic, and psychotherapeutic interventions can promote greater and more sustained weight loss, as well as better psycho-physiological outcomes.
Detailed description
Obesity is recognized worldwide as a major public health concern and is currently regarded as a chronic, complex, and multifactorial disease characterized by excessive adiposity that can impair health. Its prevalence has increased substantially over recent decades: its prevalence has more than doubled since 1980, and in 2014 over 600 million adults worldwide were estimated to be obese.
Body mass index (BMI) remains the most widely used measure for the screening and classification of overweight and obesity in adults. According to World Health Organization criteria, a BMI below 18.5 kg/m² is classified as underweight, 18.5-24.9 kg/m² as normal weight, and 25.0-29.9 kg/m² as overweight. Obesity is defined by a BMI of at least 30 kg/m² and is conventionally classified according to increasing severity as Class I (30.0-34.9 kg/m²), Class II (35.0-39.9 kg/m²), and Class III (≥40 kg/m²).
The etiology of obesity is genuinely multifactorial. Contributing factors include a substantial hereditary component, psychobehavioral factors (dysfunctional eating habits, sedentary behavior), occasional endocrine dysfunctions, and broader sociocultural and environmental determinants (socioeconomic status, early nutritional exposures, gut microbiota). The clinical consequences are numerous and severe: obesity increases the risk of cardiovascular disease, type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, osteoarticular disorders, and certain cancers, while also exposing affected individuals to discrimination and social stigma, with a direct impact on quality of life.
Given this complexity, contemporary clinical guidelines support a comprehensive and individualized approach to obesity management rather than strategies targeting a single determinant. Multicomponent interventions may integrate nutritional therapy, structured physical activity, and psychological and behavioral support, with the aim of improving not only body weight but also metabolic health, physical function, psychological well-being, and the adoption of sustainable health behaviors.
The present project is an interventional, multicenter study with a matched-pairs design aimed at evaluating the efficacy of a 12-week multidisciplinary outpatient rehabilitation program for adults with Class I or Class II obesity and associated comorbidities, compared with routine clinical care.
The primary hypothesis is that an integrated multidisciplinary intervention combining personalized nutritional, physiotherapeutic, and psychotherapeutic treatment will produce greater weight loss than routine clinical care. In addition, the intervention is expected to improve participants' metabolic profile, physical function, eating-related knowledge and behaviors, psychological well-being, and quality of life. The rationale underlying the intervention is that, because obesity is a multidimensional chronic condition, its management may benefit from the coordinated involvement of professionals addressing nutritional, physical, and psychological determinants within a single structured treatment pathway.
The present study has four main objectives:
- To assess changes in body weight, metabolic parameters, and obesity-related clinical severity following the intervention and to compare these changes with those observed in the control group.
- To examine changes in nutritional knowledge, awareness of eating patterns, and health-oriented dietary behaviors, as well as their relationship with treatment adherence and weight outcomes.
- To evaluate changes in quality of life, psychological well-being, anxiety and depressive symptoms, and self-efficacy, and to investigate how these variables relate to treatment outcomes.
- To assess changes in physical function, muscular strength, endurance, and body awareness over the course of treatment and to examine their relationship with overall improvements in health and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC Multidisciplinary Rehabilitation Program | Experimental | Other: MAC Mutiltidisciplinary Rehabilitation ProgramMultidisciplinary Rehabilitation Program |
| Routine Clinical and Care Management | Active comparator | Other: Routine Clinical and Care ManagementRoutine Clinical and Care Management (less structured activities) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Class I or II obesity assessed at T0 with comorbid risk factors (EOSS > or equal to 2) for which an SIO appropriateness form with a score > or equal to 20 has been completed
- Patients who agree to begin treatment with a GLP-1 or GLP-1/GIP analog
- Fit for physical exercise
- Willingness to participate in the 12-week program
Key exclusion criteria (8 listed)
- Age < 18 years;
- Non-Italian education, illiteracy, or relapse into illiteracy;
- Low motivation/interest or refusal to undergo assessment;
- Absence of comorbidities (EOSS < or equal to 1)
- Major psychiatric disorders, substance abuse;
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 |
|---|---|---|
| MAC Mutiltidisciplinary Rehabilitation ProgramThe rehabilitation program for the experimental group consists of a 12-week multidisciplinary outpatient course, with one 90-minute session per week. The team includes a medical specialist, dietitian/nutritionist, physical therapist, psychologist/psychotherapist, and nurse. Each session includes 30-60 minutes of nutritional intervention (during which nutritional status is assessed, a personalized meal plan is developed, nutrition education is provided, and progress is monitored); 0-30 minutes of psychological intervention (including emotional and motivational support, strategies for eating behaviors managment and emotion regulation); and 30 minutes of physiotherapy (based on functional assessment and a progressively adapted program of aerobic, strength, flexibility, and body-awareness exercises aimed at reducing pain and improving functional independence). | Other | MAC Multidisciplinary Rehabilitation Program |
| Routine Clinical and Care ManagementParticipants in the control group will be managed according to standard clinical and care protocols, including periodic specialist visits (covering both pharmacological and non-pharmacological interventions), printed educational materials on non-pharmacological interventions (physical therapy, dietary, and psychological), without structured access to the MAC program, but with monitoring and data collection via a structured diary of the non-pharmacological interventions performed. | Other | Routine Clinical and Care Management |
Primary outcome
Edmonton Obesity Staging System (EOSS)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a clinical system that classifies obesity based on its impact on physical, mental, and functional health. It includes five stages (0-4) that reflect the severity of obesity-related conditions.
Moynihan's Food Knowledge Questionnaire
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a tool that measures how much people know about the principles of healthy nutrition, the nutritional composition of various types of foods, their macronutrients, and fiber.
Handgrip Test
Time frame: Baseline (T0) and post training (12-weeks, T1)
It measures the maximum isometric strength of the upper limb muscles, particularly those of the forearm and hand. The participant is asked to hold their arm in a neutral position, with the forearm flexed at a 90° angle in the mid-range position, and to gradually squeeze a dynamometer with as much force as possible. Force is measured in kilograms.
Six-minute Walk Test
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a functional test that measures the maximum distance a person can cover in six minutes by walking as fast as possible along a flat path. The total distance is measured in meters.
Borg CR10 Scale
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a scale used to measure the subjective perception of fatigue, and pain during physical or work-related activities. The score ranges from 0 (complete rest) to 10 (the greatest effort you have ever experienced in your life).
Instrumental Activity of Daily Living (IADL)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a scale used to assess a patient's level of independence in basic and instrumental activities of daily living. The maximum score varies by gender: 0-8 for women and 0-5 for men. The higher the score, the greater the level of independence in basic daily instrumental activities.
WOMAC Osteoarthritis Index
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a self-report instrument designed to detect changes in symptoms and limitations in daily activities resulting from osteoarthritis. The scale consists of 24 items, organized into three subscales: pain (5 items), stiffness (2 items), and function (17 items). Each item is rated on a Likert scale from 0 to 4, where 0 indicates the absence of symptoms and 4 represents symptoms or difficulties of high intensity.
Basic Activity of Daily Living (BADL)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a scale that assesses a patient's independence in performing basic activities of daily living. Total scores range from 0 to 6.
Visual Analogue Scale (VAS)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is used in this protocol in two different ways, with the aim of measuring subjective aspects reported by the patient. The first application, the Pain VAS, provides a visual representation of the intensity of subjective pain. The patient must mark the line to indicate the perceived pain on a 10-cm line, with one end indicating no pain (corresponding to 0) and the other end indicating the worst pain imaginable (corresponding to 10). The second application, the Functional VAS, follows the same structure but is designed to assess the patient's subjective perception of their functional ability. The Functional VAS is also represented by a 10-cm line, where one end (0) indicates "no difficulty / maximum functionality," while the other end (10) indicates "maximum difficulty / lack of functionality."
EuroQoL 5D e EuroQoL VAS
Time frame: Baseline (T0) and post training (12-weeks, T1)
These are two scales that examine quality of life. The EuroQoL 5d is a questionnaire consisting of 5 items that can be answered using a 3-point Likert scale ranging from 1 (no problem) to 3 (serious problem). The EuroQoL VAS is a visual analog scale represented by a graduated thermometer, where the temperature corresponds to the perceived quality of life. The scale ranges from 0 (worst possible health condition) to 100 (best possible health condition), and the respondent is asked to estimate their current level of health by marking the temperature that best represents it.
Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It measures dispositional mindfulness, defined as a habitual tendency to maintain open and conscious attention to the experience of the present moment, free from automatic responses and distractions.
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a self-administered questionnaire designed to identify and monitor anxiety symptoms experienced over the past two weeks. Total scores range from 0 to 21. Higher scores indicate more severe anxiety.
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is a tool used to assess the severity of depressive symptoms over the past two weeks. Total scores range form 0 to 27. Higher scores indicate more severe depression.
Three-Factor Eatin Questionnaire, 18 item (TFEQ-R18)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It examines three key dimensions of eating behavior: cognitive restriction (the tendency to voluntarily control food intake to manage weight), uncontrolled eating (the tendency to lose control and overeat in response to internal or environmental cues), and emotional eating (eating in response to negative emotional states). The survey is self-administered, with responses on a Likert scale.
Antecedents and Self-efficacy on Adherence (ASonA)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It is designed to estimate the probability of adherence to a given protocol by identifying both behavioral and cognitive antecedents and task-specific self-efficacy. The total score ranges from 0 to 80. Higher scores indicate greater adherence.
Clinical Impairment Asessment (CIA)
Time frame: Baseline (T0) and post training (12-weeks, T1)
It quantifies the degree of psychosocial impairment attributable to the thoughts and behaviors typical of eating disorders, as observed over the past four weeks. The total score ranges from 0 to 48. A higher score indicates a more severe impairment.
Age of participants
Time frame: Baseline (T0)
mean age of participants
Sex distribution of participants
Time frame: Baseline (T0)
Number and percentage of patients by sex
Education level
Time frame: Baseline (T0)
years of formal education completed by patients
Clinical and lifestyle characteristics
Time frame: Baseline (T0)
Number and percentage of participants presenting comorbidities, regular physical activity, tobacco use, alcohol consumption, current medical therapy, etc.
Waist circumference
Time frame: Baseline (T0), post training (12-weeks, T1)
measured in cm
Body Mass Index (BMI)
Time frame: Baseline (T0), post training (12-weeks, T1), and at 6 months follow-up (T2)
BMI calculated as weight in kilograms divided by height in meters squared (Kg/m2)
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 19 Oct 2026.
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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.
Antonia Pierobon principal investigator
Istituti Clinici Scientifici Maugeri IRCCS
Giulia Cogni principal investigator
Istituti Clinici Scientifici Maugeri IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAC Mutiltidisciplinary Rehabilitation Program and Routine Clinical and Care Management in people with Obesity, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 7 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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 Italy. 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 Antonia Pierobon (+390385247255, antonia.pierobon@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edmonton Obesity Staging System (EOSS) (time frame: Baseline (T0) and post training (12-weeks, T1)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.