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MORPH-A - Multidisciplinary Obesity Rehabilitation & Psychophysical Health and Awareness

Sponsor: Istituti Clinici Scientifici Maugeri SpA • ClinicalTrials.gov ID: NCT07880847

Registry updated: 2026-10-19

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Description

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.

Interventions

MAC Mutiltidisciplinary Rehabilitation Program (Other)
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 Management (Other)
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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Obesity

Locations

Istituti Clinici Scientifici Maugeri, IRCCS — Pavia, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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