An interventional study of MAC Mutiltidisciplinary Rehabilitation Program and Routine Clinical and Care Management in Obesity, sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Treatment
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.
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:
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 34 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 117 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Multidisciplinary Rehabilitation Program
Other: MAC Mutiltidisciplinary Rehabilitation Program
Routine Clinical and Care Management (less structured activities)
Other: Routine Clinical and Care Management
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).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0) and post training (12-weeks, T1)
Age of participants
mean age of participants
Time frame: Baseline (T0)
Sex distribution of participants
Number and percentage of patients by sex
Time frame: Baseline (T0)
Education level
years of formal education completed by patients
Time frame: Baseline (T0)
Clinical and lifestyle characteristics
Number and percentage of participants presenting comorbidities, regular physical activity, tobacco use, alcohol consumption, current medical therapy, etc.
Time frame: Baseline (T0)
Waist circumference
measured in cm
Time frame: 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)
Time frame: Baseline (T0), post training (12-weeks, T1), and at 6 months follow-up (T2)
Started Aug 2026 (actual). Primary completion is estimated for May 2028, 21 months after the start.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 21 months is below that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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