A Multidisciplinary Weight Loss Program at AUB-MC

Study Overview
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Brief Summary
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The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the American University of Beirut Medical Center (AUB-MC). Such intervention is expected to enhance patients' compliance and adherence to lifestyle changes. In addition, the program includes supervised exercise sessions and behavioral therapy. Therefore, our project proposes an evidence based approach to close the obesity treatment gaps.

Official Title
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A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial

Conditions
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Weight Loss, Obesity

Intervention / Treatment
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* Other: Multidisciplinary weight loss program
* Other: Standard Care
* Drug: Metformin Hcl 850Mg Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lebanese adult with obesity (≥18 years), obesity being defined as BMI ≥ 30 kg/m2 Patients who can commit to frequent visit trials as per study protocol Patients not traveling outside Lebanon for at least the 6-month period of the trial Patients tolerating Metformin after a run-in period of 2 weeks Exclusion Criteria: Patients who have taken other weight reducing drug therapy in the previous 6 months Patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near future (at < 6 months) Patients with diabetes Patients working at AUB-MC, as we will not be able to assess the adherence to study visits nor the feasibility of such a program in the general population, presenting to AUB-MC only for clinical care A family member of a patient already enrolled in the study, as the participants will not be independent Pregnant obese patients Patients with pacemakers Patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or psychiatric illnesses History of any surgery of less than 6 weeks duration Patients known to have disabling osteoarthritic or orthopedic problems Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary program<br>Multidisciplinary weight loss program | Other: Multidisciplinary weight loss program<br>* Diet and behavioral therapy,and supervised exercise sessions<br>Drug: Metformin Hcl 850Mg Tab<br>* 1 tablet, twice daily<br>|
| Other: Control<br>Standard care | Other: Standard Care<br>* General lifestyle tips<br>Drug: Metformin Hcl 850Mg Tab<br>* 1 tablet, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent weight loss per treatment arm | [(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 | 6 months after enrollment |