A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Multidisciplinary weight loss program
- Conditions
- Obesity
- Sponsor
- American University of Beirut Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mean percent weight loss per treatment arm
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Marlene Chakhtoura
Assistant Professor of Medicine
American University of Beirut Medical Center
Eligibility Criteria
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
Arms & Interventions
Multidisciplinary program
Multidisciplinary weight loss program
Intervention: Multidisciplinary weight loss program
Multidisciplinary program
Multidisciplinary weight loss program
Intervention: Metformin Hcl 850Mg Tab
Control
Standard care
Intervention: Standard Care
Control
Standard care
Intervention: Metformin Hcl 850Mg Tab
Outcomes
Primary Outcomes
Mean percent weight loss per treatment arm
Time Frame: 6 months after enrollment
\[(baseline weight-follow up weight at 6 months)/ baseline weight\] X 100