A Multidisciplinary Weight Loss Program at AUB-MC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Other: Multidisciplinary weight loss program; Drug: Metformin Hcl 850Mg Tab; Other: Standard Care

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlene Chakhtoura, MD, MSc; Phone Number: 7411 +9611350000; Email: mc39@aub.edu.lb

Study Locations

• Lebanon
  • Riad El Solh
    • Beirut, Riad El Solh, Lebanon, 1107 2020
      • Recruiting
      • American University of Beirut - Medical Center
      • Contact: AUBMC; Phone Number: +961350000; Email: aubmc@aub.edu.lb
      • Principal Investigator: Marlene Chakhtoura, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg	6 months after enrollment
Change in BMI	TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight.	6 months after enrollment
Change in body composition	TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg)	6 months after enrollment
basal metabolic rate (BMR)	TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR	6 months after enrollment
Change in physical fitness (distance)	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: distance covered in meters	6 months after enrollment
Change in resting blood pressure before and after physical exercise	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: resting blood pressure	6 months after enrollment
Change in oxygen saturation before and after physical exercise	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation	6 months after enrollment
Change in heart rate before and after physical exercise	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate.	6 months after enrollment
Change in physical fitness (Perceived Exertion)	Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered.	6 months after enrollment
Change in levels of appetite hormones and metabolic markers	At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various hormones and proteins related to appetite and satiety including Gastric inhibitory polypeptide (GIP), Leptin, Glucagon like peptide 1 (GLP1), Irisin, Insulin, Ghrelin, Orexin, IL6 These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.	6 months after enrollment
Change in levels of Mineral markers and hormones (cross laps)	At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Crosslaps (pg/mL). These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.	6 months after enrollment
Change in levels of Mineral markers and hormones (Osteocalcin)	At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Osteocalcin (ng/mL). These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.	6 months after enrollment
Participants' compliance	Adherence to the dietary intervention: [Number of days the dieticians are contacted/ Total number of days] X 100 Adherence to program visits: [Number of visits attended/ Total number of visits] X 100	6 months after enrollment

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: BIO-2018-0400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No