A Multidisciplinary Weight Loss Program at AUB-MC

• Sponsor: American University of Beirut Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04194424
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 53.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Weight Loss	Other: Multidisciplinary weight loss program; Other: Standard Care; Drug: Metformin Hcl 850Mg Tab	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial
• Actual Study Start Date: Jun 17, 2019
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Other: Control Standard care	Other: Standard Care; General lifestyle tips; Drug: Metformin Hcl 850Mg Tab; 1 tablet, twice daily

Outcome Measures

Primary Outcome Measures

1. Mean percent weight loss per treatment arm [6 months after enrollment]

   [(baseline weight-follow up weight at 6 months)/ baseline weight] X 100

Other Outcome Measures

1. Change in weight [6 months after enrollment]

   TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg

2. Change in BMI [6 months after enrollment]

   TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight.

3. Change in body composition [6 months after enrollment]

   TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg)

4. basal metabolic rate (BMR) [6 months after enrollment]

   TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR

5. Change in physical fitness (distance) [6 months after enrollment]

   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. Change in resting blood pressure before and after physical exercise [6 months after enrollment]

   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

7. Change in oxygen saturation before and after physical exercise [6 months after enrollment]

   Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation

8. Change in heart rate before and after physical exercise [6 months after enrollment]

   Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate.

9. Change in physical fitness (Perceived Exertion) [6 months after enrollment]

   Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered.

10. Change in levels of appetite hormones and metabolic markers [6 months after enrollment]

    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.

11. Change in levels of Mineral markers and hormones (cross laps) [6 months after enrollment]

    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.

12. Change in levels of Mineral markers and hormones (Osteocalcin) [6 months after enrollment]

    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.

13. Participants' compliance [6 months after enrollment]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American University of Beirut - Medical Center	Beirut	Riad El Solh	Lebanon	1107 2020

Sponsors and Collaborators

• American University of Beirut Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 17, 2019

More Information

Publications

None provided.

• Responsible Party: Marlene Chakhtoura, Assistant Professor of Medicine, American University of Beirut Medical Center
• ClinicalTrials.gov Identifier: NCT04194424
• Other Study ID Numbers: BIO-2018-0400
• First Posted: Dec 11, 2019
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• 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
• Additional relevant MeSH terms: Body Weight; Weight Loss; Metformin

Study Results

No Results Posted as of Aug 9, 2022