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A Multidisciplinary Weight Loss Program at AUB-MC

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Multidisciplinary weight loss program
Standard Care
Metformin Hcl 850Mg Tab
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • American University of Beirut - Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Multidisciplinary program

Control

Arm Description

Multidisciplinary weight loss program

Standard care

Outcomes

Primary Outcome Measures

Mean percent weight loss per treatment arm
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100

Secondary Outcome Measures

Full Information

First Posted
July 18, 2019
Last Updated
August 8, 2022
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04194424
Brief Title
A Multidisciplinary Weight Loss Program at AUB-MC
Official Title
A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary program
Arm Type
Experimental
Arm Description
Multidisciplinary weight loss program
Arm Title
Control
Arm Type
Other
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Multidisciplinary weight loss program
Intervention Description
Diet and behavioral therapy,and supervised exercise sessions
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
General lifestyle tips
Intervention Type
Drug
Intervention Name(s)
Metformin Hcl 850Mg Tab
Intervention Description
1 tablet, twice daily
Primary Outcome Measure Information:
Title
Mean percent weight loss per treatment arm
Description
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100
Time Frame
6 months after enrollment
Other Pre-specified Outcome Measures:
Title
Change in weight
Description
TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg
Time Frame
6 months after enrollment
Title
Change in BMI
Description
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight.
Time Frame
6 months after enrollment
Title
Change in body composition
Description
TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg)
Time Frame
6 months after enrollment
Title
basal metabolic rate (BMR)
Description
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR
Time Frame
6 months after enrollment
Title
Change in physical fitness (distance)
Description
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
Time Frame
6 months after enrollment
Title
Change in resting blood pressure before and after physical exercise
Description
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
Time Frame
6 months after enrollment
Title
Change in oxygen saturation before and after physical exercise
Description
Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation
Time Frame
6 months after enrollment
Title
Change in heart rate before and after physical exercise
Description
Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate.
Time Frame
6 months after enrollment
Title
Change in physical fitness (Perceived Exertion)
Description
Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered.
Time Frame
6 months after enrollment
Title
Change in levels of appetite hormones and metabolic markers
Description
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.
Time Frame
6 months after enrollment
Title
Change in levels of Mineral markers and hormones (cross laps)
Description
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.
Time Frame
6 months after enrollment
Title
Change in levels of Mineral markers and hormones (Osteocalcin)
Description
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.
Time Frame
6 months after enrollment
Title
Participants' compliance
Description
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
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlene Chakhtoura, MD, MSc
Phone
+9611350000
Ext
7411
Email
mc39@aub.edu.lb
Facility Information:
Facility Name
American University of Beirut - Medical Center
City
Beirut
State/Province
Riad El Solh
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AUBMC
Phone
+961350000
Email
aubmc@aub.edu.lb
First Name & Middle Initial & Last Name & Degree
Marlene Chakhtoura, MD, MSc

12. IPD Sharing Statement

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A Multidisciplinary Weight Loss Program at AUB-MC

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