NCT04194424

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
5mo left

Started Aug 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2023Sep 2026

First Submitted

Initial submission to the registry

July 18, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
3.7 years until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

July 18, 2019

Last Update Submit

January 28, 2025

Conditions

ObesityWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Mean percent weight loss per treatment arm

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

    6 months after enrollment

Other Outcomes (13)

  • Change in weight

    6 months after enrollment

  • Change in BMI

    6 months after enrollment

  • Change in body composition

    6 months after enrollment

  • +10 more other outcomes

Study Arms (2)

Multidisciplinary program

EXPERIMENTAL

Multidisciplinary weight loss program

Other: Multidisciplinary weight loss programDrug: Metformin Hcl 850Mg Tab

Control

OTHER

Standard care

Other: Standard CareDrug: Metformin Hcl 850Mg Tab

Interventions

Multidisciplinary weight loss programOTHER

Diet and behavioral therapy,and supervised exercise sessions

Multidisciplinary program
Standard CareOTHER

General lifestyle tips

Control
Metformin Hcl 850Mg TabDRUG

1 tablet, twice daily

ControlMultidisciplinary program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Riad El Solh, 1107 2020, Lebanon

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Standard of CareMetformin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 18, 2019

First Posted

December 11, 2019

Study Start

August 15, 2023

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations

LE(1)