A Multidisciplinary Weight Loss Program at AUB-MC

NCT ID: NCT04194424

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2026-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multidisciplinary program

Multidisciplinary weight loss program

Group Type EXPERIMENTAL

Multidisciplinary weight loss program

Intervention Type OTHER

Diet and behavioral therapy,and supervised exercise sessions

Metformin Hcl 850Mg Tab

Intervention Type DRUG

1 tablet, twice daily

Control

Standard care

Group Type OTHER

Standard Care

Intervention Type OTHER

General lifestyle tips

Metformin Hcl 850Mg Tab

Intervention Type DRUG

1 tablet, twice daily

Interventions

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Multidisciplinary weight loss program

Diet and behavioral therapy,and supervised exercise sessions

Intervention Type OTHER

Standard Care

General lifestyle tips

Intervention Type OTHER

Metformin Hcl 850Mg Tab

1 tablet, twice daily

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marlene Chakhtoura

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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American University of Beirut - Medical Center

Beirut, Riad El Solh, Lebanon

Site Status

Countries

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Lebanon

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BIO-2018-0400

Identifier Type: -

Identifier Source: org_study_id

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