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A Multidisciplinary Weight Loss Program at AUB-MC

A

American University of Beirut Medical Center

Status

Active, not recruiting

Conditions

Weight Loss
Obesity

Treatments

Drug: Metformin Hcl 850Mg Tab
Other: Multidisciplinary weight loss program
Other: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT04194424
BIO-2018-0400

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Multidisciplinary program
Experimental group
Description:
Multidisciplinary weight loss program
Treatment:
Other: Multidisciplinary weight loss program
Drug: Metformin Hcl 850Mg Tab
Control
Other group
Description:
Standard care
Treatment:
Other: Standard Care
Drug: Metformin Hcl 850Mg Tab

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Marlene Chakhtoura, MD, MSc

Data sourced from clinicaltrials.gov

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