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OpenTrials
Active, Not Recruiting

NCT Number: NCT04194424

A Multidisciplinary Weight Loss Program at AUB-MC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut - Medical Center

Beirut, Riad El Solh, 1107 2020, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Multidisciplinary weight loss program

Other

Diet and behavioral therapy,and supervised exercise sessions

Standard care

Other

General lifestyle tips

Metformin Hcl 850Mg Tab

Drug

1 tablet, twice daily

Primary outcomes

  1. Mean percent weight loss per treatment arm

    Time frame: 6 months after enrollment

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

Other outcomes

  1. Change in weight

    Time frame: 6 months after enrollment

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

  2. Change in BMI

    Time frame: 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

    Time frame: 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)

    Time frame: 6 months after enrollment

    TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR

  5. Change in physical fitness (distance)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2019
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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