Clinical trial NCT04194424: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Mean percent weight loss per treatment arm
timeFrame: 6 months after enrollment
Secondary outcomes:
Other outcomes:
measure: Change in weight
timeFrame: 6 months after enrollment
measure: Change in BMI
timeFrame: 6 months after enrollment
measure: Change in body composition
timeFrame: 6 months after enrollment
measure: basal metabolic rate (BMR)
timeFrame: 6 months after enrollment
measure: Change in physical fitness (distance)
timeFrame: 6 months after enrollment
measure: Change in resting blood pressure before and after physical exercise
timeFrame: 6 months after enrollment
measure: Change in oxygen saturation before and after physical exercise
timeFrame: 6 months after enrollment
measure: Change in heart rate before and after physical exercise
timeFrame: 6 months after enrollment
measure: Change in physical fitness (Perceived Exertion)
timeFrame: 6 months after enrollment
measure: Change in levels of appetite hormones and metabolic markers
timeFrame: 6 months after enrollment
measure: Change in levels of Mineral markers and hormones (cross laps)
timeFrame: 6 months after enrollment
measure: Change in levels of Mineral markers and hormones (Osteocalcin)
timeFrame: 6 months after enrollment
measure: Participants' compliance
timeFrame: 6 months after enrollment
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
state: Riad El Solh
Study officials:
References: