Obesity, Weight Loss
Conditions
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.
Interventions
OTHERMultidisciplinary weight loss program
Diet and behavioral therapy,and supervised exercise sessions
OTHERStandard Care
General lifestyle tips
1 tablet, twice daily
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent weight loss per treatment arm | 6 months after enrollment | \[(baseline weight-follow up weight at 6 months)/ baseline weight\] X 100 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | 6 months after enrollment | TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m\^2) by combining the height and weight. |
| Change in body composition | 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) |
| basal metabolic rate (BMR) | 6 months after enrollment | TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR |
| Change in physical fitness (distance) | 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 |
| Change in resting blood pressure before and after physical exercise | 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 |
| Change in oxygen saturation before and after physical exercise | 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 |
| Change in weight | 6 months after enrollment | TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg |
| Change in physical fitness (Perceived Exertion) | 6 months after enrollment | Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered. |
| Change in levels of appetite hormones and metabolic markers | 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. |
| Change in levels of Mineral markers and hormones (cross laps) | 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. |
| Change in levels of Mineral markers and hormones (Osteocalcin) | 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. |
| Participants' compliance | 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 |
| Change in heart rate before and after physical exercise | 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. |
Countries
Lebanon
Outcome results
None listed