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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary program | Experimental | Multidisciplinary weight loss program |
|
| Control | Other | Standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary weight loss program | Other | Diet and behavioral therapy,and supervised exercise sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent weight loss per treatment arm | [(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 | 6 months after enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg | 6 months after enrollment |
| Change in BMI | TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut - Medical Center | Beirut | Riad El Solh | 1107 2020 | Lebanon |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2019 | Jul 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Other | General lifestyle tips |
|
| Metformin Hcl 850Mg Tab | Drug | 1 tablet, twice daily |
|
| 6 months after enrollment |
| Change in body composition | TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg) | 6 months after enrollment |
| basal metabolic rate (BMR) | TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR | 6 months after enrollment |
| Change in physical fitness (distance) | 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 months after enrollment |
| Change in resting blood pressure before and after physical exercise | 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 | 6 months after enrollment |
| Change in oxygen saturation before and after physical exercise | Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation | 6 months after enrollment |
| Change in heart rate before and after physical exercise | Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate. | 6 months after enrollment |
| Change in physical fitness (Perceived Exertion) | Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered. | 6 months after enrollment |
| Change in levels of appetite hormones and metabolic markers | 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. | 6 months after enrollment |
| Change in levels of Mineral markers and hormones (cross laps) | 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. | 6 months after enrollment |
| Change in levels of Mineral markers and hormones (Osteocalcin) | 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. | 6 months after enrollment |
| Participants' compliance | 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 | 6 months after enrollment |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |