AUB-MC의 종합 체중 감량 프로그램
AUB-MC의 종합 체중 감량 프로그램: 오픈 라벨 파일럿 무작위 통제 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Riad El Solh
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Beirut, Riad El Solh, 레바논, 1107 2020
- American University of Beirut - Medical Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Multidisciplinary program
Multidisciplinary weight loss program |
Diet and behavioral therapy,and supervised exercise sessions 1 tablet, twice daily |
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다른: Control
Standard care |
1 tablet, twice daily General lifestyle tips |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean percent weight loss per treatment arm
기간: 6 months after enrollment
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[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 |
6 months after enrollment
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in weight
기간: 6 months after enrollment
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TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg |
6 months after enrollment
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Change in BMI
기간: 6 months after enrollment
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TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight. |
6 months after enrollment
|
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Change in body composition
기간: 6 months after enrollment
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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
|
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basal metabolic rate (BMR)
기간: 6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR |
6 months after enrollment
|
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Change in physical fitness (distance)
기간: 6 months after enrollment
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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
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Change in resting blood pressure before and after physical exercise
기간: 6 months after enrollment
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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
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Change in oxygen saturation before and after physical exercise
기간: 6 months after enrollment
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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
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Change in heart rate before and after physical exercise
기간: 6 months after enrollment
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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
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Change in physical fitness (Perceived Exertion)
기간: 6 months after enrollment
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Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered. |
6 months after enrollment
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Change in levels of appetite hormones and metabolic markers
기간: 6 months after enrollment
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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
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Change in levels of Mineral markers and hormones (cross laps)
기간: 6 months after enrollment
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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
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Change in levels of Mineral markers and hormones (Osteocalcin)
기간: 6 months after enrollment
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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
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Participants' compliance
기간: 6 months after enrollment
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- BIO-2018-0400
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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