AUB-MC での学際的な減量プログラム
AUB-MC での学際的な減量プログラム: オープン ラベル パイロットのランダム化比較試験
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Riad El Solh
-
Beirut、Riad El Solh、レバノン、1107 2020
- American University of Beirut - Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Multidisciplinary program
Multidisciplinary weight loss program |
Diet and behavioral therapy,and supervised exercise sessions 1 tablet, twice daily |
|
他の：Control
Standard care |
1 tablet, twice daily General lifestyle tips |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean percent weight loss per treatment arm
時間枠：6 months after enrollment
|
[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100 |
6 months after enrollment
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in weight
時間枠：6 months after enrollment
|
TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg |
6 months after enrollment
|
|
Change in BMI
時間枠：6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight. |
6 months after enrollment
|
|
Change in body composition
時間枠：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) |
6 months after enrollment
|
|
basal metabolic rate (BMR)
時間枠：6 months after enrollment
|
TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR |
6 months after enrollment
|
|
Change in physical fitness (distance)
時間枠：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 months after enrollment
|
|
Change in resting blood pressure before and after physical exercise
時間枠：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 |
6 months after enrollment
|
|
Change in oxygen saturation before and after physical exercise
時間枠：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 |
6 months after enrollment
|
|
Change in heart rate before and after physical exercise
時間枠：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. |
6 months after enrollment
|
|
Change in physical fitness (Perceived Exertion)
時間枠：6 months after enrollment
|
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
時間枠：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. |
6 months after enrollment
|
|
Change in levels of Mineral markers and hormones (cross laps)
時間枠：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. |
6 months after enrollment
|
|
Change in levels of Mineral markers and hormones (Osteocalcin)
時間枠：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. |
6 months after enrollment
|
|
Participants' compliance
時間枠：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 |
6 months after enrollment
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BIO-2018-0400
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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