Impact of an Online Behavioral Weight Loss Program
キーワード
概要
説明
This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.
日付
| 最終確認済み: | 11/30/2011 |
| 最初に提出された: | 12/12/2011 |
| 提出された推定登録数: | 12/13/2011 |
| 最初の投稿: | 12/14/2011 |
| 最終更新が送信されました: | 12/13/2011 |
| 最終更新日: | 12/14/2011 |
| 実際の研究開始日: | 09/30/2008 |
| 一次完了予定日: | 11/30/2011 |
| 研究完了予定日: | 11/30/2011 |
状態または病気
介入/治療
Behavioral: online lifestyle counseling and a fortified diet beverage
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Online basic lifestyle counseling (OBLI) Subjects receive one online informational class. | |
| Experimental: Online lifestyle counseling (OLC) Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss. | |
| Experimental: OBLI intervention plus a fortified diet beverage (BEV) Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage. | |
| Experimental: OLC plus fortified diet beverage (BEV) Subjects receive OLC plus diet beverage (BEV). |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Body Mass Index (BMI) of 25 to 40; 2. age 18 to 65 years; 3. blood pressure less than 140 mmHg systolic and 90 mmHg diastolic; 4. caffeine intake 100-400 mg/d; and 5. ability to participate in physical activity for a minimum of 150 min/week. Exclusion Criteria: 1. pregnancy, lactation or actively trying to become pregnant; 2. medical illnesses or medications that could affect body weight; 3. cigarette smokers; 4. weight loss of 10 or more pounds in the last 3 months; 5. fasting blood glucose greater than 126mg/dl; 6. participation in a clinical research study that would conflict with the purpose of the current trial; and 7. other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol. |
結果
主な結果の測定
1. body weight [12 weeks]
二次的な結果の測定
1. DEXA-determined fat mass [12 weeks]
