The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
調査の概要
状態
詳細な説明
Adolescents will be randomized to a 12-week lifestyle intervention including behavioral and dietary interventions, and one of two exercise training conditions, HIIT or CMIT). Adolescents in the HIIT treatment will participate in treadmill exercise in 1-minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study. Adolescents in the CMIT treatment will participate in a constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study.
Both parents and teens will have height and weight measurements taken, complete behavior questionnaires and wear an activity monitor for one week at baseline, 12 weeks and 16 weeks.
Adolescents will have a physical exam by a study medical provider before starting the intervention. Adolescents will also have blood work, an oral glucose tolerance test, an electrocardiogram, body composition measurements and a maximal graded exercise test done at baseline, and again at one or more time points. Adolescents will also complete a detailed food log at those time points.
Adolescents will exercise at the study gym 3 evenings a week for 12 weeks. On one of those evenings teens will also attend a 60-minute individual behavioral weight management session. Nine of these are with a behavior coach, and 3 with a dietitian. Parents will also attend one introductory session with the behavior coach, join the teen for the 3 sessions with the dietitian, and review adolescent individual goals and identify parent support goals at the end of each behavior session.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Virginia
-
Henrico、Virginia、アメリカ、23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles 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:
- Age of 12 to 16 years with obesity (BMI ≥95% percentile for age and gender according to the CDC Growth Charts).
- Have a parent (or legal guardian) who is willing to provide basic demographic information, complete required surveys, and attend portions of the weekly adolescent-focused behavioral weight management sessions.
- Participating parent must reside with the adolescent within a 30-mile distance of the study site.
Exclusion Criteria:
- Non-English speaking;
- Weight >300 lbs;
- Medical condition(s) that may be associated with unintentional weight change (e.g., hypothalamic injury, Prader-Willi, untreated thyroid disease or malignancy);
- Diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with glucose intolerance or "prediabetes" will eligible for study participation);
- Use of insulin sensitizing agents (e.g. metformin), antihypertensive medications, medications for treatment of hyperlipidemia, oral contraceptives, oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
- Medical condition(s) that may be negatively impacted by high-intensity exercise training;
- Psychiatric, cognitive, developmental or physical conditions that would impair the adolescent's ability to complete assessments, participate in behavioral weight management sessions, or conduct physical activity;
- Reports of compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3 months;
- Current pregnancy or plan to become pregnant during study period;
- Previous participation in the TEENS study at Virginia Commonwealth University;
- Current participation in another weight loss program; or
- Personal history of weight loss surgery;
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：High-Intensity Interval Training
Brief periods of vigorous physical activity separated by short periods of rest.
|
Participants assigned to HIIT will participate in treadmill exercise in intervals consisting of 1 minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study.
|
|
アクティブコンパレータ：Moderate-Intensity Continuous Training
Physical activity at a sustained moderate heart rate.
|
Participants assigned to CMIT will participate in constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study.
|
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 |
|---|---|---|
|
Cardiorespiratory fitness
時間枠：12 weeks
|
The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Mass Index (BMI)
時間枠：12 weeks
|
The two training methods will be compared for changes in participants' BMI in kg/m2
|
12 weeks
|
|
Change in Blood Lipid Levels
時間枠：12 weeks
|
The two training methods will be compared for changes in fasting lipid levels.
|
12 weeks
|
|
Change in Body Composition
時間枠：12 weeks
|
The two training methods will be compared for differences in changes of percent body fat.
|
12 weeks
|
|
Participant Attendance
時間枠：12 weeks
|
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
|
12 weeks
|
|
Achievement of Heart Rate Goals.
時間枠：12 weeks
|
The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions.
|
12 weeks
|
|
Acceptability of exercise
時間枠：12 weeks
|
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
|
12 weeks
|
|
Feasibility of Exercise
時間枠：12 weeks
|
The two training methods will be compared for differences in participants' confidence in being able ability to continue to participate in the assigned type of exercise.
|
12 weeks
|
|
Maintenance of lifestyle changes
時間枠：16 weeks
|
The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention.
|
16 weeks
|
|
Weight loss maintenance
時間枠：16 weeks.
|
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
|
16 weeks.
|
協力者と研究者
捜査官
- 主任研究者：Edmond P Wickham, MD、VCU Departments of Pediatrics and Internal Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。