The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Virginia
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Henrico、Virginia、美国、23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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;
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:High-Intensity Interval Training
Brief periods of vigorous physical activity separated by short periods of rest.
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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.
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有源比较器:Moderate-Intensity Continuous Training
Physical activity at a sustained moderate heart rate.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cardiorespiratory fitness
大体时间:12 weeks
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The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Body Mass Index (BMI)
大体时间:12 weeks
|
The two training methods will be compared for changes in participants' BMI in kg/m2
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12 weeks
|
Change in Blood Lipid Levels
大体时间:12 weeks
|
The two training methods will be compared for changes in fasting lipid levels.
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12 weeks
|
Change in Body Composition
大体时间:12 weeks
|
The two training methods will be compared for differences in changes of percent body fat.
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12 weeks
|
Participant Attendance
大体时间:12 weeks
|
The two training methods will be compared for differences in rates of participant attendance at intervention sessions.
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12 weeks
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Achievement of Heart Rate Goals.
大体时间:12 weeks
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The two training methods will be compared for differences in rates of achievement of heart rate goals during exercise training sessions.
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12 weeks
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Acceptability of exercise
大体时间:12 weeks
|
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
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12 weeks
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Feasibility of Exercise
大体时间:12 weeks
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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.
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12 weeks
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Maintenance of lifestyle changes
大体时间:16 weeks
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The two training methods will be compared for participants' frequency of participation in physical activity 1 month after completion of the intervention.
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16 weeks
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Weight loss maintenance
大体时间:16 weeks.
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The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
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16 weeks.
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合作者和调查者
调查人员
- 首席研究员:Edmond P Wickham, MD、VCU Departments of Pediatrics and Internal Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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