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The Role of High Intensity Interval Training in the Treatment of Adolescent Obesity

2021年4月5日 更新者:Virginia Commonwealth University
The study will compare the effects of High Intensity Interval Training (HIIT) with Moderate Intensity Continuous Training (CMIT) as part of a lifestyle intervention program on BMI change in adolescents age 12-16 with obesity.

研究概览

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

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Virginia
      • Henrico、Virginia、美国、23239
        • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 16年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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.
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.
有源比较器: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.

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
The two training methods will be compared for how they impact participants' fitness levels as assessed during a graded exercise tolerance test.
12 weeks

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
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.
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.
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.
12 weeks
Achievement of Heart Rate Goals.
大体时间: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
大体时间:12 weeks
The two training methods will be compared for differences in participants' reported enjoyment of the exercise session.
12 weeks
Feasibility of Exercise
大体时间: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
大体时间: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
大体时间:16 weeks.
The two training methods will be compared for changes in BMI 1 month after completion of the intervention.
16 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月8日

初级完成 (实际的)

2020年1月13日

研究完成 (实际的)

2020年2月20日

研究注册日期

首次提交

2017年11月17日

首先提交符合 QC 标准的

2017年11月28日

首次发布 (实际的)

2017年12月5日

研究记录更新

最后更新发布 (实际的)

2021年4月8日

上次提交的符合 QC 标准的更新

2021年4月5日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • HM20010365
  • R21HD090448 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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