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Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens

2015年7月7日 更新者:Lori Pbert、University of Massachusetts, Worcester
This project will compare the preliminary efficacy of a novel school-delivered intervention, mindfulness plus health education intervention, to health education alone on dietary and physical activity habits in adolescents. This study has important public health implications because of the negative consequences of unhealthy diets and lack of exercise on health, such as obesity, cardiovascular disease and diabetes. If effective, this intervention has high potential for translation to high school settings

研究概览

地位

完全的

条件

详细说明

Unhealthy dietary habits and physical inactivity are important modifiable behavioral risk factors for the development of cardiovascular disease. Both behaviors are often established during adolescence and are highly prevalent in teenagers. Conversely, the establishment of healthy dietary and physical activity habits in youth leads to significant health benefits in adulthood, highlighting the need to develop programs aimed at improving dietary and physical activity habits in youth. However, thus far, interventions designed to promote healthy dietary and exercise habits in adolescents have had modest effects on these behaviors, and there is limited knowledge on how to maintain positive changes in these habits over time. Current evidence from observational studies suggests that higher mindfulness levels in adolescents are associated with better eating and exercise habits. In addition, mindfulness is associated with lower impulsivity and better self-control, which are important determinants of healthy behaviors in younger populations. Multiple studies have shown that mindfulness levels increase in response to mindfulness training, and that an increase in mindfulness mediates the effect of mindfulness interventions on health outcomes. Consistent with the goals of PA-11-329 "to determine the influence of complementary and alternative medicine approaches on developing and sustaining healthy behavior habits in children and youth" this multi-PI application seeks to study the role of mindfulness training in promoting and maintaining healthy dietary and physical activity habits. We posit that the addition of mindfulness training to an educational program, compared to an educational program alone, will improve diet and physical activity, and these changes will be maintained over time. In addition, we expect to observe a decrease in impulsivity, indicating that impulsivity may serve as a potential mediator of the effect of the mindfulness intervention on diet and physical activity. This pilot study will test the feasibility and preliminary efficacy of a school-delivered, mindfulness + health education intervention (MHE) compared to health education (HE) alone on dietary habits and physical activity in 80 adolescents recruited among 9th graders (average age, 14) in 2 high schools in Massachusetts; each school will be randomized to either the MHE or HE intervention. Assessments will be performed at baseline, at the end of the intervention (2 months post-baseline), and at 8- months (end of academic year) follow-up. Innovative aspects of this proposal include studying the effect of mindfulness training on health behaviors among youth and the development of a new model linking mindfulness, impulsivity and behavioral change in this population. The study is significant due to the importance of the behaviors targeted and to the potential for translation to high school settings if an effect is demonstrated.

研究类型

介入性

注册 (实际的)

53

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

    • Massachusetts
      • Worcester、Massachusetts、美国、01655
        • University of Massachusetts Medical School

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 15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:

  • Inclusion criteria: (1) enrolled in 9th grade, (2) no prior mindfulness training; (3) English-speaking with at least one English-speaking parent/guardian.

Exclusion Criteria:

  • Exclusion Criteria: (1) planning to move out of the area within the next 8 months, (2) unable or unwilling to provide informed assent (adolescent) and parental consent, (3) diagnosis of a serious psychiatric illness during the past 5 years (4) developmental delay that would prevent study participation.

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:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Meditation
The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own
The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own
无干预:Health Education
The health education curriculum will be informed by: 1) the dietary and PA didactic units and materials developed as part of our school based trial, adapted for adolescents from the Diabetes Prevention Program (DPP) and 2) the standard curricula for school-based health education programs with particular attention to the unique needs of adolescents:increasing fruits and vegetables, reducing sugar sweetened drinks, and decreasing foods high in fat, unhealthy carbohydrates, and calories. The PA component will be based on current recommendations of engaging in at least 1 hour of moderate-to-vigorous physical activity (MVPA) most days of the week, building PA into the teen's lifestyle,and reducing sedentary behavior.

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
Feasibility of the Intervention
大体时间:One academic year, 8 months
We will be able to recruit 80 adolescents (40 per condition) within the specified time frame, and no more than 20% will drop out of the study.
One academic year, 8 months
Acceptability of Intervention
大体时间:One academic year, 8 months
Program evaluations for both conditions will show overall positive comments and at least 80% of participants will indicate high acceptability ratings.
One academic year, 8 months

次要结果测量

结果测量
措施说明
大体时间
Preliminary estimates of efficacy
大体时间:One academic year, 8 months
The MHE group, compared to HE, will have greater changes in calorie, saturated fat intake and fruit and vegetable intake, and in physical activity at the end of intervention; these changes will be maintained over time (8-month follow-up). Additional outcomes will include BMI, sedentary behavior, and quality of life.
One academic year, 8 months
Explore possible mechanisms of the effect of MHE on diet and physical activity
大体时间:One academic year, 8 months
The MHE intervention, compared to HE, will increase mindfulness; higher mindfulness will be associated with a decrease in impulsivity; and the decrease in impulsivity will be positively associated with changes in diet and physical activity.
One academic year, 8 months

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:Elena Salmoirago-Blotcher, PhD, MD、Brown University, Providence, RI

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

2014年9月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2013年10月28日

首先提交符合 QC 标准的

2013年10月29日

首次发布 (估计)

2013年11月5日

研究记录更新

最后更新发布 (估计)

2015年7月8日

上次提交的符合 QC 标准的更新

2015年7月7日

最后验证

2015年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R21H119665

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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