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Eating RePace Study (REPACE)

2015年4月23日 更新者:Children's Hospital of Philadelphia

Eating Pace Retraining in Childhood Obesity Prevention

The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace) to help children at risk for obesity (children who eat rapidly and have an overweight parent/legal guardian) develop a more normal eating rate.

研究概览

详细说明

Childhood obesity is one of nation's foremost public health epidemics, for which more potent and enduring prevention interventions are needed. The goal of this program of research is to study novel methods which may help to prevent childhood obesity. The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. The investigators hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.

As the sample size is relatively small, the aim is to develop an "effect size estimation," i.e., to generate an effect size that will be used to power an extramural grant application. Specifically, the investigators will generate Cohen's D as the effect size estimate, which is calculated as the difference in the group means divided by the pooled standard deviation. Cohen's D is an established quantitative measure for effect size estimation and informing power analysis for study design.

In addition, this study's objective is to develop and pilot a novel family-based eating behavior program for a prevention intervention in at risk children.

研究类型

介入性

注册 (实际的)

28

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia

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

4年 至 7年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Children:

  • Males or females 4 to 7 years of age.
  • Participants (the children) have a body mass index (BMI) for age and sex between the 65th-<96th percentile (thus, the children will not have a BMI at the 97th percentile or more).
  • Parental/guardian permission (informed consent).
  • Have an overweight or obese participating parent/guardian with a BMI of > 27 kg/m2
  • Increased child eating rate as reported on the questionnaire (Child Eating Behavior Questionnaire) by the parent/guardian

Parents:

  • Parent/legal guardian of subject.
  • Age 21 years and above.
  • Have a BMI of > 27 kg/m2.

Exclusion Criteria:

Children:

  • Children who have any developmental, medical, or psychiatric condition which might affect study compliance, as described by parental (caregiver) report.
  • Children who have serious medical conditions or use of medications (e.g., chronic oral steroids, antipsychotic medications) known to affect food intake or body weight, as described by parental report.
  • Children who have food allergies which may influence consumption of test foods, as reported by the parent; any child with reported peanut allergy.
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Parents:

  • Parents/guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:RePace Intervention Group

Re-Pace intervention-five weekly intervention sessions lasting about 1 hour each.

Lab Test Meal-2 test meals 6-8 weeks apart.

The Re-Pace intervention will provide children and parents/caregivers training in strategies to promote slower eating pace and greater awareness of satiety levels. These skill building strategies can be classified as follows: 1) learning to slow eating rate, 2) awareness-raising activities; 3) role play activities; 4) self-monitoring training; 5) goal setting challenges; and 6) parent training. A core strategy for achieving slower eating pace and improved satiety will be to increase fruit and vegetable intake to meet United States Department of Agriculture (USDA) guidelines (www.myplate.gov). There are 5 intervention visits lasting about 1 to 1.25 hours each. See Section 4.3.1 for more details of the Re-Pace intervention.
有源比较器:Usual Care Control Group
One 25 minute education session (week 6) 2 lab test meals 6-8 weeks apart (baseline and week 6)
Following the second test meal session, parents and children will receive a brief (25 minute) instruction on healthy eating using materials from www.ChooseMyPlate.gov site, including "What's on Your Plate" and "My Plate for Kids" mini-posters.

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
Reduction of eating rate (mouthfuls/min)
大体时间:6 weeks
The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. We hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.
6 weeks

次要结果测量

结果测量
措施说明
大体时间
Reduction of food consumption
大体时间:6 weeks
Reduce the rate of food consumption (kcal/min) and total kcal intake during the test meals (baseline Lab Meal 1 to Lab Meal 2). We also aim for participants to consume more fruits and vegetables during the test meal (baseline to week 6).
6 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:Robert I Berkowitz, MD、Children's Hospital of Philadelphia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2012年11月1日

初级完成 (实际的)

2014年10月1日

研究完成 (实际的)

2014年10月1日

研究注册日期

首次提交

2014年7月8日

首先提交符合 QC 标准的

2014年7月9日

首次发布 (估计)

2014年7月10日

研究记录更新

最后更新发布 (估计)

2015年4月24日

上次提交的符合 QC 标准的更新

2015年4月23日

最后验证

2015年4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

  • 12-009540

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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