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临床试验/NCT02976636
NCT02976636已完成不适用

Parent Training Program to Improve Outcomes in Childhood Obesity Treatment

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Change in BMI percentile

研究概览

简要总结

The purpose of this application is to evaluate whether a pediatric weight control program that incorporates comprehensive parenting training with behavioral therapy can increase weight loss in children compared to traditional family-based behavioral therapy programs. Since certain parenting styles are associated with greater weight loss during interventions and appear to enhance the impact of key behavioral strategies, adding parenting training to these interventions may increase the overall effectiveness of these programs and increase our ability to help children obtain a healthy weight. This project could result in identifying an improved method of pediatric obesity treatment that provides additional benefits to the growth and development of children via improved self-regulatory behaviors.

详细描述

Authoritative parenting style has been associated with decreased obesity risk in children, increased weight loss during interventions, and can modify the delivery and impact of weight control strategies, making them more effective. At this time, gold-standard treatment for childhood obesity is family-based behavioral therapy (FBT). This treatment relies on behavioral strategies and the use of praise and a positive reinforcement system to change eating and activity behaviors, but does not target other aspects of parenting. Broadening parenting instruction to include effective limit-setting behaviors, parent-child communication, and authoritative parenting may increase parents' confidence and ability to successfully make behavior changes and modify the impact of the behavioral strategies being used. In this application, the investigators propose to test the efficacy of a 20-week weight control program that combines traditional family-based behavioral therapy with comprehensive parenting training (FBT-PT) and compare it to traditional family-based behavioral therapy (FBT). The investigators hypothesize that there will be an additive effect of parenting training such that FBT-PT will have a greater effect on child weight loss (measured by BMI z-score) than traditional FBT. In addition, the investigators will measure parenting style, parenting strategies, behavioral strategies, and child factors (like impulsive behavior and temperament) to better understand the mediators and moderators of weight loss. These measures will be obtained by standard self-report measures and videotape encounters, allowing one to more objectively measure parenting dimensions. Clinical outcomes, like drop-out and acceptability, will also be assessed from the two treatment arms. The purpose of this study is to evaluate the effect of adding a comprehensive parenting training to traditional FBT. If successful, this program will be able to increase our ability to help children successfully lose weight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The assessors will not know which arm of the study each family is in.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the ages of 7 and 12 years old;
  • BMI ≥85th percentile but <100% overweight, so as to limit those children who are morbidly obese and are in need of more intense medical treatment;
  • Children with mothers who are willing to attend 20 weekly group sessions and be randomized to either treatment arm;
  • Have at least one parent who is overweight or obese (BMI≥25); and
  • Parents who speak English at a 5th grade level.

排除标准

  • Children with serious medical conditions that affect their weight;
  • Children taking medication that affect appetite or weight;
  • Children with severe developmental delay or disability that would affect participation;
  • Children or parents with psychological illness that would limit treatment participation;
  • Families who will move out of the area within the time frame of the study.

结局指标

主要结局

Change in BMI percentile

时间窗: 6 months and 18 months

Change in BMI percentile at the end of treatment and follow-up period

次要结局

  • Child feeding questionnaire(6 months and 18 months)
  • Percent of families who Drop-out of study(6 months)
  • Child Report of Parent Behavior Inventory(6 months and 18 months)
  • Percent of families who adhered to treatment goals(6 months)
  • Percentage of sessions attended between groups(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kay Rhee

Associate Professor of Pediatrics

University of California, San Diego

研究点 (2)

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