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临床试验/NCT01552642
NCT01552642已完成3 期

An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

University of Wisconsin, Madison3 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
77
试验地点
3
主要终点
Feasibility

研究概览

简要总结

The overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

详细描述

Study procedures and interventions:

Pre-intervention: a full-day training will occur with a physician and nurse from each clinic site to be trained as "champions" in counseling.

Intervention:

A letter of introduction will be mailed to potential subjects whose child was seen in the last 6 months for a well-child exam whose BMI is greater than or equal to the 85th percentile. After informed consent is obtained, the subjects will be randomized to the intervention or control group. One parent may join the study.

Groups of 10 to 12 parents of overweight and obese 3 to 6 year olds will meet once weekly for 6 weeks at 5:30 to 6:30 pm with the "nurse champion" in the primary care office. Topics to be presented and discussed include authoritative parenting, using the food plan "Go, Slow, and Whoa", increasing physical activity, and behavior change strategies. Sessions will be audiotaped and independently audited to confirm program fidelity. Parenting skills will be discussed at every session.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • one parent of a 3-6 year old child with a BMI greater than or equal to the 85th percentile
  • Internet access
  • English speaking

排除标准

  • Children with a developmental disorder
  • Children with a chronic underlying disease that may contribute to obesity
  • Children taking medication that may interfere with a healthy weight

研究组 & 干预措施

Intervention Group

Active Comparator

Intervention Group

干预措施: face-to-face meetings and access to a website (Behavioral)

Control Group

No Intervention

Control Group

结局指标

主要结局

Feasibility

时间窗: 1 year

To assess the feasibility of an intervention combining 6 'in-person' group counseling sessions with a 1-year longitudinal web-based component to help parents of overweight children promote healthy behavior change.

Efficacy

时间窗: 1 year

To assess the effectiveness of this intervention program to assist parents of overweight and obese 3-6 year olds in promoting: (a) a modest reduction of child BMI-z scores, (b) healthy behavior changes (related to nutrition and physical activity) for their children, and (c) improved parenting skills.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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