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临床试验/NCT01674920
NCT01674920已完成不适用

CHOICES: Family Physicians Treat Overweight Children

University of Arizona2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
body mass index age-and-gender specific Z-score

研究概览

简要总结

CHOICES is a program to provide children and families with lifetime tools and lifestyle strategies to achieve and maintain a healthy body size. Both parents and children get active, learn about the food choices they can make, and about the roles of TV in their lives. Led by physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences that connect into the participants' daily lives. In the study, the families were divided into two groups, beginning their classes 6 months apart. Body measurements were taken at baseline and every 4 months to 16 months.

详细描述

The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity.

Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization.

We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.

排除标准

  • Conditions that would preclude dietary change or physical activity.

结局指标

主要结局

body mass index age-and-gender specific Z-score

时间窗: 9 months post intervention baseline

body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units. It is used to control for growth effects in children.

次要结局

  • weight for age-and-gender specific Z-score(9 months post-intervention baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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