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临床试验/NCT01819987
NCT01819987已完成1 期

Home-based & Technology-centered Childhood Obesity Prevention for Mothers With Young Children

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
32
试验地点
2
主要终点
Change from Baseline body mass index at 5 months

研究概览

简要总结

About 17% of Chinese American preschool children are obese, compared to 12.4%of all children from age three to five years residing in the US; the prevalence of obesity is expected to increase in the future. Therefore, the proposed study will adapt a home-based and technology-centered childhood obesity prevention program for low-income Chinese American mothers of children three to five years old. The aims of the study are to assess the feasibility of the intervention and estimate the effect sizes on children's and mothers' outcomes.

详细描述

This study aims to adapt and implement a family-centered and technology-based intervention to prevent obesity in young Chinese American children from low-income families with overweight mothers. The proposed study framework is based on the Information Motivation Behavioral Skills Model, which includes the mothers' gained knowledge/information, increased personal and social motivators, and acquired behavioral skills towards behavioral changes. The intervention will be developed with a Community Advisory Committee and validated for cultural appropriateness through a beta-testing process. The validated intervention will be implemented thereafter. Eligible overweight mothers with young Chinese American children (ages three to five years) will be recruited from local day care settings, low-income housing and Head Start programs to participate in the study. Participants will be randomized into either the intervention (N=15) or control group (N=15). Participants in the intervention group will receive the 8-week online interactive sessions and activities delivered through tablet computers. Participants in the control group will receive general health promotion topics relevant to preschool-age children via mailing materials weekly for eight weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants, investigator and outcome assessor were blinded to the group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Children:
  • must be between ages three and five
  • have a mother who identifies her child as Chinese;
  • be healthy-defined as free of chronic or acute illness.
  • must identify themselves as Chinese
  • the primary provider of the child,
  • be able to speak and read Chinese or English;
  • with a BMI >= 23.0;
  • meet low-income requirements in the Bay Area.

排除标准

  • Have acute or chronic conditions that prevent performing daily activities

结局指标

主要结局

Change from Baseline body mass index at 5 months

时间窗: Baseline and at 5 months

Participants will have their weight and height measured and body mass index will be calculated. Change of BMI from baseline will be assessed at 5 months post baseline

次要结局

  • Change from Baseline Sedentary activity at 2 months(baseline and 2 months)
  • Change from Baseline Parental Feeding Practice at 2 months(baseline and 2 months)
  • Change from baseline physical activity at 2 months(Baseline and 2 months)
  • Change from Baseline Self-efficacy regarding diet and physical activity at 5 months(baseline and 5 months)
  • Change from Baseline Self-efficacy regarding diet and physical activity at 2 months(baseline and 2 months)
  • Change from baseline physical activity level at 5 months(Baseline and 5 months)
  • Change from Baseline Parental Feeding Practice at 5 months(baseline and 5 months)
  • Change from Baseline Sedentary activity at 5 months(baseline and 5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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