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临床试验/NCT02441049
NCT02441049Unknown不适用

Latino Mothers as Primary Agents of Change

San Diego State University2 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
361
试验地点
2
主要终点
Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener

研究概览

简要总结

Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society. The study was conducted in Imperial County, California, and involved a partnership between the Institute for Behavioral and Community Health at San Diego State University and Clínicas de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties. The investigators enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25% of families, the father was also enrolled. Participants were randomly assigned to either an intervention or delayed-treatment control condition. The intervention consisted of a community health worker (or promotora)-delivered home-based intervention to promote healthy eating. The promotoras used a telenovela DVD series and accompanying manual, both written and produced by study staff. The intervention was delivered through 11 home visits and 4 support telephone calls over a 4 month period. Participants in the delayed-treatment condition received intervention materials when evaluation assessments had been completed. Evaluation measures were taken at baseline, 4 months (immediate post-intervention) and 10 months (6-months post intervention). Participants completed a self-report interview with study staff at each time point. Height and weight measurements were also collected for the mothers and children. The primary outcomes were changes in mothers' daily fruit and vegetable intake. Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary beverage intake, parenting strategies, and perceived barriers to healthy eating.

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
None

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

  • must self-identify as Latina,
  • must be able to read and speak Spanish,
  • must be at least 18 years old,
  • must be a resident of Imperial County,
  • and must plan to reside in the county for the 10 month study duration.
  • Children (both genders):
  • must be between the ages of 7-13 years,
  • must reside with his/her mother and her spouse/partner for at least 4 days of the week.

排除标准

  • Families who intend to move away from Imperial County before the end of the study, and families with a family member on a medically-prescribed diet

结局指标

主要结局

Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener

时间窗: Baseline, 4 months, 10 months

次要结局

  • Child, father: change in daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener(Baseline, 4 months, 10 months)
  • Mother, child, father: change in monthly fruit and vegetable variety between baseline, immediate-post intervention and 6-months post-intervention, assessed using self-reported intake of 32 fruits and 43 vegetables(Baseline, 4 months, 10 months)
  • Mother, father: change in perceived quality of diet between baseline, immediate-post intervention and 6-months post-intervention, assessed using one item from the 2005-06 NHANES (Diet Behavior and Nutrition module)(Baseline, 4 months, 10 months)
  • Mother, father: change in parenting strategies between baseline, immediate-post intervention and 6-months post-intervention, assessed using a modified version of the PEAS scale(Baseline, 4 months, 10 months)
  • Mother: change in social support for fruit and vegetable intake between baseline, immediate-post intervention and 6-months post-intervention, assessed using a modified version of preexisting F&V shopping practices and social support scales(Baseline, 4 months, 10 months)
  • Mother, child, father: change in weekly fast food intake between baseline, immediate-post intervention and 6-months post-intervention, assessed by asking for self-reported number of days in a typical week the respondent ate at fast food restaurants(Baseline, 4 months, 10 months)
  • Mother, father: change in perceived barriers to obtaining and consuming fruits and vegetables between baseline, immediate-post intervention and 6-months post-intervention, assessed using 11-items including ease of purchasing F&V in the neighborhood(Baseline, 4 months, 10 months)
  • Mother, father: change in fat intake between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Multifactor Fat Screener(Baseline, 4 months, 10 months)

研究者

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

Guadalupe X. Ayala

Professor

San Diego State University

研究点 (2)

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