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临床试验/NCT02672748
NCT02672748已完成不适用

Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation

University of Wyoming2 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2015年11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
338
试验地点
2
主要终点
Adult BMI change

研究概览

简要总结

The Growing Resilience research leverages reservation-based assets of land, family, culture, and front-line tribal health organizations to develop and evaluate home food gardens as a family-based health promotion intervention to reduce disparities suffered by Native Americans in nearly every measure of health. Home gardening interventions show great promise for enabling families to improve their health, and this study aims to fulfill that promise with university and Wind River Indian Reservation partners. The investigators will develop an empowering, scalable, and sustainable family-based health promotion intervention with, by, and for Native American families and conduct the first RCT to assess the health impacts of home gardens.

详细描述

The intervention is comprised of designing and providing two years of support for home gardens. Families randomized to intervention will receive the following supports and services:

  1. Blue Mountain Associates will host a gardening workshop to include crop planning, receipt of customized guides to the crops the family selects (these are currently in development and will be ready by 2015), and hands-on basic skills training (mid-April). CHRs and interested local healthcare providers will also participate in workshops to help them prepare for supporting gardeners.
  2. BMA's garden manager and assistant(s) will visit each family to help the family install a garden and will provide the family with all needed supplies (late April to early May). Based on garden harvest measures collected in the Food Dignity project and the large gardens preferred by families in the pilot, the minimum garden size will be 80 sq. ft. with at least 30 sq. ft. devoted to crops other than corn and potatoes. The manager will design at least part of each garden in a way that allows the least physically able family members to participate in gardening.
  3. BMA will host a Facebook support and networking group for gardeners, with ARI, BMA, and UW gardening experts providing advice as needed.
  4. BMA's staff will visit each gardening family at least twice more during the growing season and will be available throughout the season for phone consultations and Facebook advice. For all years, the BMA garden manager will track actual intervention support provided to each family (e.g., timing and number of visits, training and supplies provided).

The University of Wyoming research team will collect health measures before and at the end of each gardening season with gardening and control families for two years, after which the control families also receive the gardening intervention. The investigators anticipate enrolling about 100 families into the study with 400 (half adults, half children) people participating in the health measures.

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 primary data analyst will not know which set of results are from people in the gardening vs. the control condition.

入排标准

年龄范围
5 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-identify as having one or more household members who are enrolled in a tribe
  • express interest in having a food garden
  • express willingness to wait to create a food garden for two years if randomized to control
  • live within the boundaries of Wind River Indian Reservation, including the City of Riverton.
  • if the household has two or more adults, that at least two adults in the household express willingness to participate in the semi-annual data gathering for two years.

排除标准

  • had a home food garden plot in the previous year that is over 30 square feet in area.

结局指标

主要结局

Adult BMI change

时间窗: Change from baseline at 2 years

With four data points, every 6 months. Researcher-measured height (stadiometer) and Tanita body composition scale.

次要结局

  • Hb A1C change(Change from baseline at 2 years)
  • Pain change(Change from baseline at 2 years)
  • Self-efficacy in gardening change(Change from baseline at 2 years)
  • Mental Health change(Change from baseline at 2 years)
  • Physical Health change(Change from baseline at 2 years)
  • Food security change(Change from baseline at 2 years)
  • Blood pressure change(Change from baseline at 2 years)
  • hand strength change(Change from baseline at 2 years)
  • waist circumference change(Change from baseline at 2 years)
  • beta-carotene change(Change from baseline at 2 years)
  • cholesterol change(Change from baseline at 2 years)
  • triglycerides change(Change from baseline at 2 years)
  • vitamin D change(Change from baseline at 2 years)
  • child BMI z-score change(Change from baseline at 2 years)

研究者

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

Christine Porter

Associate Professor

University of Wyoming

研究点 (2)

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