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临床试验/NCT03111680
NCT03111680已完成不适用

Healthy Families: a Cluster Randomized Study to Change Obesity in Public Housing

University of Washington1 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
1
主要终点
healthy eating

研究概览

简要总结

This is a cluster randomized study of an environmental level intervention to improve nutrition and physical activity, among public housing residents. Followup was one year post baseline

详细描述

Purpose and design The purpose of this study was to test the effects of a environmental-level package of interventions on public housing residents' obesity and obesity-related behaviors. The design of the study and its intervention have been previously published . Simply, this was a cluster randomized trial, with public housing developments (PHDs) serving as the unit of randomization and analysis. This document describes the patterns of change in the main behavioral and weight outcomes for adult women before and after the intervention.

Participants Public housing in Boston is administered by the Boston Housing Authority (BHA), a public agency that provides subsidized housing to low- and moderate-income individuals and families, disabled individuals, and elderly individuals. There are 64 public housing developments, 37 are designated as elderly/disabled developments and 27 are designated as family developments. Approximately 27,000 people are housed under the public housing program.

Family (vs. elderly) designated PHDs with more than 200 residents which were not undergoing renovations requiring residents to move out of the development for a period of time in the City of Boston were eligible to participate in this study (n=24). The investigators recruited 10 developments to participate in the Healthy Families study; 5 serving as intervention PHDs and 5 serving as control PHDs. PHDs were randomly assigned to either condition, in matched pairs for size of development and existence of health activities in the development. PHDs randomized to the intervention group received all intervention components (see Intervention section below) and developments randomized to the control group did not receive any intervention components.

Data collection In both intervention and control group PHDs, a randomly sampled group of female residents and their daughters ages 8-16 were recruited into an evaluation cohort to examine study outcomes. The investigators selected mothers because in the family developments over 80% of heads of household (per aggregate data compiled from tenant agreements) were women. The investigators selected daughters aged 8-15 as development of obesity often occurs during this time period for females. To be eligible for this study, participants were required to be female, age 18-72, live in one of the recruited PHD, and planning to remain so for two years, had responsibility for a girl age 8-15 (also living in the public housing residence), were English or Spanish speaking, and were able to make changes to their diet and physical activity habits if desired. Exclusion criteria included: the adult was not able to complete the survey tools or was not interested in participating. All study materials were available and used in both English and Spanish.

Survey assistants approached randomly selected apartment units within each of the 10 housing developments. Using a standardized protocol, survey assistants assessed individual's interest in participating and eligibility. If interested and eligible, the participant provided their written informed consent to participate, girls aged 12-15 provided written assent, and girls aged 8-11 gave verbal assent. The survey assistant then administered the baseline survey and recorded the (adult) participant's responses. After completing the survey, the women and girl's height and weight were measured and recorded. Project staff returned to re-assess the original evaluation cohort at one- year follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Care Provider, Investigator)

盲法说明

people collecting data were unaware of study condition

入排标准

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

入选标准

  • •residing in public housing able to read spanish or english mother of a child aged 6-17

排除标准

  • 未提供

研究组 & 干预措施

intervention

Experimental

this arm received an environmental intervention to make healthy eating and activity easier for residents

干预措施: environmental intervention (Other)

control

No Intervention

the control participants received no interventions

结局指标

主要结局

healthy eating

时间窗: in the last three months

fruit and vegetable servings per day

healthy physical activity

时间窗: in the last three months

time spent doing moderate physcial activity

次要结局

未报告次要终点

研究者

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

Deborah Bowen

Professor

University of Washington

研究点 (1)

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