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临床试验/NCT04852042
NCT04852042已完成不适用

Digital Health Supported Weight Management Intervention Delivered by Community Health Workers Among Public Housing Residents

Tufts Medical Center2 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2021年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
316
试验地点
2
主要终点
Change in Weight at 12-month follow up

研究概览

简要总结

This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments.

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
All
接受健康志愿者

入选标准

  • Current resident of Boston public housing development
  • No plans to move within the next 6 months and no plan on leaving the country for more than 2 months over the next year
  • Able to read and speak in English or Spanish
  • Has cell phone with a plan that allows for unlimited text messages
  • Willing to wear a device to track physical activity during assessment periods

排除标准

  • Currently enrolled in a comprehensive weight loss program or a research study about weight that is incompatible with study participation
  • Currently on a medically prescribed diet or fast that is incompatible with study participation
  • Currently has a diagnosis of bipolar disorder, mania, manic-depressive disorder, schizophrenia, or psychosis and is not on any medications to treat the condition
  • Precontemplation stage of change for making healthy eating or physical activity changes
  • Pregnancy
  • Medical contraindications to physical activity. Self-reported presence of any of the following:
  • Can not walk without help from someone else
  • Regularly needs to use the following special equipment to walk or get around: wheelchair, scooter, walker, or extra oxygen
  • Gets short of breath even when using special equipment at a very low level of physical activity such as walking around the home, making a bed, or taking a bath
  • Advised by a healthcare professional not to exercise and or if diagnosed with a bone or joint problem, it could get worse.
  • Frequently gets pains in the heart or chest
  • Had a heart attack in the past 6 months
  • Often feels faint or has spells of severe dizziness
  • Has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110
  • Has a good physical reason not to follow an activity program even if they wanted to

结局指标

主要结局

Change in Weight at 12-month follow up

时间窗: Baseline, 12-month follow up

Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading.

次要结局

  • Physical activity behavior(Baseline, 6-month follow up, 12-month follow up)
  • Psycho-social variables(Baseline, 6-month follow up, 12-month follow up)
  • Diet behavior(Baseline, 6-month follow up, 12-month follow up)
  • Change in Weight at 6-month follow up(Baseline, 6-month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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