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临床试验/NCT04273503
NCT04273503已完成不适用

Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
39
试验地点
2
主要终点
Acceptability

研究概览

简要总结

Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.

Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.

详细描述

The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.

Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.

We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-identification as Hispanic or Somali
  • member of an HPs social network
  • age≥18 and <65
  • willingness to participate in all aspects of the study
  • provision of informed consent.

排除标准

  • pregnancy at the time of enrollment
  • serious medical conditions or disabilities that would make physical activity difficult.
  • To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.

结局指标

主要结局

Acceptability

时间窗: 12 weeks

To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants? Interviews with HPs; focus groups and survey with participants.

次要结局

  • Weight(12 weeks)
  • Glucose(12 weeks)
  • Waist circumference(12 weeks)
  • Cholesterol(12 weeks)
  • Height(12 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark L Wieland

Principal Investigator

Mayo Clinic

研究点 (2)

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