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临床试验/NCT07441655
NCT07441655招募中不适用

Families Implementing Good Health Traditions for Life

Morehouse School of Medicine1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年2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
招募中
入组人数
70
试验地点
1

研究概览

简要总结

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

详细描述

The goal of this project is to utilize a community-engaged research approach to reduce type 2 diabetes risk among Black families through the tailoring of the diabetes prevention program for families. The proposed study will be carried out by researchers and community members with expertise in community engagement, type 2 diabetes prevention, and family interventions/programming. It is hypothesized that the Families Implementing Good Health Traditions for Life study (FIGHT for Life), a region specific adaptation of the Diabetes Prevention Program (DPP) for high-risk adults paired with a DPP-adapted curriculum for children will result in improved program acceptance and compliance, thus improving health indicators associated with type 2 diabetes risk across Black families. The efficacy of the community-engaged research-adapted FIGHT for Life intervention to improve weight, an important type 2 diabetes risk factor, in Black parents with pre-diabetes (primary outcome) will be evaluated. The goal is that parents enrolled in the family intervention will demonstrate a 4% reduction in weight at the end of the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Family 1.a.) Black Parent/Guardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old
  • Parent/Guardian have HbA1c level 5.7-6.4% (prediabetes)
  • Parent/Guardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months
  • Parent/child are ambulatory and able to participate in physical activity

排除标准

  • Individuals with severe psychological disorders that may prevent/interfere with study participation
  • Physical impairments that may prevent participation in moderate intensity physical activity;
  • Previous diagnosis of diabetes
  • History of congestive heart failure, renal failure, or recent (<12 months) cardiovascular events such as myocardial infarction or stroke;
  • Person taking medications that may affect endpoint analyses
  • Persons with co-morbid contraindications to physical activity or dietary changes.
  • Currently pregnant or planning to become pregnant in the next year.

研究组 & 干预措施

Families Implementing Good Health Traditions for Life

Other

Seven cohorts with a total of seventy families (10 families per cohort) will be enrolled in the study. Families will meet for weekly for 16 weeks and be administered child and adult specific curriculums to encourage healthy lifestyle changes. The adults will received the initial 16-week curriculum of the CDC's Diabetes Prevention Program, and the children will receive an aligned DPP-adapted curriculum.

干预措施: Families Implementing Good Health Traditions for Life (Behavioral)

研究者

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

Rakale Collins Quarells

Principal Investigator

Morehouse School of Medicine

研究点 (1)

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