跳至主要内容
临床试验/NCT04195477
NCT04195477已完成不适用

Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination

Yale University4 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年10月7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
96
试验地点
4
主要终点
Change in BMI

研究概览

简要总结

The goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). The goal of the intervention is to improve body weight, blood pressure, diet quality, and physical activity levels among low-income individuals at risk for type 2 diabetes.

详细描述

Specific aims and hypotheses:

  1. Conduct formative research with community partners (via focus groups and interviews with key stakeholders and a small pilot) to assess community, systemic, technology, and structural level barriers to implementation of a virtually-delivered Diabetes Prevention Program.

Hypothesis: These efforts will identify individual and community needs, barriers, and resources affecting the feasibility of v-DPP implementation. In addition, strategies for facilitating the delivery of the v-DPP to low-income communities will be developed. 2. In collaboration with community partners, utilize strategies identified in Aim A1 to maximize impact of the v-DDP in target communities, as evidenced by measures of reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) and assess factors influencing RE-AIM outcomes (e.g. social determinants of health, demographic variables, self-efficacy).

Hypothesis: The v-DPP facilitated by community-based care coordination will produce favorable RE-AIM outcomes. Factors influencing these outcomes will be explored as well. 3. Demonstrate improvements in body weight, blood pressure, diet quality, and physical activity in low-income individuals at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination.

Hypothesis: The v-DPP, facilitated by community-based care coordination provided by CHWs and HCNs, will improve body weight, blood pressure, diet quality, and physical activity levels in the study communities. 4. Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP facilitated by community-based care coordination in the study communities and translate it to other community settings.

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

  • BMI ≥ 25 kg/m2, based on self-reported weight and height;
  • Eligible for Medicaid, as determined by self-reported income, household size, and Connecticut state guidelines for Medicaid eligibility;
  • At risk for prediabetes, as evidenced by a score of 5 points or higher on the CDC prediabetes risk screening test. [https://www.cdc.gov/prediabetes/takethetest/]
  • Participants in New Haven must also be residents of an ECC community (Housing Authority).
  • Participants in Derby and Ansonia must demonstrate proof of residency of either town (i.e., bill or other mail addressed to them).

排除标准

  • Failure to meet inclusion criteria;
  • Anticipated inability to complete study protocol for any reason;
  • Self-reported current eating disorder;
  • Inability to exercise;
  • Non-English speaking;
  • Pregnant or planned pregnancy in next 12 months;
  • Self-reported diagnosis of type 1 or type 2 diabetes;
  • Failure to pass vDPP provider's required qualification step assessing readiness to change, when available.

结局指标

主要结局

Change in BMI

时间窗: 16 weeks and 12 months

Body mass index (BMI) will be measured as a participant's weight in kilograms divided by his/her height in meters squared. Height will be collected by a RA/CHW/HCN using a stadiometer at baseline and at 4 weeks.

次要结局

  • Change in Total Cholesterol(16 weeks and 12 months)
  • Change in Triglycerides(16 weeks and 12 months)
  • Change in High-density Lipoprotein(16 weeks and 12 months)
  • Change in Waist Circumference(16 weeks and 12 months)
  • Change in Diet Quality(16 weeks and 12 months)
  • Change in Physical Activity(16 weeks and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验