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临床试验/NCT03861546
NCT03861546已完成不适用

Better Together: Leveraging Primary Care and Social Network Resources to Create a Patient-centered Approach to Improve Diabetes Among South Asians

Emory University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年3月3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
14
试验地点
2
主要终点
SMA program retention rate

研究概览

简要总结

This study aims to test the hypothesis that a culturally tailored lifestyle intervention can improve health behaviors among South Asians with prediabetes and diabetes

详细描述

This pre-post pilot study is a 16 week lifestyle program for South Asians with prediabetes or diabetes in Atlanta. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • age > 18 years;
  • confirmed diagnosis of prediabetes or T2D (documented A1c of ≥ 5.7%, 2-hour post-load glucose of >140, or FBG of >100);
  • a family member or peer willing to participate and attend all sessions as a social influencer;
  • proficiency in English of at least one member of each dyad,
  • willingness to provide written consent.

排除标准

  • type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced);
  • malignancy or life-threatening illness with life expectancy of <5 years;
  • end-stage disease or serious illness that prohibits participation (e.g. end-stage renal disease or class IV congestive heart failure);
  • inability to perform unsupervised physical activity;
  • diagnosed cognitive deficits or limited decision-making capacity;
  • alcohol or substance abuse;
  • homelessness or no fixed address.

结局指标

主要结局

SMA program retention rate

时间窗: 4 months

Number of participants retained will be recorded and SMA retention rate will be calculated

Participant perceptions of SMA program

时间窗: 4 months

Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.

次要结局

  • Change in blood pressure(Baseline, 4 months, and 12 months)
  • Change in diet(Baseline, 4 months, and 12 months)
  • Change in blood cholesterol level(Baseline, 4 months, and 12 months)
  • Change in body mass index (BMI)(Baseline, 4 months, and 12 months)
  • Change in step counts(Baseline, 4 months, and 12 months)
  • Change in physical activity daily minutes(Baseline, 4 months, and 12 months)

研究者

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

Megha Kumudchandra Shah

Principal Investigator

Emory University

研究点 (2)

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