Skip to main content
Clinical Trials/NCT03861546
NCT03861546
Completed
Not Applicable

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

Emory University1 site in 1 country14 target enrollmentMarch 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Behavior, Health
Sponsor
Emory University
Enrollment
14
Locations
1
Primary Endpoint
SMA program retention rate
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2019
End Date
June 23, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Megha Kumudchandra Shah

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

SMA program retention rate

Time Frame: 4 months

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

Participant perceptions of SMA program

Time Frame: 4 months

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

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials