Developing a Lifestyle Intervention for South Asians

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Pre Diabetes; Behavior, Health
• Intervention / Treatment: Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Family Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy lifestyle Shared Medical Appointment (SMA) program; South Asian (SA) adults with prediabetes and Type 2 Diabetes (T2D) that are 'information rich' and have variation in background characteristics will be identified. Dyads (spouses, parent/adolescent or young adult child, peers) will participate in a 16-week culturally-tailored, community-informed pre-post SMA intervention to improve health behaviors.

Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program; Social network-based, culturally-tailored healthy lifestyle SMA program for high risk SAs will be piloted to collect pre-post data on diet and exercise habits, and to determine feasibility and acceptability. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Biometric measurements (weight, height, blood pressure) will be collected, point of care glucose and lipid testing will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant perceptions of SMA program	Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.	4 months
SMA program retention rate	Number of participants retained will be recorded and SMA retention rate will be calculated	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index (BMI)	Body Mass Index (BMI) is a number representing person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.	Baseline, 4 months, and 12 months
Change in blood pressure	Blood pressure will be measured pre- and post- intervention	Baseline, 4 months, and 12 months
Change in blood cholesterol level	Cholesterol level will be measured by blood test pre- and post- intervention	Baseline, 4 months, and 12 months
Change in physical activity daily minutes	Daily minutes of moderate intensity exercise will be self reported by participants	Baseline, 4 months, and 12 months
Change in step counts	Daily step counts (using wearable perdometer) will be recorded.	Baseline, 4 months, and 12 months
Change in diet	Pre-post assessment of change in consumption will be done using food frequency questionnaire. It has 16 questions that assess dietary habits over the past week.	Baseline, 4 months, and 12 months

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Megha K Shah, MD, Emory University

Publications and helpful links

General Publications

• Shah MK, Naing S, Kurra N, Weber MB, Islam N, Ali MK, Narayan KMV. A culturally adapted, social support-based, diabetes group visit model for Bangladeshi adults in the USA: a feasibility study. Pilot Feasibility Stud. 2022 Jan 24;8(1):18. doi: 10.1186/s40814-022-00974-9.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2019
• Primary Completion (Actual): June 23, 2019
• Study Completion (Actual): June 23, 2019

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; South Asian adults; Patient-centered approach; Intensive lifestyle interventions
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB00097724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No