Developing a Lifestyle Intervention for South Asians

Not Applicable

Completed

• Conditions: Behavior, Health; Pre Diabetes; Diabetes
• Interventions: Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program

• Registration Number: NCT03861546
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study Start: 2019-03-03
• Study First Posted: 2019-03-04
• Primary Completion: 2019-06-23
• Study Completion: 2019-06-23
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy lifestyle Shared Medical Appointment (SMA) program	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline, 4 months, and 12 months	Blood pressure will be measured pre- and post- intervention
Change in diet	Baseline, 4 months, and 12 months	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.
Change in blood cholesterol level	Baseline, 4 months, and 12 months	Cholesterol level will be measured by blood test pre- and post- intervention
Change in body mass index (BMI)	Baseline, 4 months, and 12 months	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.
Change in step counts	Baseline, 4 months, and 12 months	Daily step counts (using wearable perdometer) will be recorded.
Change in physical activity daily minutes	Baseline, 4 months, and 12 months	Daily minutes of moderate intensity exercise will be self reported by participants

Trial Locations

Locations (1)

Emory Family Medicine Clinic; 🇺🇸 Atlanta, Georgia, United States