Developing a Lifestyle Intervention for South Asians

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Behavior, Health, Pre Diabetes, Diabetes

Intervention / Treatment
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* Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program


Participation Criteria
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Eligibility Criteria
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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; pregnancy; diagnosed cognitive deficits or limited decision-making capacity; alcohol or substance abuse; homelessness or no fixed address.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy lifestyle Shared Medical Appointment (SMA) program<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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South Asian adults, Patient-centered approach, Intensive lifestyle interventions, Diabetes