Developing a Lifestyle Intervention for South Asians

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT03861546

Collaborator

(none)

Enrollment

Location

Arm

3.7

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Behavior, Health Pre Diabetes Diabetes	Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 3, 2019

Actual Primary Completion Date :

Jun 23, 2019

Actual Study Completion Date :

Jun 23, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 blood pressure [Baseline, 4 months, and 12 months]
Blood pressure will be measured pre- and post- intervention
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 physical activity daily minutes [Baseline, 4 months, and 12 months]
Daily minutes of moderate intensity exercise will be self reported by participants
Change in step counts [Baseline, 4 months, and 12 months]
Daily step counts (using wearable perdometer) will be recorded.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.