Clinical trial NCT03861546: Developing a Lifestyle Intervention for South Asians
Official title: Better Together: Leveraging Primary Care and Social Network Resources to Create a Patient-centered Approach to Improve Diabetes Among South Asians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Pre Diabetes
Diabetes
Keywords: South Asian adults
Patient-centered approach
Intensive lifestyle interventions
Diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant perceptions of SMA program
timeFrame: 4 months
measure: SMA program retention rate
timeFrame: 4 months
Secondary outcomes:
measure: Change in body mass index (BMI)
timeFrame: Baseline, 4 months, and 12 months
measure: Change in blood pressure
timeFrame: Baseline, 4 months, and 12 months
measure: Change in blood cholesterol level
timeFrame: Baseline, 4 months, and 12 months
measure: Change in physical activity daily minutes
timeFrame: Baseline, 4 months, and 12 months
measure: Change in step counts
timeFrame: Baseline, 4 months, and 12 months
measure: Change in diet
timeFrame: Baseline, 4 months, and 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Family Medicine Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Megha K Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.