Developing a Lifestyle Intervention for South Asians

Emory University

Status: Completed

Conditions: Diabetes; Pre Diabetes; Behavior, Health

Treatments: Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program

Study type: Interventional

Funder types: Other

Identifiers

NCT03861546

IRB00097724

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Healthy lifestyle Shared Medical Appointment (SMA) program

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program