Developing a Lifestyle Intervention for South Asians

NCT ID: NCT03861546

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-03
• Study Completion Date: 2019-06-23

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.

Conditions

Behavior, Health; Pre Diabetes; Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy lifestyle Shared Medical Appointment (SMA) program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Megha Kumudchandra Shah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megha K Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Family Medicine Clinic

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35074000 (View on PubMed)

Other Identifiers

IRB00097724

Identifier Type: -

Identifier Source: org_study_id