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CompletedNCT03861546Updated Nov 18, 2019

Developing a Lifestyle Intervention for South Asians

An interventional study of Healthy lifestyle Shared Medical Appointment (SMA) program in Behavior, Health, Pre Diabetes and Diabetes, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Emory University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Behavior, Health
  • Pre Diabetes
  • Diabetes

Keywords

  • South Asian adults
  • Patient-centered approach
  • Intensive lifestyle interventions
  • Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralHealthy 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.

06

What researchers measure

Primary outcomes

  1. Participant perceptions of SMA program

    Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.

    Time frame: 4 months

  2. SMA program retention rate

    Number of participants retained will be recorded and SMA retention rate will be calculated

    Time frame: 4 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 4 months, and 12 months

  2. Change in blood pressure

    Blood pressure will be measured pre- and post- intervention

    Time frame: Baseline, 4 months, and 12 months

  3. Change in blood cholesterol level

    Cholesterol level will be measured by blood test pre- and post- intervention

    Time frame: Baseline, 4 months, and 12 months

  4. Change in physical activity daily minutes

    Daily minutes of moderate intensity exercise will be self reported by participants

    Time frame: Baseline, 4 months, and 12 months

  5. Change in step counts

    Daily step counts (using wearable perdometer) will be recorded.

    Time frame: Baseline, 4 months, and 12 months

  6. 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.

    Time frame: Baseline, 4 months, and 12 months

07

Study locations

1 site
  • Emory Family Medicine Clinic
    Atlanta, Georgia 30322, United States
08

References and documents

Publications

  • 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. PubMed 35074000 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03861546
Lead sponsor
Emory University
Responsible party
Megha Kumudchandra Shah (Principal Investigator, Emory University) — Principal investigator
First posted
Mar 4, 2019
Start date
Mar 3, 2019
Primary completion
Jun 23, 2019
Completion
Jun 23, 2019
Last update
Nov 18, 2019

Study contacts

Megha K Shah, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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