Behavior, Health, Diabetes, Pre Diabetes
Conditions
Keywords
South Asian adults, Patient-centered approach, Intensive lifestyle interventions, Diabetes
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.
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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| Change in step counts | Baseline, 4 months, and 12 months | Daily step counts (using wearable perdometer) will be recorded. |
| Change in blood pressure | Baseline, 4 months, and 12 months | Blood pressure will be measured pre- and post- intervention |
Countries
United States
Outcome results
None listed