Developing a Lifestyle Intervention for South Asians

Diabetes Clinical Trial

Official title:

Better Together: Leveraging Primary Care and Social Network Resources to Create a Patient-centered Approach to Improve Diabetes Among South Asians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861546
• Other study ID #: IRB00097724
• Status: Completed
• Phase: N/A
• Start date: March 3, 2019
• Est. completion date: June 23, 2019

Study information

• Verified date: November 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 23, 2019
• Est. primary completion date: June 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Health
• Diabetes
• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Emory Family Medicine Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant perceptions of SMA program	Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.	4 months
Primary	SMA program retention rate	Number of participants retained will be recorded and SMA retention rate will be calculated	4 months
Secondary	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.	Baseline, 4 months, and 12 months
Secondary	Change in blood pressure	Blood pressure will be measured pre- and post- intervention	Baseline, 4 months, and 12 months
Secondary	Change in blood cholesterol level	Cholesterol level will be measured by blood test pre- and post- intervention	Baseline, 4 months, and 12 months
Secondary	Change in physical activity daily minutes	Daily minutes of moderate intensity exercise will be self reported by participants	Baseline, 4 months, and 12 months
Secondary	Change in step counts	Daily step counts (using wearable perdometer) will be recorded.	Baseline, 4 months, and 12 months
Secondary	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.	Baseline, 4 months, and 12 months