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Developing a Lifestyle Intervention for South Asians

Primary Purpose

Behavior, Health, Pre Diabetes, Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Healthy lifestyle Shared Medical Appointment (SMA) program

About this trial

This is an interventional health services research trial for Behavior, Health focused on measuring South Asian adults, Patient-centered approach, Intensive lifestyle interventions, Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age > 18 years;
confirmed diagnosis of prediabetes or T2D (documented A1c of ≥ 5.7%, 2-hour post-load glucose of >140, or FBG of >100);
a family member or peer willing to participate and attend all sessions as a social influencer;
proficiency in English of at least one member of each dyad,
willingness to provide written consent.

Exclusion Criteria:

type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced);
malignancy or life-threatening illness with life expectancy of <5 years;
end-stage disease or serious illness that prohibits participation (e.g. end-stage renal disease or class IV congestive heart failure);
inability to perform unsupervised physical activity;
pregnancy;
diagnosed cognitive deficits or limited decision-making capacity;
alcohol or substance abuse;
homelessness or no fixed address.

Sites / Locations

Emory Family Medicine Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy lifestyle Shared Medical Appointment (SMA) program

Arm 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.

Outcomes

Primary Outcome Measures

Participant perceptions of SMA program

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

SMA program retention rate

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

Secondary Outcome Measures

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.

Change in blood pressure

Blood pressure will be measured pre- and post- intervention

Change in blood cholesterol level

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

Change in physical activity daily minutes

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

Change in step counts

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

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.

Full Information

NCT ID

NCT03861546

First Posted

March 1, 2019

Last Updated

November 15, 2019

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT03861546

Brief Title

Developing a Lifestyle Intervention for South Asians

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

March 3, 2019 (Actual)

Primary Completion Date

June 23, 2019 (Actual)

Study Completion Date

June 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behavior, Health, Pre Diabetes, Diabetes

Keywords

South Asian adults, Patient-centered approach, Intensive lifestyle interventions, Diabetes

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy lifestyle Shared Medical Appointment (SMA) program

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Healthy lifestyle Shared Medical Appointment (SMA) program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Participant perceptions of SMA program

Description

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

Time Frame

4 months

Title

SMA program retention rate

Description

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

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Change in body mass index (BMI)

Description

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