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Completed

NCT Number: NCT03861546

Developing a Lifestyle Intervention for South Asians

This study aims to test the hypothesis that a culturally tailored lifestyle intervention can improve health behaviors among South Asians with prediabetes and diabetes

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Family Medicine Clinic

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy lifestyle Shared Medical Appointment (SMA) program

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.

Primary outcomes

  1. Participant perceptions of SMA program

    Time frame: 4 months

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

  2. SMA program retention rate

    Time frame: 4 months

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

Secondary outcomes

  1. Change in body mass index (BMI)

    Time frame: 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.

  2. Change in blood pressure

    Time frame: Baseline, 4 months, and 12 months

    Blood pressure will be measured pre- and post- intervention

  3. Change in blood cholesterol level

    Time frame: Baseline, 4 months, and 12 months

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

  4. Change in physical activity daily minutes

    Time frame: Baseline, 4 months, and 12 months

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

  5. Change in step counts

    Time frame: Baseline, 4 months, and 12 months

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

  6. Change in diet

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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