Better Together Study

Better Together: A Patient-centered Approach to Improve Diabetes Among Immigrant Communities

This study (Aim 1) seeks to test that a culturally-tailored lifestyle intervention is feasible and acceptable for immigrant men from South Asia and West Africa. This will be a pre-post pilot study of a 16-week lifestyle program for South Asians and West Africans with prediabetes or diabetes in Atlanta. Patients will participate in health-professional-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Groups will be followed at baseline, 4 months and 12 months. Groups will be separated by region of origin (i.e. separate groups for South Asians and West Africans). For Aim 2,the study team will assess intervention spillover effects among participant's self-identified social networks. The study team will ask participants in Aim 1 to name 5 people in their social networks to participate in a survey of health behaviors at baseline and 12-months to assess health behavior practices.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Intensive lifestyle interventions (ILIs)

Detailed Description

South Asians and Africans are growing immigrant groups at high risk for diabetes in the US. South Asian (SA) (ancestry originating from India, Pakistan, Bangladesh and other parts of South Asia) and Sub-Saharan African immigrant groups make up two of the fastest growing immigrant groups in the US. SAs have higher rates of T2D and cardiovascular disease than whites. Furthermore, SAs without diabetes have a high prevalence of T2D risk factors.

Sub-Saharan African-born immigrants (the proposed study will focus on West African (WA) countries: those originating from Benin, Burkina Faso, Cape Verde, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Liberia, Mali, Mauritania, Niger, Nigeria, Senegal, Sierra Leone, and Togo), whose population in the US has doubled every decade since 1980, are also at high risk for T2D. Dietary patterns of African immigrants are high in carbohydrates and animal protein, compared to African populations who did not immigrate.

These findings in SA and African immigrant communities challenge the well-accepted "healthy immigrant effect" phenomenon (that immigrants are on average healthier than native-born persons), suggesting that more tailored T2D prevention and management strategies are greatly needed to narrow the disparities in outcomes between these and other US populations. Previous trials showed that intensive lifestyle interventions (ILIs), group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease T2D incidence in people with prediabetes and reduced complications among people with T2D. Additional analyses have shown that the effects of lifestyle interventions are long-lasting, even when participants gain back some of the weight lost during the program.

Family and social networks could be an important factor to improve patient activation, especially for South Asian and African immigrant men. Social networks, defined as someone with social or family ties to an individual, affect health through myriad mechanisms including social support, social influence, social engagement, and access to resources. This study aims to focus on SA and WA immigrant men as model populations to examine preferences, feasibility, and acceptability for a shared medical appointment (SMA) intervention based in primary care and developed with user-driven input and changes in healthy lifestyle practices among participants' social networks. This will be a pre-post pilot study of a 16-week lifestyle program for the mentioned immigrant groups with prediabetes or diabetes in Atlanta. Patients will participate in health-professional-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Groups will be followed at baseline, 4 months and 12 months. For Aim 2, the study team will assess intervention spillover effects among participant's self-identified social networks. The study team will ask participants in Aim 1 to name 5 people in their social networks to participate in a survey of health behaviors at baseline and 12-months to assess health behavior practices.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Dunwoody, Georgia, United States, 30338
      • Emory Family Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Aim 1:

• Men >18 years of age
• Diagnosis of Type 2 Diabetes (T2D) (documented A1c of ≥ 5.7% or fasting blood glucose of >100) or prediabetes
• A family member or peer is willing to participate and attend all sessions as a social partner (if enrolling in dyad arm)
• Proficiency in English(if in dyad, at least one member of each dyad)
• Willingness to provide written consent

Inclusion Criteria for Aim 2:

• Proficient in English
• Age greater than or equal to 18 years

Exclusion Criteria Aim 1 and 2:

• 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
• Diagnosed with cognitive deficits or limited decision-making capacity
• Alcohol or substance abuse
• Homelessness or no fixed address.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyads; This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.	Behavioral: Intensive lifestyle interventions (ILIs); Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
Active Comparator: Men Only; This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.	Behavioral: Intensive lifestyle interventions (ILIs); Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Group Preference	Which group of the study are participants choosing between the single participant group or the dyad. Preferences will be assessed by quantifying number enrolled in each group.	Baseline
Feasibility: Proportion of Subjects Who Enroll	The proportion of adults who are contacted and informed about the study and who enroll during study baseline. Feasibility will be assessed by quantifying rate of enrollment, number of sessions attended by participants (for dyad arm, will assess participant and social contact, individually and together).	Baseline
Retention: Number of Sessions Attended	Number of sessions attended; for dyads, this would include sessions attended together and separately, over the 16-week study period. There were 5 sessions total.	From baseline to week 16
Acceptability: Satisfaction Questionnaire	Questionnaires assessed participant perceptions of ILI after the program to evaluate satisfaction with the program and suggestions for program improvement. Acceptability will be assessed by quantifying Likert-like scales of satisfaction of overall intervention. This is a 0 to 5 scale, where "0" represents the least level of satisfaction and "5" represents the highest level of satisfaction.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body weight	Participant's weight will be measured in kilograms using a calibrated, standardized scale.	Baseline, month 4 and month 12
Changes in Body Mass Index (BMI)	Participant's weight will be measured in kilograms using a calibrated, standardized scale, and height will be measured in meters (m), using a standardized stadiometer. BMI will be calculated using the standard formula of kg/m^2.	Baseline, month 4 and month 12
Changes in abdominal waist circumference	Waist circumference will be measured in centimeters (cm) by the World Health Organization recommended method.	Baseline, month 4 and month 12
Changes in Systolic Blood pressure	Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg.	Baseline, month 4 and month 12
Changes in Diastolic Blood pressure	Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg.	Baseline, month 4 and month 12
Changes in physical activity	Participants will be asked to keep a daily activity log (minutes of exercise performed daily will be logged). All logged exercises will be considered physical activity. The study coordinators will measure the amount in hours of exercise performed and compare each participant's log at the different time points to asses in that subject's physical activity.	Baseline, month 4 and month 12
Changes in diet	Changes in diet will be measured using the Rapid Eating and Activity Assessment for Participants short version (REAP-S). The REAP-S consists of 13 scored questions. Responses of 'usually/often' receive 1 point, 'sometimes' receives 2 points, and 'rarely/never or does not apply to me' receives 3 points. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality.	Baseline, month 4 and month 12
Changes in weight of participant's social contact	This outcome will measure for potential changes in weight of the established social contacts of the participant. Their weight, in kilograms, will be checked at baseline and at month 12 to study potential weight loss as a spillover effect of being the support contacts of the study participants.	Baseline and month 12
Changes in Hemoglobin A1c	Participant's Hemoglobin A1c (HbA1c) will be measured with a point-of-care testing (POCT) well-validated clinical instrument. Normal values for HbA1c are below 5.7% while values of 6.5% and above indicate diabetes.	Baseline, month 4 and month 12
Changes in plasma lipids	Plasma lipids will be measured with a point-of-care testing (POCT) well-validated clinical instrument.	Baseline, month 4 and month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Mass Index (BMI)	Participant's weight will be measured in kilograms using a calibrated, standardized scale, and height will be measured in meters (m), using a standardized stadiometer. BMI will be calculated using the standard formula of kg/m^2.	Baseline, month 6
Changes in Abdominal Waist Circumference	Waist circumference will be measured in centimeters (cm) by the World Health Organization recommended method.	Baseline, month 6
Changes in Diastolic Blood Pressure	Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg.	Baseline, month 6
Changes in Hemoglobin A1c	Participant's Hemoglobin A1c (HbA1c) will be measured with a point-of-care testing (POCT) well-validated clinical instrument. Normal values for HbA1c are below 5.7% while values of 6.5% and above indicate diabetes.	Baseline, month 6
Changes in Body Weight	Participant's weight will be measured in kilograms using a calibrated, standardized scale.	Baseline, month 6
Changes in Systolic Blood Pressure	Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg.	Baseline, month 6
Changes in Physical Activity	Participants will be asked to keep a daily activity log (minutes of exercise performed daily will be logged). All logged exercises will be considered physical activity. The study coordinators will measure the amount in hours of exercise performed and compare each participant's log at the different time points to asses in that subject's physical activity	Baseline, month 6
Changes in Diet	Changes in diet will be measured using the Rapid Eating and Activity Assessment for Participants short version (REAP-S). The REAP-S consists of 13 scored questions. Responses of 'usually/often' receive 1 point, 'sometimes' receives 2 points, and 'rarely/never or does not apply to me' receives 3 points. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality.	Baseline, month 6
Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts	Participants' social contacts will complete the WCSS. The WCSS is a 30-item questionnaire asking about weight control practices. Responses are given on a 5-point scale when 0 = never and 4 = always. A total score is calculated by taking the average of responses and ranges from 0 to 4 where higher scores indicate greater use of strategies to lose or maintain weight.	Baseline and month 6

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Megha Shah, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Immigrant; South Asian born Immigrant; African born Immigrant; Social Contact
• Other Study ID Numbers: STUDY00000967; 1K23MD015088-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any de-identified data, upon request
• IPD Sharing Time Frame: Data will be available 6 months after data collection is complete
• IPD Sharing Access Criteria: De-identified Data will be available to any party who completes a data use agreement that describes for what purpose the data will be used with a clear analysis plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No