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Clinical Trials/NCT05275231
NCT05275231CompletedNot Applicable

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

Emory University1 site in 1 country108 target enrollmentStarted: April 4, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
108
Locations
1
Primary Endpoint
Recruitment Group Preference

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Arms & Interventions

Dyads

Experimental

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.

Intervention: Intensive lifestyle interventions (ILIs) (Behavioral)

Men Only

Active Comparator

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.

Intervention: Intensive lifestyle interventions (ILIs) (Behavioral)

Outcomes

Primary Outcomes

Recruitment Group Preference

Time Frame: Baseline

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.

Feasibility: Proportion of Subjects Who Enroll

Time Frame: Baseline

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).

Retention: Number of Sessions Attended

Time Frame: From baseline to week 16

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.

Acceptability: Satisfaction Questionnaire

Time Frame: Month 6

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Megha Kumudchandra Shah

Assistant Professor

Emory University

Study Sites (1)

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