Clinical trial NCT05275231: Better Together Study
Official title: Better Together: A Patient-centered Approach to Improve Diabetes Among Immigrant Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Immigrant
South Asian born Immigrant
African born Immigrant
Social Contact
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-03-11
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Group Preference
timeFrame: Baseline
measure: Feasibility: Proportion of Subjects Who Enroll
timeFrame: Baseline
measure: Retention: Number of Sessions Attended
timeFrame: From baseline to week 16
measure: Acceptability: Satisfaction Questionnaire
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
measure: Changes in Body Mass Index (BMI)
timeFrame: Baseline, month 6
measure: Changes in Abdominal Waist Circumference
timeFrame: Baseline, month 6
measure: Changes in Diastolic Blood Pressure
timeFrame: Baseline, month 6
measure: Changes in Hemoglobin A1c
timeFrame: Baseline, month 6
measure: Changes in Body Weight
timeFrame: Baseline, month 6
measure: Changes in Systolic Blood Pressure
timeFrame: Baseline, month 6
measure: Changes in Physical Activity
timeFrame: Baseline, month 6
measure: Changes in Diet
timeFrame: Baseline, month 6
measure: Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts
timeFrame: Baseline and month 6
Locations:
city: Dunwoody
country: United States
facility: Emory Family Medicine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Megha Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: