Better Together Study

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.

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

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Intensive lifestyle interventions (ILIs)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dyads<br>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)<br>* 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.<br>|
| Active Comparator: Men Only<br>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)<br>* 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.<br>|

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. | From baseline to week 16 | 
| 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 12 months | 
| Acceptability: Changes in Satisfaction questionnaire | Participant perceptions of ILI assessed by questionnaires at conclusion of program to evaluate satisfaction with the program and suggestions for program improvement. Acceptability will be assessed by quantifying Likert-like scales of satisfaction with each session and 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. | Baseline, month 4 and month 12 | 

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 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 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 plasma lipids | Plasma lipids will be measured with a point-of-care testing (POCT) well-validated clinical instrument. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immigrant, South Asian born Immigrant, African born Immigrant, Social Contact