Better Together Study

NCT05275231 | Completed Results DMC

• 2 other identifiers: STUDY000009671K23MD015088-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Immigrant; South Asian born Immigrant; African born Immigrant; Social Contact

Outcome Measures

Primary Outcomes (4)

• 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

Other Outcomes (9)

• Changes in Body Mass Index (BMI)

  Baseline, month 6

• Changes in Abdominal Waist Circumference

  Baseline, month 6

• Changes in Diastolic Blood Pressure

  Baseline, month 6

Study Arms (2)

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.

Behavioral: Intensive lifestyle interventions (ILIs)

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.

Behavioral: Intensive lifestyle interventions (ILIs)

Interventions

Intensive lifestyle interventions (ILIs) BEHAVIORAL

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.

Dyads; Men Only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Emory Family Medicine Center

Dunwoody, Georgia, 30338, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Megha K. Shah
• Organization: Emory University

mkshah@emory.edu

404-778-6944

Study Officials

• Megha Shah, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 11, 2022
• Study Start: April 4, 2022
• Primary Completion: November 20, 2023
• Study Completion: January 1, 2024
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available 6 months after data collection is complete
• 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.

Locations

US (1)