N/A
Completed N=54
Better Together Study
Source: ClinicalTrials.gov NCT05275231 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Recruitment Group Preference — 54 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Group Preference |
54 | — |
| PRIMARY Feasibility: Proportion of Subjects Who Enroll |
54 | — |
| PRIMARY Retention: Number of Sessions Attended |
4.7 | — |
| PRIMARY Acceptability: Satisfaction Questionnaire |
5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05275231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.