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Behavioral Intervention
Lifestyle Changes for Type 2 Diabetes
N/A
Waitlist Available
Led By Megha Shah, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 4 and month 12
Awards & highlights
Study Summary
This trial is testing a lifestyle intervention to see if it's feasible and acceptable for men from South Asia and West Africa with prediabetes or diabetes. The intervention will last 16 weeks and will be focused on improving dietary and exercise habits to reduce weight.
Who is the study for?
The Better Together Study is for South Asian and West African men in Atlanta with prediabetes or Type 2 Diabetes, who are over 18 years old, speak English, and have a peer willing to join them. It's not suitable for those who can't consent or attend the program.Check my eligibility
What is being tested?
This study tests a culturally-tailored lifestyle program aimed at improving diet and exercise among immigrant men from South Asia and West Africa with diabetes. Participants will be monitored over a year to see if their health habits influence their social circles.See study design
What are the potential side effects?
Since this trial focuses on lifestyle changes like diet and exercise, side effects may include muscle soreness from new physical activities or changes in digestion due to dietary adjustments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 4 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 4 and month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability: Changes in Satisfaction questionnaire
Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts
Feasibility: Proportion of subjects who enroll
+2 moreSecondary outcome measures
Changes in Body Mass Index (BMI)
Changes in Body weight
Changes in Diastolic Blood pressure
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DyadsExperimental Treatment1 Intervention
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.
Group II: Men OnlyActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensive lifestyle interventions (ILIs)
2022
N/A
~60
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,518 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,599 Total Patients Enrolled
Megha Shah, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can speak and understand English well.You are 18 years old or older.You are willing to sign a form saying you agree to participate in the study.You need to be able to speak English. If you are in a pair, at least one person must speak English.Men who are 18 years old or older.You have been diagnosed with type 2 diabetes or prediabetes based on blood sugar levels.You need to have a family member or friend who is willing to participate with you and attend all sessions if you are enrolling in the group study.
Research Study Groups:
This trial has the following groups:- Group 1: Men Only
- Group 2: Dyads
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation still welcome new applicants?
"Affirmative. The information readily available on clinicaltrials.gov confirms that recruitment for this trial is currently in progress, with the original posting made on April 4th 2022 and a recent update following shortly after on April 18th 2022. 48 patients are being sought from 1 medical centre."
Answered by AI
Is there a cap on the amount of participants involved in this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is in search of participants, having been posted on April 4th 2022 and revised just recently on April 18th 2022. The requirements include 48 patients to be recruited from one particular clinic."
Answered by AI
What are the primary goals of this medical experiment?
"The principal end point of this trial, which will be monitored at Baseline, month 4 and 12 is to assess participant preference. Auxiliary outcomes include alterations in dietary habits (measured using the REAP-S survey) as well as changes in the weight of social contacts and body mass index of participants."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Emory Family Medicine Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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