Intensive lifestyle interventions (ILIs) for Type 2 Diabetes

Emory Family Medicine Center, Dunwoody, GA
Type 2 DiabetesIntensive lifestyle interventions (ILIs) - Behavioral

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.

Treatment Effectiveness

Study Objectives

5 Primary · 9 Secondary · Reporting Duration: Baseline, month 4 and month 12

Feasibility: Proportion of subjects who enroll
Recruitment group preference
Baseline and 12 months
Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts
Baseline and month 12
Changes in weight of participant's social contact
Month 12
Acceptability: Changes in Satisfaction questionnaire
Changes in Body Mass Index (BMI)
Changes in Body weight
Changes in Diastolic Blood pressure
Changes in Hemoglobin A1c
Changes in Systolic Blood pressure
Changes in abdominal waist circumference
Changes in diet
Changes in physical activity
Week 16
Retention: Number of Sessions attended

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Men Only
1 of 2
1 of 2

Active Control

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Intensive lifestyle interventions (ILIs) · No Placebo Group · N/A

Experimental Group · 1 Intervention: Intensive lifestyle interventions (ILIs) · Intervention Types: Behavioral
Men Only
ActiveComparator Group · 1 Intervention: Intensive lifestyle interventions (ILIs) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 4 and month 12

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,559 Previous Clinical Trials
2,765,723 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
318 Previous Clinical Trials
1,325,038 Total Patients Enrolled
Megha Shah, MDPrincipal InvestigatorEmory University

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
You need to be able to speak English. If you are in a pair, at least one person must speak English.
You are willing to sign a form saying you agree to participate in the study.
You can speak and understand English well.
You are 18 years old or older.

Frequently Asked Questions

Does this investigation still welcome new applicants?

"Affirmative. The information readily available on 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." - Anonymous Online Contributor

Unverified Answer

Is there a cap on the amount of participants involved in this experiment?

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.