Glycemic Excursion Minimization (GEM) to Outshine Health Disparities: RCT

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• type 2 diabetes

• capable of making dietary and physical activity changes

Locations
United States
Georgia
Georgia Prevention Institute
RECRUITING
Augusta
Contact Information
Primary
Catherine L Davis, PhD
katie.davis@augusta.edu
706-721-4534
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2024-12
Participants
Target number of participants: 25
Treatments
Experimental: GEM Intervention
A lifestyle coach will deliver the GEM intervention over 4 weeks in person and/or virtually (synchronously) to permit interaction with participants. A pocket-sized manual will be provided with 4 units corresponding to session topics, and diary pages to record glucose responses to food and physical activity (PA). Session 1: Introduce GEM, identify personal motivation, learn about foods that cause glucose to go high (high glycemic load (GL) foods) and those that do not (low GL foods), learn how physical activity affects glucose, and begin monitoring how these choices affect glucose. Session 2: Replacement, substitution, and portion control to reduce consumption of high GL foods. Session 3: Increasing PA and reducing sedentary behavior, esp. after a meal. Session 4: Ways to continue lifestyle changes over a lifetime, handle relapses, and thank loved ones for their support. Text message reminders may be sent to participants between sessions to prompt diary entries and for encouragement.
No_intervention: Waitlist
Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered.
Related Therapeutic Areas
Sponsors
Leads: Catherine Davis
Collaborators: University of Virginia, University of Colorado, Denver

This content was sourced from clinicaltrials.gov