Glycemic Excursion Minimization (GEM) to Outshine Health Disparities

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Catherine Davis
Study ID
NCT06236581
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GEM Intervention — BEHAVIORAL
    Lifestyle coaching

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline on percent time in range from continuous glucose monitor at post-intervention [ Time Frame: Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia Prevention InstituteAugustaGeorgia30912
Andre Soares, PT MS
706-721-4534
Catherine L Davis, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Georgia Prevention Institute· Augusta, GA

Related Studies