Glycemic Excursion Minimization (GEM) to Outshine Health Disparities

NCT06236581 | Recruiting

• 1 other identifier: 1974851
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Black; Continuous glucose monitoring; physical activity; carbohydrate

Outcome Measures

Primary Outcomes (1)

• Change from baseline on percent time in range from continuous glucose monitor at post-intervention

  Difference in percent of time in range (70-180 mg/dL) from continuous glucose monitor data. Change = post intervention week minus baseline week.

  Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks

Study Arms (2)

GEM Intervention

EXPERIMENTAL

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.

Behavioral: GEM Intervention

Waitlist

NO INTERVENTION

Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered.

Interventions

GEM Intervention BEHAVIORAL

Lifestyle coaching

GEM Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes
• capable of making dietary and physical activity changes

You may not qualify if:

• on insulin or secretagogue
• on medications that impede weight loss (e.g., prednisone)
• pregnant or planning pregnancy in the next 2 months
• no history of moderate to severe hypoglycemia

Sponsors & Collaborators

• Catherine Davis: lead
• University of Virginia: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Catherine L Davis, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine L Davis, PhD

CONTACT

706-721-4534; katie.davis@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial, intervention vs. waitlist

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: June 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)