Glycemic Excursion Minimization (GEM) to Outshine Health Disparities

NCT ID: NCT06236581

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, intervention vs. waitlist
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

GEM Intervention

Intervention Type BEHAVIORAL

Lifestyle coaching

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GEM Intervention

Lifestyle coaching

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Catherine Davis

OTHER

Sponsor Role lead

Responsible Party

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Catherine Davis

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Catherine L Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Georgia Prevention Institute

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine L Davis, PhD

Role: CONTACT

706-721-4534

Facility Contacts

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Andre Soares, PT MS

Role: primary

706-721-4534

Other Identifiers

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1974851

Identifier Type: -

Identifier Source: org_study_id

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