This clinical trial studies whether glucose-guided eating (GGE) can be used to lower chronic disease risk in adolescent and young adult (AYA) cancer survivors and postmenopausal women with prediabetes. Eating when the body does not need food is linked to weight gain and an increased risk of several chronic health conditions including type 2 diabetes. Teaching people to regulate their energy intake by self-monitoring blood sugar (glucose) levels to understand the difference between physical hunger and their physical desire to eat without hunger is a supported weight control strategy. GGE uses glucose monitoring as real-time feedback of short-term energy status to guide personalized decisions about when to eat, without additional dietary restrictions. Individuals following GGE self-monitor their glucose levels and are instructed to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below their personalized starting value. GGE may be an effective way to lower chronic disease risk in AYA cancer survivors and postmenopausal women with prediabetes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05998460.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Georgetown University HospitalStatus: Active
Contact: Susan Schembre
Phone: 202-444-2223
PRIMARY OBJECTIVES:
I. Test the feasibility and acceptability of the GGE intervention and companion GGE mobile app.
II. Quantify the preliminary effect of GGE on 12-week changes in insulin resistance (IR) and body weight.
SECONDARY OBJECTIVES:
I. Collect preliminary data on hypothesized mechanisms linking GGE to IR.
II. Explore the durability of intervention effects on 24-week changes in body weight.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo continuous glucose monitoring (CGM) for up to 10 days (week 0). Patients continue to undergo CGM and follow GGE by rating their perceived hunger level, type of hunger, and entering their glucose level within the GGE app and then receiving feedback about whether they should eat or wait and retry in 30-60 minutes every time they want to eat for 20 days (weeks 1-3) in the absence of unacceptable toxicity. Patients then follow GGE without CGM or the GGE app during weeks 4-12. Patients also receive tips, supportive messages, and rewards via the GGE app on study. Additionally, patients undergo blood and urine sample collection on study.
ARM II: Patients undergo CGM during weeks 0-3 in the absence of unacceptable toxicity. Additionally, patients undergo blood and urine sample collection on study.
After completion of study intervention, patients are followed up at week 24.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedStar Georgetown University Hospital
Principal InvestigatorSusan Schembre
