Glucose-Guided Eating Pilot

NCT ID: NCT05998460

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-08-31

Brief Summary

This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).

Detailed Description

The primary objectives of the study are to (1) test the feasibility and acceptability of the GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE on 12-week changes in insulin resistance (IR) and body weight.

The secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking GGE to IR and (2) explore the durability of intervention effects on 24-week changes in body weight.

Conditions

Postmenopausal; Prediabetes; Adolescent and Young Adult (AYA) Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GGE with CGM

Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.

Group Type: EXPERIMENTAL

Glucose-Guided Eating with CGM

Intervention Type: BEHAVIORAL

The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.

CGM only

Intervention Type: OTHER

Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

CGM only

Participants randomized to the control arm will only wear a CGM.

Group Type: ACTIVE_COMPARATOR

CGM only

Intervention Type: OTHER

Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

Interventions

Glucose-Guided Eating with CGM

The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.

Intervention Type: BEHAVIORAL

CGM only

Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

All:

1. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2

2. Willing to use a continuous glucose monitor

3. Own smartphone that is compatible with Dexcom CGM.

4. Willingness to commute to GUMC for in-person study visits

5. No active cancer (except for nonmelanoma skin cancer)

6. Less than 5 lbs. weight change in previous 3 months

7. Proficient in speaking and reading English

Postmenopausal women with pre-diabetes:

8. Age 18 years and older

9. Diagnosed as having prediabetes.

10. HbA1c (within 3 months) between 5.7% and 6.4%

11. Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)

AYA cancer survivors:

12. Current age 21-39 years

13. Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously

Exclusion Criteria

1. Unable or unwilling to provide informed consent

2. Clinical history of type 1 or type 2 diabetes

3. Currently receiving anti-diabetics (e.g., insulin, GLP1), oral hypoglycemic agent (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers, hydroxyurea, atypical antipsychotic agents (i.e., Olanzapine, Aripiprazole) or systemic progestin-only contraceptives

4. Current or past history of an eating disorder

5. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)

6. Have any contraindications for CGM, including: severe allergy to surgical adhesive, being on dialysis, receiving diathermy treatment, or scheduled CT scan or MRI during wear period

7. Growth hormone deficiency, hypoadrenal function, or hypopituitary function

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan M Schembre

Role: PRINCIPAL_INVESTIGATOR

Georgetown's Lombardi Comprehensive Cancer Center

Nina Kadan-Lottick

Role: PRINCIPAL_INVESTIGATOR

Georgetown's Lombardi Comprehensive Cancer Center

Central Contacts

Princess M Georges

Role: CONTACT

pg763@georgetown.edu

2026872117

Megan Roy

Role: CONTACT

mr1839@georgetown.edu

References

Schembre SM, Jospe MR, Giles ED, Sears DD, Liao Y, Basen-Engquist KM, Thomson CA. A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial. Nutrients. 2021 Dec 16;13(12):4508. doi: 10.3390/nu13124508.

Reference Type: BACKGROUND

PMID: 34960058 (View on PubMed)

Schembre SM, Jospe MR, Bedrick EJ, Li L, Brewster AM, Levy E, Dirba DD, Campbell M, Taylor RW, Basen-Engquist KM. Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study. Cancer Prev Res (Phila). 2022 Mar 1;15(3):193-201. doi: 10.1158/1940-6207.CAPR-21-0298.

Reference Type: BACKGROUND

PMID: 34893531 (View on PubMed)

Other Identifiers

STUDY00006573

Identifier Type: -

Identifier Source: org_study_id