Fiber mHealth Intervention for Prediabetes (GO-FAR)

University of Oklahoma (OU)

Status: Enrolling

Conditions: Prediabetes

Treatments: Behavioral: GO-FAR

Study type: Interventional

Funder types: Other

Identifiers

NCT07491653

18705

Details and patient eligibility

About

This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber foods, and use of continuous glucose monitors.

Full description

This is a single-arm trial enrolling young adults (aged 18-39) with prediabetes (based on hemoglobin A1c). Enrolled individuals will complete baseline data collection in person to assess insulin resistance (venous blood samples). Enrolled individuals will then complete a three-month fully-mHealth based intervention focused exclusively on promoting greater fiber intake. Participants will receive weekly home-delivered shipments of high fiber foods and wear a continuous glucose monitor at two time points as a form of biofeedback. After the three months, participants will return for repeat assessment of insulin resistance. After that repeat assessment, participants will do a one-month observation period using cell phone-based ecological momentary assessments.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-diabetes based on HbA1c
• Young adult, aged 18-39 years
• Reside near Tulsa metro area
• Ability to access/use a compatible smartphone
• Proficient in English

Exclusion criteria

• Suspected eating disorder
• Current glucagon-like peptide-1 receptor agonist use
• Food allergies or intolerances
• Currently pregnant or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Fiber-focused intervention

Experimental group

Description:

Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods

Treatment:

Behavioral: GO-FAR