Clinical Trials Directory

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RecruitingNCT07491653

Fiber mHealth Intervention for Prediabetes

Preliminary Examination of an Innovative mHealth-Based Dietary Fiber Intervention to Improve Outcomes in Young Adults With Prediabetes: A Feasibility Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
University of Oklahoma · Academic / Other
Sex
All
Age
18 Years – 39 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGO-FAR3-month intervention combining multiple behavior change techniques (biofeedback, adding objects to the environment, instruction on how to perform the behavior), all focused on helping people at more fiber.

Timeline

Start date
2026-03-31
Primary completion
2028-07-01
Completion
2028-07-01
First posted
2026-03-24
Last updated
2026-03-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07491653. Inclusion in this directory is not an endorsement.