High-fiber mHealth program for young adults with prediabetes
Preliminary Examination of an Innovative mHealth-Based Dietary Fiber Intervention to Improve Outcomes in Young Adults With Prediabetes: A Feasibility Study
NA · University of Oklahoma · NCT07491653
This three-month phone-based program tests whether weekly home-delivered high-fiber foods, brief education, and continuous glucose monitor feedback can improve blood sugar control in young adults (18–39) with prediabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Tulsa, Oklahoma) |
| Trial ID | NCT07491653 on ClinicalTrials.gov |
What this trial studies
This single-arm feasibility trial enrolls adults aged 18–39 with prediabetes and collects baseline venous blood to measure insulin resistance. Participants complete a three-month fully mHealth intervention that provides high-fiber nutrition education, weekly home deliveries of high-fiber foods, and periodic continuous glucose monitor (CGM) use for biofeedback. After the intervention participants return for repeat blood testing of insulin resistance and then complete a one-month observation period with smartphone-based ecological momentary assessments. Outcomes focus on feasibility, changes in glycemic markers and insulin resistance, and real-world adherence to higher-fiber eating.
Who should consider this trial
Good fit: Ideal candidates are English-speaking young adults (18–39) living near the Tulsa metro with prediabetes by HbA1c, who can use a compatible smartphone and are not pregnant, breastfeeding, on GLP-1 agonists, or have eating disorders or disqualifying food allergies.
Not a fit: People with established diabetes, those pregnant or breastfeeding, individuals on GLP-1 receptor agonists, those with serious eating disorders or food restrictions, or anyone unable to use a smartphone or attend Tulsa visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could help lower blood sugar and improve insulin resistance through practical dietary changes delivered and reinforced via smartphones and CGM feedback.
How similar studies have performed: Separate research supports that higher dietary fiber and mHealth or CGM-based feedback can improve glycemic control, but combining home food delivery with CGM-based biofeedback in young adults with prediabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tulsa, Oklahoma
- University of Oklahoma Health Campus — Tulsa, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Ashlea Braun, PhD — University of Oklahoma
- Study coordinator: Ashlea Braun, PhD
- Email: Ashlea-Braun@ou.edu
- Phone: 918.660.3080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prediabetes, Diet, Young adults, Fiber, Diabetes