Fiber mHealth Intervention for Prediabetes
Purpose
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.
Condition
- Prediabetes
Eligibility
- Eligible Ages
- Between 18 Years and 39 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single arm feasibility trial with pre/post assessments plus a 1-month observation period.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- Masking not possible as single arm
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Fiber-focused intervention |
Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods |
|
Recruiting Locations
Tulsa, Oklahoma 74135
More Details
- Status
- Recruiting
- Sponsor
- University of Oklahoma
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 helping them eat more fiber. They 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, they will return for repeat assessment of insulin resistance. After that repeat assessment, they will do a one-month observation period using cell phone-based ecological momentary assessments.