Fiber mHealth Intervention for Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GO-FAR.
- Who it may be relevant to
- Registry conditions: Prediabetes. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preliminary Examination of an Innovative mHealth-Based Dietary Fiber Intervention to Improve Outcomes in Young Adults With Prediabetes: A Feasibility Study
Overview
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.
Interventions
- Behavioral GO-FAR
3-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.
Primary outcome measures
- Recruitment (as a measure of intervention feasibility) [Time frame: Evaluated at the end of the project period (2 years in total)]
- Retention of participants (as a measure of feasibility) [Time frame: Retention will be based on time retained in the study over a period of approximately 5 months (from enrollment to completion of follow-up data collection)]
- Acceptability (as a measure of feasibility) [Time frame: Measured at the end of the 3-month intervention]
Secondary outcome measures (3)
- Dietary fiber intake [Time frame: Baseline, after-intervention (3-months), and after a 4-week observation period]
- Glycemic control (hemoglobin A1c [HbA1c]) [Time frame: Baseline and after the intervention (3 months)]
- Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]) [Time frame: Baseline and after-intervention (3 months)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Oklahoma Health Campus — Tulsa
Identifiers
NCT: NCT07491653 · 18705