Fiber mHealth Intervention for Prediabetes (GO-FAR)

May 28, 2026 updated by: University of Oklahoma

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Recruiting
        • University of Oklahoma Health Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber-focused intervention
Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability (as a measure of feasibility)
Time Frame: Measured at the end of the 3-month intervention
Participants will rate their perceived acceptability of the intervention using a 5-point Likert scale question ("How would you rate this study intervention as a whole?" rated as Poor, Fair, Good, Very Good, Excellent.
Measured at the end of the 3-month intervention
Recruitment (as a measure of intervention feasibility)
Time Frame: Evaluated at the end of the project period (2 years in total)
Percentage of recruitment goal reached.
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)
Percentage of enrolled participants who remain in the study throughout the intervention period
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary fiber intake
Time Frame: Baseline, after-intervention (3-months), and after a 4-week observation period
Measured using the automated self-administered 24-hour recall
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)
Measured via point-of-care testing devices
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)
Measured via venous blood samples
Baseline and after-intervention (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Ashlea Braun, PhD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18705

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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