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NCT Number: NCT07491653

Fiber mHealth Intervention for Prediabetes

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Campus

Tulsa, Oklahoma, 74135, United States

Location status: Recruiting

Location contact

Ashlea Braun, PhD

CONTACT

[email protected]

567-240-1582

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GO-FAR

Behavioral

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 outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. Glycemic control (hemoglobin A1c [HbA1c])

    Time frame: Baseline and after the intervention (3 months)

    Measured via point-of-care testing devices

  3. Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR])

    Time frame: Baseline and after-intervention (3 months)

    Measured via venous blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Ashlea Braun, PhD

CONTACT

[email protected]

918.660.3080

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: GO-FAR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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