Fiber mHealth Intervention for Prediabetes

NCT07491653 | Recruiting

• 1 other identifier: 18705
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes

Keywords

Diet; Young adults; Fiber; Diabetes

Outcome Measures

Primary Outcomes (3)

• Recruitment (as a measure of intervention feasibility)

  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)

  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)

• Acceptability (as a measure of feasibility)

  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

Secondary Outcomes (3)

• Dietary fiber intake

  Baseline, after-intervention (3-months), and after a 4-week observation period

• Glycemic control (hemoglobin A1c [HbA1c])

  Baseline and after the intervention (3 months)

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

  Baseline and after-intervention (3 months)

Study Arms (1)

Fiber-focused intervention

EXPERIMENTAL

Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods

Behavioral: GO-FAR

Interventions

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.

Fiber-focused intervention

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Suspected eating disorder
• Current glucagon-like peptide-1 receptor agonist use
• Food allergies or intolerances
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Campus

Tulsa, Oklahoma, 74135, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus

Interventions

Triallate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sulfur Compounds

Study Officials

• Ashlea Braun, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashlea Braun, PhD

CONTACT

918.660.3080; Ashlea-Braun@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking not possible as single arm
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm feasibility trial with pre/post assessments plus a 1-month observation period.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 24, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)