PrediabetesGO-FARNCT07491653
Fiber mHealth Intervention for Prediabetes
A study testing GO-FAR in people with Prediabetes, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- GO-FAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Suspected eating disorder
- Current glucagon-like peptide-1 receptor agonist use
- Food allergies or intolerances
- Currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Campus
Tulsa, Oklahoma, 74135
Ashlea Braun, PhD, 567-240-1582, ashlea-braun@ouhsc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Prediabetes
- Being tested
- GO-FAR
- Keywords
- Diet, Young adults, Fiber, Diabetes
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO-FARBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fiber-focused intervention | Experimental | Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods Receives: Behavioral: GO-FAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment (as a measure of intervention feasibility)
Percentage of recruitment goal reached.
Measured: 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
Measured: 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: Measured at the end of the 3-month intervention
Secondary outcomes (3)
Dietary fiber intake
Measured using the automated self-administered 24-hour recall
Measured: Baseline, after-intervention (3-months), and after a 4-week observation period
Glycemic control (hemoglobin A1c [HbA1c])
Measured via point-of-care testing devices
Measured: Baseline and after the intervention (3 months)
Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR])
Measured via venous blood samples
Measured: Baseline and after-intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startAug 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm feasibility trial with pre/post assessments plus a 1-month observation period.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashlea Braun, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491653
- Sponsor's protocol ID
- 18705
- Acronym
- GO-FAR
- Status last verified
- May 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Examination of an Innovative mHealth-Based Dietary Fiber Intervention to Improve Outcomes in Young Adults With Prediabetes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07491653
- Acronym / sponsor ID
- GO-FAR / 18705
- Conditions
- Prediabetes
- Keywords
- Diet, Young adults, Fiber, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm feasibility trial with pre/post assessments plus a 1-month observation period.
| Arm | Type | Receives |
|---|---|---|
| Fiber-focused intervention | Experimental | Behavioral: GO-FARMobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Suspected eating disorder
- Current glucagon-like peptide-1 receptor agonist use
- Food allergies or intolerances
- Currently pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GO-FAR3-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. | Behavioural | Fiber-focused intervention |
Primary outcome
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.
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
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashlea Braun, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO-FAR in people with Prediabetes, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashlea Braun, PhD (918.660.3080, Ashlea-Braun@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (as a measure of intervention feasibility) (time frame: Evaluated at the end of the project period (2 years in total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.