Health TrialsbyHealthPanel

Fiber mHealth Intervention for Prediabetes

ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pre-diabetes based on HbA1c

Young adult, aged 18-39 years

Reside near Tulsa metro area

Ability to access/use a compatible smartphone

Disqualifiers

Suspected eating disorder

Current glucagon-like peptide-1 receptor agonist use

Food allergies or intolerances

Currently pregnant or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Fiber-focused interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment (as a measure of intervention feasibility)

Percentage of recruitment goal reached.

Time frame
Evaluated at the end of the project period (2 years in total)
2

Retention of participants (as a measure of feasibility)

Percentage of enrolled participants who remain in the study throughout the intervention period

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)
3

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.

Time frame
Measured at the end of the 3-month intervention

Secondary outcomes

1

Dietary fiber intake

Measured using the automated self-administered 24-hour recall

Time frame
Baseline, after-intervention (3-months), and after a 4-week observation period
2

Glycemic control (hemoglobin A1c [HbA1c])

Measured via point-of-care testing devices

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

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

Measured via venous blood samples

Time frame
Baseline and after-intervention (3 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov
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