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.
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
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.
University of Oklahoma Health Campus
Tulsa, Oklahoma, United States
RECRUITINGRecruitment (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)
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)
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
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
Glycemic control (hemoglobin A1c [HbA1c])
Measured via point-of-care testing devices
Time frame: Baseline and after the intervention (3 months)
Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR])
Measured via venous blood samples
Time frame: Baseline and after-intervention (3 months)
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