Prediabetes
Conditions
Keywords
Diet, Young adults, Fiber, Diabetes
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.
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.
Interventions
BEHAVIORALGO-FAR
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.
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Masking not possible as single arm
Intervention model description
Single arm feasibility trial with pre/post assessments plus a 1-month observation period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment (as a measure of intervention feasibility) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Dietary fiber intake | Baseline, after-intervention (3-months), and after a 4-week observation period | Measured using the automated self-administered 24-hour recall |
| Glycemic control (hemoglobin A1c [HbA1c]) | Baseline and after the intervention (3 months) | Measured via point-of-care testing devices |
| Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]) | Baseline and after-intervention (3 months) | Measured via venous blood samples |
Countries
United States
Contacts
CONTACTAshlea Braun, PhD
PRINCIPAL_INVESTIGATORAshlea Braun, PhD
University of Oklahoma
Outcome results
None listed