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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber-focused intervention | Experimental | Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary fiber intake | Measured using the automated self-administered 24-hour recall | Baseline, after-intervention (3-months), and after a 4-week observation period |
| Glycemic control (hemoglobin A1c [HbA1c]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashlea Braun, PhD | Contact | 918.660.3080 | Ashlea-Braun@ou.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashlea Braun, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Campus | Recruiting | Tulsa | Oklahoma | 74135 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014214 | Triallate |
| ID | Term |
|---|---|
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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Single arm feasibility trial with pre/post assessments plus a 1-month observation period.
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Masking not possible as single arm
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Measured via point-of-care testing devices
| Baseline and after the intervention (3 months) |
| Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]) | Measured via venous blood samples | Baseline and after-intervention (3 months) |
| D009930 |
| Organic Chemicals |
| D013457 | Sulfur Compounds |