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This study is seeking to examine combinations of two different dietary interventions on cancer risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber for Improvement of Behavior, Eating, and Risk (FIBER) | Experimental |
| |
| Time Restricted Eating (TRE) | Experimental |
| |
| FIBER and TRE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating | Behavioral | 10-hour Time Restricted Eating (TRE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dietary fiber intake | Dietary fiber intake as reported on 3-day diet records and analyzed according to Nutrition Data System for Research; reported as a mean intake over three days in grams per day | Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass/weight | Body mass/weight will be measured in kilograms | Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months) |
| Blood pressure | Blood pressure (systolic and diastolic) will be measured at each time frame (in millimeters of mercury [mmHg]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences | Columbus | Ohio | 43230 | United States |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D015431 | Weight Loss |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Group education | Behavioral | Group education about dietary fiber |
|
| Counseling | Behavioral | Counseling and motivational interviewing to promote uptake of diet changes |
|
| Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months) |
| Blood-based measures of inflammation | Venous blood samples will be collected and analyzed for inflammatory markers: Granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon-gamma (IFN-γ), interleukin-1 beta (IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α). | Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months) |
| Blood-based measures of oxidative stress | Venous blood samples will be collected and analyzed for measures of oxidative stress, including reactive oxygen species and lipid peroxidation | Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months) |
| Blood-based measures of insulin resistance | Insulin resistance will be measured via assessment of insulin and glucose in venous blood samples, and used to assess Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months) |
| Affect | Self-reported affect will be assessed using ecological momentary assessment, delivered via cell phone | Daily for three months |
| Sleep | Sleep will be measured via Fitbits, assessed as mean minutes/night | Daily for three months |
| Physical Activity | Physical activity will be measured via Fitbits, assessed as mean steps/day | Daily for three months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |