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The overall objective of this three-arm randomized controlled trial is to compare a dietary fiber-focused behavioral intervention to standard weight loss education for improving eating-related behavior and cognition, weight, and metabolic markers of chronic disease risk in a population of adults with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber Intervention | Experimental | Individuals in this arm will be given instruction on how to increase fiber intake, |
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| Standard Weight Loss Education | Active Comparator | Individuals in this arm will be given standard weight loss education |
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| Fiber Intervention + Standard Weight Loss Education | Experimental | Individuals in this arm will be given education on both fiber and standard weight loss |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber Intervention | Behavioral | Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Measure of body weight/mass | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition (fat mass, lean mass) | Dual x-ray absorptiometry (DEXA) scans | Measured at baseline (time 1, month 0) and post-observation (time 3, month 27) |
| Fecal short chain fatty acids | Taken from fecal samples collected at home |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma State University | Stillwater | Oklahoma | 74078 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard Weight Loss Education | Behavioral | Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance. |
|
| Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing | Will include measures of diversity, abundance, etc. | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Total Cholesterol | Measured via blood samples (unit= milligram/deciliter (mg/dL)) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Fasting blood glucose | Measured via blood samples (unit=mg/dL) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27) |
| Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020) | Taken from 3 day diet records (score range=0-100, higher=better diet quality) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Three-Factor Eating Questionnaire | Resulting scores in uncontrolled eating (range=9-36), cognitive restraint (range=3-12), and emotional eating (range=6-24); higher scores indicate more of that particular eating behavior | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Implicit Association Test | Represented with a total D variable (No range, but more negative = greater preference for unprocessed food) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale | Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Executive Function: Tower Test (Delis-Kaplan Executive Function System) | Total Achievement Score (range=0-30, higher = higher executive function) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System) | Scaled inhibition/switching scores (score range=1-19, higher = higher executive function) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Skin Carotenoid scores measured via the Veggie Meter | Veggie Meter; score range 0-800 (higher=greater skin carotenoids (i.e., consumption of more fruits/vegetables) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| High-density lipoprotein (HDL) cholesterol | Measured via blood samples (unit=mg/dL) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| Low-density lipoprotein (LDL) cholesterol | Measured via blood samples (unit=mg/dL) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |