Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALFiber Intervention
Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.
BEHAVIORALStandard Weight Loss Education
Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.
Sponsors
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years of age * Dietary fiber intake ≤25 grams/day * Self-reported BMI ≥30 kg/m2 * Willingness to attend in-person education sessions * Willingness to avoid taking supplemental digestive aids (e.g., alpha-galactosidase (Beano®), * Willingness to provide informed consent.
Exclusion criteria
* Metabolic, digestive, or allergic conditions or reactions that preclude consumption of whole food or food groups (e.g., irritable bowel syndrome, diverticulosis) * History of gastric bypass surgery * Currently taking glucagon like glucagon-like peptide-1 (GLP-1) Receptor Agonists * Self-reported history of a diagnosed eating disorder * Chronic disease (other than obesity) * Pregnancy or lactation * Use of tobacco or electronic smoking products * Taking a pre-, pro-, or syn-biotic supplement * Enrollment in another weight loss or diet intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Measure of body weight/mass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal short chain fatty acids | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Taken from fecal samples collected at home |
| Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Will include measures of diversity, abundance, etc. |
| Total Cholesterol | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Measured via blood samples (unit= milligram/deciliter (mg/dL)) |
| Fasting blood glucose | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27) | Measured via blood samples (unit=mg/dL) |
| Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Taken from 3 day diet records (score range=0-100, higher=better diet quality) |
| Three-Factor Eating Questionnaire | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | 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 |
| Body composition (fat mass, lean mass) | Measured at baseline (time 1, month 0) and post-observation (time 3, month 27) | Dual x-ray absorptiometry (DEXA) scans |
| Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation |
| Executive Function: Tower Test (Delis-Kaplan Executive Function System) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Total Achievement Score (range=0-30, higher = higher executive function) |
| Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System) | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Scaled inhibition/switching scores (score range=1-19, higher = higher executive function) |
| Skin Carotenoid scores measured via the Veggie Meter | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Veggie Meter; score range 0-800 (higher=greater skin carotenoids (i.e., consumption of more fruits/vegetables) |
| High-density lipoprotein (HDL) cholesterol | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Measured via blood samples (unit=mg/dL) |
| Low-density lipoprotein (LDL) cholesterol | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Measured via blood samples (unit=mg/dL) |
| Implicit Association Test | Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27) | Represented with a total D variable (No range, but more negative = greater preference for unprocessed food) |
Countries
United States
Outcome results
None listed