Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
- Conditions
- Obesity
- Interventions
- Behavioral: Standard Weight Loss EducationBehavioral: Fiber Intervention
- Registration Number
- NCT06227494
- Lead Sponsor
- Oklahoma State University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 63
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Standard Weight Loss Education Standard Weight Loss Education Individuals in this arm will be given standard weight loss education Fiber Intervention + Standard Weight Loss Education Fiber Intervention Individuals in this arm will be given education on both fiber and standard weight loss Fiber Intervention + Standard Weight Loss Education Standard Weight Loss Education Individuals in this arm will be given education on both fiber and standard weight loss Fiber Intervention Fiber Intervention Individuals in this arm will be given instruction on how to increase fiber intake,
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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))
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.
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)
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)
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)
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
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
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)
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: 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)
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
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)
Trial Locations
- Locations (1)
Oklahoma State University
🇺🇸Stillwater, Oklahoma, United States