Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT06227494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2024-01-24', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Measure of body weight/mass'}], 'secondaryOutcomes': [{'measure': 'Body composition (fat mass, lean mass)', 'timeFrame': 'Measured at baseline (time 1, month 0) and post-observation (time 3, month 27)', 'description': 'Dual x-ray absorptiometry (DEXA) scans'}, {'measure': 'Fecal short chain fatty acids', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Taken from fecal samples collected at home'}, {'measure': 'Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Will include measures of diversity, abundance, etc.'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Measured via blood samples (unit= milligram/deciliter (mg/dL))'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27)', 'description': 'Measured via blood samples (unit=mg/dL)'}, {'measure': 'Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Taken from 3 day diet records (score range=0-100, higher=better diet quality)'}, {'measure': 'Three-Factor Eating Questionnaire', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': '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'}, {'measure': 'Implicit Association Test', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Represented with a total D variable (No range, but more negative = greater preference for unprocessed food)'}, {'measure': 'Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation'}, {'measure': 'Executive Function: Tower Test (Delis-Kaplan Executive Function System)', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Total Achievement Score (range=0-30, higher = higher executive function)'}, {'measure': 'Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Scaled inhibition/switching scores (score range=1-19, higher = higher executive function)'}, {'measure': 'Skin Carotenoid scores measured via the Veggie Meter', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Veggie Meter; score range 0-800 (higher=greater skin carotenoids (i.e., consumption of more fruits/vegetables)'}, {'measure': 'High-density lipoprotein (HDL) cholesterol', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Measured via blood samples (unit=mg/dL)'}, {'measure': 'Low-density lipoprotein (LDL) cholesterol', 'timeFrame': 'Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)', 'description': 'Measured via blood samples (unit=mg/dL)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* Dietary fiber intake ≤25 grams/day\n* Self-reported BMI ≥30 kg/m2\n* Willingness to attend in-person education sessions\n* Willingness to avoid taking supplemental digestive aids (e.g., alpha-galactosidase (Beano®),\n* Willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Metabolic, digestive, or allergic conditions or reactions that preclude consumption of whole food or food groups (e.g., irritable bowel syndrome, diverticulosis)\n* History of gastric bypass surgery\n* Currently taking glucagon like glucagon-like peptide-1 (GLP-1) Receptor Agonists\n* Self-reported history of a diagnosed eating disorder\n* Chronic disease (other than obesity)\n* Pregnancy or lactation\n* Use of tobacco or electronic smoking products\n* Taking a pre-, pro-, or syn-biotic supplement\n* Enrollment in another weight loss or diet intervention'}, 'identificationModule': {'nctId': 'NCT06227494', 'briefTitle': 'Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?', 'orgStudyIdInfo': {'id': 'IRB-23-59-STW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber Intervention', 'description': 'Individuals in this arm will be given instruction on how to increase fiber intake,', 'interventionNames': ['Behavioral: Fiber Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Weight Loss Education', 'description': 'Individuals in this arm will be given standard weight loss education', 'interventionNames': ['Behavioral: Standard Weight Loss Education']}, {'type': 'EXPERIMENTAL', 'label': 'Fiber Intervention + Standard Weight Loss Education', 'description': 'Individuals in this arm will be given education on both fiber and standard weight loss', 'interventionNames': ['Behavioral: Fiber Intervention', 'Behavioral: Standard Weight Loss Education']}], 'interventions': [{'name': 'Fiber Intervention', 'type': 'BEHAVIORAL', 'description': 'Group education and phone-based motivational interviewing to gradually increase dietary fiber consumption to 30-35 grams per day.', 'armGroupLabels': ['Fiber Intervention', 'Fiber Intervention + Standard Weight Loss Education']}, {'name': 'Standard Weight Loss Education', 'type': 'BEHAVIORAL', 'description': 'Group education and phone-based motivational interviewing to promote current evidence-based behaviors to promote weight loss via achieving a negative energy balance.', 'armGroupLabels': ['Fiber Intervention + Standard Weight Loss Education', 'Standard Weight Loss Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}