Nctid:
NCT06227494
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "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"=>"2024-03", "completionDateStruct"=>{"date"=>"2026-02-28", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-29", "studyFirstSubmitDate"=>"2023-07-28", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-02", "type"=>"ACTUAL"}, "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"=>{"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"}}}}
