Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT03096132
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2017-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child weight loss', 'timeFrame': 'Change from baseline to month 6, 12 and 18', 'description': 'BMI; BMIz'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'Baseline to month 6, 12 and 18', 'description': 'Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.'}], 'secondaryOutcomes': [{'measure': 'Parent BMI', 'timeFrame': 'Change from baseline to month 6, 12 and 18', 'description': 'BMI'}, {'measure': 'Child Physical Activity - minutes of moderate-vigorous activity', 'timeFrame': 'Change from baseline to month 6, 12 and 18', 'description': 'Measured by accelerometer, minutes in Moderate to Vigorous physical activity'}, {'measure': 'Parent Physical Activity - minutes of moderate-vigorous activity', 'timeFrame': 'Change from baseline to month 6, 12 and 18', 'description': 'Measured by accelerometer, minutes in Moderate to Vigorous physical activity'}, {'measure': 'Child Nutrition-measured as servings of fruit and vegetables per day', 'timeFrame': 'Change from baseline to month 6, 12 and 18', 'description': 'Self-reported number of servings of fruits and vegetables consumed each day'}, {'measure': 'Parent Nutrition-measured as servings of fruit and vegetables per day', 'timeFrame': 'Change from baseline to month 6, 12 and 18', 'description': 'Self-reported number of servings of fruits and vegetables consumed each day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Overweight', 'Overeating', 'Body Mass Index', 'Treatment', 'Intervention', 'Family Based Therapy', 'Weight', 'Children'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '25181608', 'type': 'BACKGROUND', 'citation': 'Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2.'}, {'pmid': '23545372', 'type': 'BACKGROUND', 'citation': 'Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate whether a less intensive intervention, Guided Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness of both treatments will also be compared.', 'detailedDescription': 'The primary aim of this project is to determine whether gshFBT is non-inferior to FBT for childhood obesity on child weight loss. Four assessments will be conducted; baseline (month 0), month 6 (post-treatment), and at month 12 and month 18. Assessments will include the following for child and parent: anthropometry, physical activity, nutrition, and cost-effectiveness. Cost-effectiveness will be calculated from a societal perspective and a third party payor perspective. This program of research has the potential to advance the standard of practice for children who are overweight or obese by providing a less intensive but more cost-effective intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. An overweight child age 7-12, whose BMI is ≥ 85th percentile but does not meet criteria for severe obesity (i.e., BMI ≥120% of the 95th percentile or an absolute BMI ≥ 35 kg/m2 , whichever is lower for age and gender)\n2. The parent willing to participate can read English at a minimum of a 5th grade level\n3. Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm\n4. Child or parent is free from psychiatric illness than may affect participation;\n5. Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment\n6. Child is not taking medications that may impact their weight (unless medication dosage is stable and not for the purpose of impacting weight and appetite)'}, 'identificationModule': {'nctId': 'NCT03096132', 'briefTitle': 'FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Effect of Treatment Dose on Childhood Obesity', 'orgStudyIdInfo': {'id': '160289'}, 'secondaryIdInfos': [{'id': 'R01DK108686', 'link': 'https://reporter.nih.gov/quickSearch/R01DK108686', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Family Based Behavioral Treatment', 'description': 'The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a weekly group setting.', 'interventionNames': ['Behavioral: Family Based Behavioral Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Guided Self-Help Fam. Based Bx Treatment', 'description': 'The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a guided self-help manual.', 'interventionNames': ['Behavioral: Guided Self-Help Fam. Based Bx Treatment']}], 'interventions': [{'name': 'Family Based Behavioral Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['FBT'], 'description': 'Treatment includes 20 90 minute visits over 6 months which include 60 min parent and child separate groups and 30 min behavioral coaching. FBT includes information regarding nutrition and physical activity, as well as behavior therapy skills, including parenting skills, self-monitoring, problem solving skills, motivation systems, emotional regulation, stress management, stimulus control, and relapse prevention.', 'armGroupLabels': ['Family Based Behavioral Treatment']}, {'name': 'Guided Self-Help Fam. Based Bx Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['gshFBT'], 'description': 'Treatment includes 14 20 minute visits over 6 months. gshFBT is delivered to parent/child dyads and includes the same content in the FBT groups but it is provided in a manual. The 20-minute visits focus on clarifying information in the manuals, collecting weight and self-monitoring logs, and problem solving any barriers to implementation.', 'armGroupLabels': ['Guided Self-Help Fam. Based Bx Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Center for Healthy Eating and Activity Research (CHEAR)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Kerri Boutelle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kerri Boutelle', 'investigatorAffiliation': 'University of California, San Diego'}}}}