Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-06 @ 9:49 AM
Study NCT ID:
NCT02677792
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wellness and Weight Family Group Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Child-report questionnaire; sum of scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale'}, {'measure': 'Change in Child-Reported Total Health-Related Quality of Life', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Child-report; total score from Pediatric Quality of Life Inventory'}, {'measure': 'Change in Parent-Reported Total Health-Related Quality of Life', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Parent-report; total score from Pediatric Quality of Life Inventory'}, {'measure': 'Change in Child Psychological Functioning (Total Problems Subscale from CBCL)', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'parent-report; Child Behavior Checklist (CBCL) Total Problems Scale'}, {'measure': 'Change in Home Food Inventory Obesiogenic Food Availability Score', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Parent-reported'}, {'measure': 'Change in Total Parenting Competence', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale'}], 'primaryOutcomes': [{'measure': 'Change in Child Weight Status (BMIz)', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'BMIz calculated from measured child height and weight'}], 'secondaryOutcomes': [{'measure': 'Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Child-report questionnaire'}, {'measure': 'Change in Child Dietary Intake Total kcals from 24-hour dietary recall', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids'}, {'measure': 'Change in Child A1C Values', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'From child medical chart - testing completed as part of standard medical care'}, {'measure': 'Change in Child Glucose Values', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'From child medical chart - testing completed as part of standard medical care'}, {'measure': 'Change in Parent Weight', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Measured parent weight'}, {'measure': 'Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Parent-report questionnaire'}, {'measure': 'Change in Parent Dietary Intake Total kcals from 24-hour dietary recall', 'timeFrame': 'Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)', 'description': 'Parent-report 24-hour dietary recall assessed via ASA24-2014'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit\n2. child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)\n3. child or adolescent is accompanied by a parent or legal guardian\n4. participating child and parent speak and read English\n5. family agrees to attend group meetings at a medical clinic over a 3 month period\n\nExclusion Criteria:\n\n1. participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)\n2. child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)\n3. child or parent, according to parent report, in commercial weight loss program\n4. child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report\n5. parent and child do not speak and read English'}, 'identificationModule': {'nctId': 'NCT02677792', 'briefTitle': 'Wellness and Weight Family Group Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Wellness and Weight Family Group Project', 'orgStudyIdInfo': {'id': '#2015-0155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Family Intervention (BFI)', 'interventionNames': ['Behavioral: Behavioral Family Intervention (BFI)']}], 'interventions': [{'name': 'Behavioral Family Intervention (BFI)', 'type': 'BEHAVIORAL', 'description': 'Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).', 'armGroupLabels': ['Behavioral Family Intervention (BFI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Crystal S. Lim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Crystal Stack Lim', 'investigatorAffiliation': 'University of Mississippi Medical Center'}}}}