Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01698606
Status:
TERMINATED
Last Update Posted:
2019-05-29
First Post:
2012-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in parental BMI (kg/m2)', 'timeFrame': 'Baseline, 3, 6, 9, 12 months', 'description': 'Assessment of change in BMI of the caregiver primary attending the intervention with the child.'}], 'primaryOutcomes': [{'measure': 'BMI z-score', 'timeFrame': 'Baseline, 3, 6, 9, 12 months', 'description': 'Change in BMI z-score'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life Scores (PedsQL 4.0)', 'timeFrame': 'Baseline, 3, 6, 9, 12 months', 'description': 'Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).'}, {'measure': 'Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)', 'timeFrame': 'Baseline, 3, 6, 9, 12 months'}, {'measure': 'Change in parent-reported daily screen-time (TV, computer)', 'timeFrame': 'Baseline, 3, 6, 9, 12 months', 'description': 'Parent-reported daily screen-time, estimated to the nearest 15 minutes.'}, {'measure': 'Change in fruit & vegetable consumption assessed by 3-day food records', 'timeFrame': 'Baseline, 3, 6, 9, 12 months'}, {'measure': 'Change in dairy-product consumption assessed by 3-day food records', 'timeFrame': 'Baseline, 3, 6, 9, 12 months'}, {'measure': 'Change in grain-product consumption assessed by 3-day food records', 'timeFrame': 'Baseline, 3, 6, 9, 12 months'}, {'measure': 'Change in consumption of sugar-sweetened beverages assessed by 3-day food records', 'timeFrame': 'Baseline, 3, 6, 9, 12 months'}, {'measure': 'Change in percent overBMI', 'timeFrame': 'Baseline, 3, 6, 9, 12 months', 'description': 'Percent overBMI is the percentage above the 50th percentile of BMI for the respective age and gender \\[(BMI-BMI at 50th percentile)\\]/BMI at 50th percentile\\]\\*100'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood obesity', 'multidisciplinary', 'preschool children', 'community-based', 'lifestyle intervention', 'family-centered'], 'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': "In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants' degree of overweight (BMI z-score) and in improving quality of life.\n\nIn the final phase (phase 3), participating children will be randomized to either receiving a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6 months later (control or wait list arm), in order to generate more robust effectiveness data. Participants will receive an additional free 6-month YMCA membership while participating in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2-6 on study entry with primary overweight or obesity, BMI =\\> 85th percentile for age and sex on 2010 WHO Growth Charts for Canada\n* Family meets Readiness for change criteria, contemplation or higher stage, according to Prochaskas Transtheoretical Model.\n* At least one parent/caregiver committed to attend all the program sessions with the child\n* Parent/caregiver is agreeing to complete the study questionnaires at the required time points\n\nExclusion Criteria:\n\n* Chronic medical conditions potentially impacting program participation or associated with a potentially increased risk in participation (e.g. type 1 diabetes mellitus, heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical, developmental or psychological disabilities that could limit extent of study participation\n* Regular use of medications that could limit extent of study participation\n* Other concurrent or recently (last 12 months)received obesity treatment\n* Inability to read, speak, and/or verbally understand English\n* Living outside of the greater London, Ontario, area'}, 'identificationModule': {'nctId': 'NCT01698606', 'acronym': 'FOR HEALTH', 'briefTitle': 'FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience for Overweight and Obese Preschool Children and Their Families - a Pilot Trial.', 'orgStudyIdInfo': {'id': '103011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Secondary lifestyle intervention arm', 'description': '6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1.', 'interventionNames': ['Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Primary lifestyle intervention arm', 'description': 'First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling', 'interventionNames': ['Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling']}], 'interventions': [{'name': 'Multidisciplinary, family-centered lifestyle intervention with behavioral counseling', 'type': 'BEHAVIORAL', 'description': 'Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.', 'armGroupLabels': ['Primary lifestyle intervention arm', 'Secondary lifestyle intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital, London Health Sciences Centre, University of Western Ontario", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Dirk E. Bock, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western Ontario, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dirk Bock', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}