Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-01 @ 12:32 AM
Study NCT ID:
NCT01145833
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2010-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Guided Self-help for Families With an Overweight Child
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kboutelle@ucsd.edu', 'phone': '858-534-8037', 'title': 'Kerri Boutelle, Principal Investigator', 'organization': 'University of CA, San Diego Center for Healthy Eating and Activity Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Immediate Treatment Group', 'description': 'The immediate treatment group begins the 5-month treatment immediately after baseline assessment.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Delayed Treatment Group', 'description': 'The delayed treatment group serves as the control group.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Child BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Treatment Group', 'description': 'The immediate treatment group begins the 5-month treatment immediately after baseline assessment.'}, {'id': 'OG001', 'title': 'Delayed Treatment Group', 'description': 'The delayed treatment group serves as the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '25.17', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 months', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parent BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Treatment Group', 'description': 'The immediate treatment group begins the 5-month treatment immediately after baseline assessment.'}, {'id': 'OG001', 'title': 'Delayed Treatment Group', 'description': 'The delayed treatment group serves as the control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 months', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Treatment Group', 'description': 'The immediate treatment group begins the 5-month treatment immediately after baseline assessment.'}, {'id': 'FG001', 'title': 'Delayed Treatment Group', 'description': 'The delayed treatment group serves as the control group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Treatment Group', 'description': 'The immediate treatment group begins the 5-month treatment immediately after baseline assessment.'}, {'id': 'BG001', 'title': 'Delayed Treatment Group', 'description': 'The delayed treatment group serves as the control group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '10.5', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '1.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Child BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '24.4', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parent BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2010-06-14', 'resultsFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child BMI', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'Parent BMI', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'guided self help treatment', 'treatment method', 'overweight', 'overweight children and parents', 'families with overweight child', 'efficacy', 'body mass index', 'weight'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '7287977', 'type': 'RESULT', 'citation': 'Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based behavior modification programs. J Consult Clin Psychol. 1981 Oct;49(5):674-85. doi: 10.1037//0022-006x.49.5.674. No abstract available.'}, {'pmid': '10619533', 'type': 'RESULT', 'citation': 'Epstein LH, Kilanowski CK, Consalvi AR, Paluch RA. Reinforcing value of physical activity as a determinant of child activity level. Health Psychol. 1999 Nov;18(6):599-603.'}, {'pmid': '12224662', 'type': 'RESULT', 'citation': 'Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.'}, {'pmid': '11746298', 'type': 'RESULT', 'citation': 'Peterson CB, Mitchell JE, Engbloom S, Nugent S, Pederson Mussell M, Crow SJ, Thuras P. Self-help versus therapist-led group cognitive-behavioral treatment of binge eating disorder at follow-up. Int J Eat Disord. 2001 Dec;30(4):363-74. doi: 10.1002/eat.1098.'}, {'pmid': '8646260', 'type': 'RESULT', 'citation': 'Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.'}, {'pmid': '25181608', 'type': 'DERIVED', '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': 'DERIVED', '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 purpose of this study is to evaluate whether a home based program can teach parents and moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to manage their child's weight. The study uses manuals and involves a short visit to the clinic every other week.", 'detailedDescription': 'An estimated 4-5 million children between the ages of 6-17 in the United States are obese. Children who are obese are at an increased risk for many negative health consequences in childhood and in adulthood. In addition, these children are at an increased risk for psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing, verbal abuse and social isolation. Guided self-help offers an opportunity to provide empirically based programs to a larger amount of the target population. Once such treatment methods are available, it is possible that the guided self-help treatment for childhood obesity can be disseminated to primary care practitioners, psychologists, nurses, and health educators. Ultimately, the goal of this application is to develop a treatment protocol that can be used by clinics and lay health professionals to intervene with children who are overweight and their parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child between the ages of 8 \\& 12\n* an moderately overweight child with a BMI% between 85-97%\n* child has a parent willing to participate\n* child has a parent who can read English at a minimum of a 6th grade level\n* family who is willing to commit to treatment attendance and attendance at all assessments.\n\nExclusion Criteria:\n\n* Child psychiatric disorder diagnoses (based on parent report)\n* Child diagnoses of a serious current physical disease (such as diabetes)\n* Child who is taking medications that may impact their weight\n* Child with physical difficulties that limit the ability to exercise\n* Child with an active eating disorder\n* Child and parent will be moving out of the San Diego County before study completion\n* Child and/or parent has a modified diet due to religious or socially conscious reasons (such as Vegan, vegetarian)'}, 'identificationModule': {'nctId': 'NCT01145833', 'acronym': 'GSH', 'briefTitle': 'Guided Self-help for Families With an Overweight Child', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Guided Self-help Treatment for Families With an Overweight Child', 'orgStudyIdInfo': {'id': '081129'}, 'secondaryIdInfos': [{'id': '1R21DK080266-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21DK080266-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate treatment group', 'description': 'The immediate treatment group begins the 5-month treatment immediately after baseline assessment.', 'interventionNames': ['Other: Immediate Treatment Group']}, {'type': 'OTHER', 'label': 'Delayed Treatment Group', 'description': 'The delayed treatment group serves as the control group. This group starts treatment 5 months after the baseline assessment. No intervention is involved during this 5-month waiting period. After 5 months, the delayed group is assessed for the second time and then begins the 5-month treatment.', 'interventionNames': ['Other: Delayed Treatment Group']}], 'interventions': [{'name': 'Immediate Treatment Group', 'type': 'OTHER', 'description': 'The immediate treatment group starts the 5-month treatment right after baseline assessment.', 'armGroupLabels': ['Immediate treatment group']}, {'name': 'Delayed Treatment Group', 'type': 'OTHER', 'otherNames': ['Delayed Treatment Group (Control)'], 'description': 'The delayed treatment group does not start treatment immediately after the baseline assessment. This group serves as the control group, by not receiving any treatment for 5 months. After the 5 months, the delayed group participants are asked to come in for a second assessment that involves completion of surveys and measurement of height, weight, and physical activity level. After this assessment is completed, the delayed group participants can begin the 5-month treatment.', 'armGroupLabels': ['Delayed Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Center for Obesity and Health//Pediatrics Department', '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'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kerri Boutelle', 'investigatorAffiliation': 'University of California, San Diego'}}}}