Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-27 @ 8:02 PM
Study NCT ID:
NCT00063050
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2003-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoporosis Prevention: Changes to Exercise and Diet in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-14', 'studyFirstSubmitDate': '2003-06-19', 'studyFirstSubmitQcDate': '2003-06-19', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DXA - at baseline and 9 months'}, {'measure': 'Nutrient Intake Interview - at baseline, 3, 9 and 12 months'}, {'measure': 'Physical Activity Recall - at baseline, 3, 9 and 12 months'}, {'measure': 'Strength/Fitness measures - at baseline, 3, 9 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone density', 'Children', 'Adolescents', 'Behavior', 'Health education', 'Health promotion', 'Physical fitness', 'Diet', 'Parent training', 'Injury control'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Schmitz KE, Hovell MF, Nichols JF, Irvin VL, Keating K, Simon GM, Gehrman C, Jones KL. Validation study of adolescents' puberty self-assessments. Journal of Early Adolescence 2004; 24(4): 357-384."}, {'type': 'BACKGROUND', 'citation': 'Nichols JF, Irvin V, Schmitz KE, Hovell MF. Body Composition and Fat Distribution in Non-Hispanic White and Hispanic Pre-Adolescents. Int J of Body Comp Res 6(1):9-16, 2008.'}, {'pmid': '19928484', 'type': 'RESULT', 'citation': "Hovell MF, Nichols JF, Irvin VL, Schmitz KE, Rock CL, Hofstetter CR, Keating K, Stark LJ. Parent/Child training to increase preteens' calcium, physical activity, and bone density: a controlled trial. Am J Health Promot. 2009 Nov-Dec;24(2):118-28. doi: 10.4278/ajhp.08021111."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether educating parents about health and behavior management techniques will increase physical activity, calcium intake, fitness, and bone density in their children.', 'detailedDescription': "In recent years, osteoporosis has become a major public health problem in the United States. Osteoporosis can best be prevented by optimizing bone mineral gain and reducing bone loss. Because the rate of bone development reaches its peak during adolescence, fostering bone health in childhood is of critical importance. Although there have been many studies of exercise and nutritional factors that influence bone mass in adults, few randomized, prospective studies have been conducted in children. This study will determine whether parent training is effective in increasing children's calcium intake, strength, and frequency of aerobic exercise.\n\nFamilies will be randomly assigned to either the physical activity and nutrition intervention group or to the injury prevention control group. Families in both groups will undergo training during 9 weekly classes. The intervention training will emphasize health topics, principles of behavior, and contingency management techniques. Post-training coaching procedures will be provided periodically for 9 months. Coaching procedures will assist parents with problem solving and help them refine and maintain parenting skills. All families will be assessed prior to training and at Months 3, 9, and 12. Outcome measures will include 24-hour recall estimates of change in diet and change in physical activity. Total bone calcium, bone density, body composition, and skeletal age will also be assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Participates in organized sports less than 3 days a week and less than 9 months per year\n* Parent willing to attend weekly training sessions\n\nExclusion Criteria\n\n* Serious medical illness\n* Spends less than 4 days a week with the parent willing to attend classes\n* Body mass index \\> 32'}, 'identificationModule': {'nctId': 'NCT00063050', 'briefTitle': 'Osteoporosis Prevention: Changes to Exercise and Diet in Children', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Healthy Children Healthy Families', 'orgStudyIdInfo': {'id': 'R01HD037749', 'link': 'https://reporter.nih.gov/quickSearch/R01HD037749', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Physical activity and nutrition intervention', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Melbourne F. Hovell, Ph.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of CBEACH, Distinguished Professor of Public Health', 'investigatorFullName': 'Melbourne Hovell', 'investigatorAffiliation': 'San Diego State University'}}}}