Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT01974102
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2013-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Family Based Mindfulness Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rajita.sinha@yale.edu', 'phone': '2038592840', 'title': 'Dr. Rajita Sinha', 'organization': 'YALE UNIVERSITY SCHOOL OF MEDICINE'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Limitations of this study include the small sample size, limited data on the mothers due to participants' time restraints and preference, and short intervention duration."}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Not different than clinicaltrials.gov definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Lifestyle', 'description': 'This group will receive attendance control weekly with attendance in a group to watch a relaxing video and generate discussion.\n\nLifestyle counseling: Weekly nutritional and physical activity counseling.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prevention Intervention', 'description': 'Active group will receive 8 weeks of parenting mindfully for health (PMH) plus nutrition and physical activity (N) counseling\n\nLifestyle counseling: weekly Nutritional and physical activity counseling.\n\nMindfulness Based Parenting Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle', 'description': 'Session attendance in Control group'}, {'id': 'OG001', 'title': 'Prevention Intervention', 'description': 'Session Attendance in Mindfulness based Intervention group'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.015', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Attendance rates (average number of sessions) were compared across groups.', 'unitOfMeasure': 'Sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BMI Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle', 'description': 'Change in Child BMI Percentile from Post- to Pre- treatment in Control group'}, {'id': 'OG001', 'title': 'Prevention Intervention', 'description': 'Change in Child BMI Percentile from Post- to Pre- treatment in Mindfulness based Intervention group'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '16.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'A comparison between groups to determine the impact of the intervention on BMI percentile.', 'unitOfMeasure': 'BMI percentile change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Children were assessed Pre and Post intervention for weight and height to determine BMI percentiles'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lifestyle', 'description': 'Both active and control groups will receive counseling on nutrition and physical activity.\n\nLifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.'}, {'id': 'FG001', 'title': 'Prevention Intervention', 'description': 'Active group will receive 8 weeks of mindfulness based parenting stress intervention\n\nLifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.\n\nMindfulness Based Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'In Phase 1, 20 parent-child dyads started assessments,17 continued post baseline and provided feedback for initial pilot/development phase of PMH+N and C+N interventions. In Phase 2, forty-two parent-preschooler dyads were randomly assigned to receive either the 8-week PMH+N or C+N intervention. Thirty-eight dyads started the intervention'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lifestyle', 'description': 'Both active and control groups will receive counseling on nutrition and physical activity.\n\nLifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.'}, {'id': 'BG001', 'title': 'Prevention Intervention', 'description': 'Active group will receive 8 weeks of mindfulness based parenting stress intervention\n\nLifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.\n\nMindfulness Based Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '31.6', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '30.2', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '31', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age in years via self report', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race & Ethnicity', 'classes': [{'categories': [{'title': 'African American, Hispanic and Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2013-10-27', 'resultsFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-10', 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance', 'timeFrame': '8 weeks', 'description': 'Attendance rates (average number of sessions) were compared across groups.'}], 'secondaryOutcomes': [{'measure': 'Change in BMI Percentile', 'timeFrame': '8 weeks', 'description': 'A comparison between groups to determine the impact of the intervention on BMI percentile.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Parental Stress', 'Parent and Child Stress', 'Parental and Child Obesity', 'Child Obesity']}, 'referencesModule': {'references': [{'pmid': '30241766', 'type': 'RESULT', 'citation': 'Jastreboff AM, Chaplin TM, Finnie S, Savoye M, Stults-Kolehmainen M, Silverman WK, Sinha R. Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention: A Randomized Pilot Study. J Pediatr. 2018 Nov;202:136-142.e1. doi: 10.1016/j.jpeds.2018.07.011. Epub 2018 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.', 'detailedDescription': 'This project was a preliminary feasibility and pilot efficacy study to assess stressed low income parents of toddlers who were obese to assess whether a mindfulness based parenting intervention (PMH) can reduce their stress, increase parenting and improve family healthy food and physical activity choices. Parents and toddlers also participated in a Toy Wait Task, a behavioral assay of parenting.The empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling (Control) for parents of preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone condition to assess whether PMH improved toddler weight, physical activity and parent emotion regulation and healthy eating.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between ages 18-70 years;\n2. Able to read and write (parent)\n3. Family with a child between 2-5 years old\n4. BMI of parent in obese category\n5. High parenting stress (mean score of \\>=3 on 3 questions from Parenting Stress Index)\n\nExclusion Criteria:\n\n1. Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation\n2. Diagnosis of mental retardation, autism or other pervasive developmental disorder for child\n3. Inability to give informed consent\n4. Current serious medical disorder precluding participation in physical activity'}, 'identificationModule': {'nctId': 'NCT01974102', 'briefTitle': 'Family Based Mindfulness Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention', 'orgStudyIdInfo': {'id': '1306012264'}, 'secondaryIdInfos': [{'id': '5R21AT007708', 'link': 'https://reporter.nih.gov/quickSearch/5R21AT007708', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lifestyle', 'description': 'Attentional control group will receive weekly meeting to view relaxing video and facilitate discussion along with counseling on nutrition and physical activity for 8 weeks.', 'interventionNames': ['Behavioral: Lifestyle counseling']}, {'type': 'EXPERIMENTAL', 'label': 'therapy', 'description': 'Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.', 'interventionNames': ['Behavioral: Lifestyle counseling', 'Behavioral: Parenting Mindfully for Health (PMH)']}], 'interventions': [{'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'description': 'Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.', 'armGroupLabels': ['lifestyle', 'therapy']}, {'name': 'Parenting Mindfully for Health (PMH)', 'type': 'BEHAVIORAL', 'description': 'Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.', 'armGroupLabels': ['therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Stress Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Rajita Sinha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}