Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00877994
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2009-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurture: A Program for Mothers With Histories of Disordered Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}], 'ancestors': [{'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parenting self-efficacy', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Disordered Eating', 'Parenting', 'Mothers'], 'conditions': ['Eating Disorders']}, 'descriptionModule': {'briefSummary': 'Nurture is a collaborative pilot study for mothers of children under the age of 3 who have suffered from disordered eating in the past. It is coordinated by the University of North Carolina at Chapel Hill, Duke University and Virginia Commonwealth University and sponsored by the National Institute of Mental Health. Nurture hopes to promote confident parenting and a positive meal times.', 'detailedDescription': 'Mothers who have struggled with disordered eating or body image struggles are often concerned how best to provide proper nutrition to their child and/or model healthy eating behavior. We have developed a curriculum that provides information about how to establish healthy eating patterns and social support for mothers with children under three years of age. The curriculum will be delivered in a support group format led by co-therapists affiliated with the UNC Eating Disorder Program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has met lifetime DSM-IV criteria for anorexia nervosa (AN), bulimia nervosa (BN), or eating disorder not otherwise specified (EDNOS: including subthreshold AN, BN, and purging disorder, but excluding BED)\n* BMI \\> 18.5 maintained for at least three months\n* Has not met threshold criteria for AN or BN in the previous 28 days according to the Eating Disorders Examination, although subthreshold status or active residual symptomatology will not preclude entry\n* Age 18 or older\n* Has a child between the ages of 1 month and 2 years, 12 months old\n\nExclusion Criteria:\n\n* Alcohol or drug dependence in the past year\n* Current significant suicidal ideation reported during the assessment or on the BDI-II at baseline\n* Developmental disability that would impair the ability of the participant to benefit from the intervention\n* Psychosis, including schizophrenia, or bipolar I disorder\n* Any families who have been the subject of social service inquiries'}, 'identificationModule': {'nctId': 'NCT00877994', 'briefTitle': 'Nurture: A Program for Mothers With Histories of Disordered Eating', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Breaking the Cycle of Risk: Intervention for Mothers With Eating Disorders', 'orgStudyIdInfo': {'id': '08-0236'}, 'secondaryIdInfos': [{'id': 'R34MH080750', 'link': 'https://reporter.nih.gov/quickSearch/R34MH080750', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate', 'description': 'This group will receive the nurture group therapy immediately after enrolling in the study.', 'interventionNames': ['Behavioral: Nurture Support Group Therapy', 'Behavioral: Group therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed', 'description': 'This group will receive the nurture group therapy 16 weeks after enrolling in the study.', 'interventionNames': ['Behavioral: Nurture Support Group Therapy', 'Behavioral: Group therapy']}], 'interventions': [{'name': 'Nurture Support Group Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Parenting group'], 'description': 'Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists.', 'armGroupLabels': ['Delayed', 'Immediate']}, {'name': 'Group therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Parenting groups'], 'description': 'Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. The curriculum will focus on increasing positive healthy eating patterns in children of mothers who have had disordered eating and body image struggles.', 'armGroupLabels': ['Delayed', 'Immediate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Cynthia Bulik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Nancy Zucker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Suzanne Mazzeo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}