Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-25 @ 2:36 AM
Study NCT ID:
NCT00579605
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2007-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing to Promote Sustained Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003153', 'term': 'Community Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2007-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of any breastfeeding', 'timeFrame': 'From delivery to 6 months after birth', 'description': 'Number of days of any breastfeeding'}], 'secondaryOutcomes': [{'measure': 'Increased Breastfeeding self-efficacy', 'timeFrame': 'From birth to 6 months after delivery', 'description': 'Self-reported maternal satisfaction with breastfeeding'}, {'measure': 'Increased intention to breastfeed for 6 months', 'timeFrame': 'From birth to 6 months', 'description': 'Self-reported maternal intention to breastfeed for a 6 month period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breastfeeding', 'Self-efficacy', 'Motivational Interviewing'], 'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': '1. Evaluate the cultural appropriateness of an intervention protocol related to: a) motivational interviewing technique; b) stool, urine, and breast milk sample collection; and c) infant breastfeeding test weight procedure.\n2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.\n3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4) and evaluate fecal and breast milk samples of infants for human milk oligosaccharide levels.', 'detailedDescription': "The incidence of asthma, the most common serious chronic inflammatory disease among children, is rising each year. Therefore nursing interventions aimed at promoting infant immunity and mitigating factors to which the infant may be exposed may reduce the complications of this chronic illness. Breastfeeding is an ideal initial prevention strategy that strengthens the infant's immune system. In addition, the identification of biomarkers that reflect infant immune response sets the stage for the evaluation of nursing interventions targeted to decrease the impact of this chronic inflammatory disease. Although more mothers currently initiate breastfeeding, they do not sustain breastfeeding for the recommended 6 to 12 months. In general, Native American mothers' breastfeed for a shorter period of time and mothers in rural setting have fewer resources to support breastfeeding."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for mothers include ≥ 19 years of age and enrolled in Northern Plains Healthy Start program.\n* Inclusion criteria for infants are birth weight of \\> 2500 gms, \\> 37 weeks gestation, a bilirubin of 15 mg%, and no NICU admission to provide a sample of stable infants.\n\nExclusion Criteria:\n\n* Mothers who report that they will not breastfeed will be excluded.\n* Infants with a birth weight \\< 2500 gms, are \\< 37 weeks gestation, or diagnosed with any significant health problems, significant postnatal problems requiring NICU admission, symptoms of drug withdrawal, or a bilirubin \\> 15 mg% will be not be recruited for the study.'}, 'identificationModule': {'nctId': 'NCT00579605', 'briefTitle': 'Motivational Interviewing to Promote Sustained Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Motivational Interviewing to Promote Sustained Breastfeeding (Native American Women)', 'orgStudyIdInfo': {'id': '0273-06-FB'}, 'secondaryIdInfos': [{'id': 'UNMC MIHERO Internal Grant', 'type': 'OTHER_GRANT', 'domain': 'University of Nebraska Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Motivational Interviewing', 'description': '1 intervention group 1 attention intervention group Behavioral: Motivational Interviewing Client-centered strategy that may decrease ambivalence in behavior performance', 'interventionNames': ['Behavioral: Motivational Interviewing']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'otherNames': ['Counseling'], 'description': 'Client-centered strategy that may decrease ambivalence in behavior performance with attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.', 'armGroupLabels': ['1 Motivational Interviewing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susan M Wilhelm, RNC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska Medical Center, College of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}