Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT05473767
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2022-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-16', 'releaseDate': '2025-11-21'}, {'releaseDate': '2025-12-17'}], 'estimatedResultsFirstSubmitDate': '2025-11-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079262', 'term': 'Pregnancy in Obesity'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'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'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Investigators will be blind to group assignment during intervention delivery and assessment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial pilot study that will randomize 100 women into Family Check-Up Heart and 50 women into traditional Family Check-Up. The investigators will use an unbalanced design to enhance ability to evaluate feasibility and acceptability for the new Family Check-Up Heart intervention. The investigators will utilize a Type 1 hybrid effectiveness-implementation design using mixed methods that will simultaneously assess both the implementation of the Family Check-Up Heart and preliminary effectiveness on 6-month maternal cardiovascular health outcomes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postpartum weight retention', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Weight change from post-delivery to 6 months; both will be measured by the study using validated Bluetooth devices and following standardized research protocols.'}], 'secondaryOutcomes': [{'measure': 'Weight at 6 months postpartum', 'timeFrame': '6 months post-partum', 'description': 'Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols.'}, {'measure': 'Weight change from first measured prenatal weight to 6 months postpartum', 'timeFrame': 'Baseline to 6 months post-partum', 'description': "First measured prenatal weight will be obtained from the participant's medical record at baseline. Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols."}, {'measure': 'Change in self-reported pre-pregnancy weight to 6 months postpartum', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Pre-pregnancy weight will be self-reported at the baseline assessment. Weight at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols.'}, {'measure': 'Change in blood pressure from post-delivery to 6 months', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Blood pressure will be measured by the study at baseline and again at 6-months post-partum using validated Bluetooth devices and following standardized research protocols.'}, {'measure': 'Change in blood pressure from first prenatal visit to 6 months', 'timeFrame': 'Baseline to 6 months post-partum', 'description': "First measured prenatal blood pressure will be obtained from the participant's medical record at baseline. Blood pressure at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols."}, {'measure': 'Blood pressure at 6 months post-partum', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Blood pressure at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols.'}, {'measure': 'BMI at 6 months post-partum', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Height and Weight at 6 months post-partum will be assessed by the study using a validated Bluetooth scale and following standardized research protocols.'}, {'measure': 'Change in eating behaviors', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Eating behaviors will be assessed at baseline and 6 months post-partum using the Rapid Eating Assessment for Participants - Shortened Version. The Rapid Eating Assessment for Participants is a 16-item self-report scale assessing frequency of various eating behaviors such as skipping breakfast and eating fried foods. Items are rated on a 3-point response scale ranging from Usually/Often (1) to Rarely/Never (3). Three items also have a "Does not apply to me" option which is also coded as a 3. An example of an item with this option is "Eat more than 8 ounces of meat, chicken, turkey, or fish per day." The first 13 items are summed to create a score where higher values indicate healthier eating behaviors. Minimum and maximum scores are 13 and 39, respectively.'}, {'measure': 'Change in physical activity', 'timeFrame': 'Baseline to 6 months post-partum', 'description': 'Physical activity will be measured using the Pregnancy Physical Activity Questionnaire. The Pregnancy Physical Activity Questionnaire is a 26-item self-report of activities such as jogging or running, dancing, and watching television or a video. Items are rated on a 6-point likert-type scale ranging from Never to 3 or more hours per day. Responses are weighted to generate metabolic equivalent codes. Specifically, the self-reported time spent in each activity will be multiplied by its intensity to arrive at a measure of average weekly energy expenditure attributable to each activity. The metabolic equivalent codes are then summed to create a physical activity score where higher values indicate greater physical activity. Minimum and maximum scores are 0 and 308.85, respectively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular health', 'Postpartum women', 'Health Promotion'], 'conditions': ['Obesity, Maternal', 'Hypertension in Pregnancy', 'Hypertension, Pregnancy-Induced', 'Diabetes', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '15510530', 'type': 'BACKGROUND', 'citation': 'Segal-Isaacson CJ, Wylie-Rosett J, Gans KM. Validation of a short dietary assessment questionnaire: the Rapid Eating and Activity Assessment for Participants short version (REAP-S). Diabetes Educ. 2004 Sep-Oct;30(5):774, 776, 778 passim. doi: 10.1177/014572170403000512. No abstract available.'}, {'pmid': '15595297', 'type': 'BACKGROUND', 'citation': 'Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004 Oct;36(10):1750-60. doi: 10.1249/01.mss.0000142303.49306.0d.'}]}, 'descriptionModule': {'briefSummary': 'This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on postpartum mothers and infants. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.', 'detailedDescription': 'This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on pregnant and postpartum mothers. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.\n\nA second goal of the hybrid study is to understand the reach, engagement, and context for implementation of Family Check-Up Heart and gather information for development of the multi-center home visiting model trial. The Family Check-Up Heart program is intended to improve the cardiovascular health of low-income mothers compared to the traditional Family Check-Up and other home visiting programs by incorporating individualized, culturally competent interventions that target diet and exercise, blood pressure control, stress management and self-care, and smoking cessation. The intervention includes cardiovascular assessment and feedback, followed by a tailored treatment program delivered by family coaches in 3-4 week modules to establish goals and track progress. These sessions will work towards obtaining positive cardiovascular health outcomes and empowering mothers of infants to achieve their goals through education and a connection to resources which the investigators hypothesize will also preserve child cardiovascular health. Primary analyses will assess the impact of Family Check-Up Heart on maternal cardiovascular health outcomes when the child is 6 months old compared to Family Check-Up alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult inclusion criteria:\n\n 1. Pregnant women/birthing people or women/birthing people who have delivered in the past 2 months who deliver at Magee or are enrolled in the Women Infants and Children program in Allegheny County.\n 2. Medicaid-eligible\n 3. Speak English.\n 4. Resident of Allegheny County, Pennsylvania.\n 5. Does not have complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.\n\nParticipants who consent to enrollment may have their medical history reviewed by study physicians and staff to adjudicate pregnancy outcomes and ensure they meet inclusion criteria before randomization.\n\nChild inclusion criteria:\n\n1. Children birth through 2 months who reside in Allegheny County may enroll in the program if their mother is participating in the study.\n2. Has a legal guardian who speaks English. This criterion is included because the project's materials and assessments are currently only available in English, with staff only fluent in English.\n\nExclusion Criteria:\n\n1. Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.\n2. Multifetal pregnancies or deliveries."}, 'identificationModule': {'nctId': 'NCT05473767', 'briefTitle': 'Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)', 'orgStudyIdInfo': {'id': 'STUDY22020096'}, 'secondaryIdInfos': [{'id': '1UG3HL163116-01', 'link': 'https://reporter.nih.gov/quickSearch/1UG3HL163116-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Family Check Up Control', 'description': 'The Family Check-Up is a home visiting program that typically takes place over the course of 3-5 sessions - An initial interview, assessment, feedback session, and optional treatment sessions. The Family Check-Up is designed to support child development and improve parental well-being.', 'interventionNames': ['Behavioral: Family Check-Up']}, {'type': 'EXPERIMENTAL', 'label': 'Family Check-Up Heart', 'description': 'Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.', 'interventionNames': ['Behavioral: Family Check Up Heart']}], 'interventions': [{'name': 'Family Check Up Heart', 'type': 'BEHAVIORAL', 'description': 'Family Check-Up Heart consists of the Family Check up with an added heart health component. The Family Check-Up Heart assessment will include evaluations of maternal cardiovascular health; specifically, measurement of maternal blood pressure, body mass index, diet quality, exercise, and smoking, which will be included in the feedback session. After the Feedback Session participants will also receive information about healthy eating and weight loss, stress management, and smoking and to monitor weight and blood pressure.', 'armGroupLabels': ['Family Check-Up Heart']}, {'name': 'Family Check-Up', 'type': 'BEHAVIORAL', 'description': 'The Family Check-Up typically takes place over the course of 3-5 sessions, each about an hour long. First, a trained Family Check-Up family coach will conduct an "Initial Interview." Second is an assessment of that includes questionnaires and videotaped interaction tasks. Third, during the Feedback Session, the family coach discusses with the participant strengths and challenges for their child and family as a whole. They then set goals for their family to support and maintain strengths, and to address any areas of concern. After the Feedback Session families have the option to continue meeting with their family coach to support the child\'s development and improve parental well-being.', 'armGroupLabels': ['Family Check Up Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15208', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Healthy Start, Inc.', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15222', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Women, Infants, and Children Program', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Janet M Catov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPMC Magee Womens Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'We will share data within two years of the end of our funding to allow time for analysis and dissemination of findings.', 'ipdSharing': 'YES', 'description': 'Following the requirements of the University of Pittsburgh Institutional Review Board, investigators may access de-identified data following request and approval by the study Principle Investigators. All data will be shared, except when deemed protected health information. For example, maternal age at delivery will be shared by not date of birth or date of delivery (only year). The Principle Investigators will oversee data sharing to ensure no personally identifiable information is shared, and the study data manager has protocols to implement these processes.', 'accessCriteria': 'Interested investigators seek written approval from the study Principle Investigators. An Institutional Review Board protocol approved by their institution or a signed data sharing agreement is needed to access the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Janet Catov', 'investigatorAffiliation': 'University of Pittsburgh'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-21', 'type': 'RELEASE'}, {'date': '2025-12-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Janet Catov, Associate Professor, University of Pittsburgh'}}}}