Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-28 @ 9:26 PM
Study NCT ID:
NCT01541761
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2012-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Starting Early Obesity Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2012-02-24', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the prevalence and degree of obesity at age 3 years', 'timeFrame': '3 years', 'description': 'Continuous and dichotomized measures (BMI percentiles)'}, {'measure': 'Improvement in infant diet composition', 'timeFrame': '1-3 years', 'description': 'Diets of intervention group infants and children will be more likely to follow recommended guidelines including:\n\ni) Increased breastfeeding rates and duration ii) Appropriate timing of introduction to solids iii) Appropriate timing of bottle weaning iv) Increased fruit and vegetable consumption v) Decreased fast and junk food consumption vi) Decreased sugary beverage consumption vii) Age-appropriate portion sizes'}, {'measure': 'Improvement in infant lifestyle behaviors associated with increased risk of obesity.', 'timeFrame': '1-3 years', 'description': 'Measures of lifestyle behaviors among infants and children receiving intervention will be more likely to follow recommended guidelines than those of the control group including:\n\ni) Better sleep habits ii) Reduced screen time iii) Increased physical activity'}, {'measure': 'Improvement in parent feeding knowledge, attitudes, styles and practices', 'timeFrame': '1-3 years', 'description': 'Parent feeding knowledge, attitudes, styles and practices in the intervention group will be healthier than those of the control group including:\n\ni) Awareness of healthy child weight ii) Improved knowledge of optimal feeding practices iii) More responsive feeding style'}, {'measure': 'Reduction in infant and child excess weight gain', 'timeFrame': '1-3 years', 'description': 'Continuous anthropometric measures (weight for length z-scores)'}, {'measure': 'Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention', 'timeFrame': '2-5 years', 'description': 'Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors'}, {'measure': 'Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention', 'timeFrame': '2-5 years', 'description': 'Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain'}, {'measure': 'Feasibility process measures:', 'timeFrame': '2-5 years', 'description': 'Study population eligibility and enrollment, Proportion of pregnant women approached who meet eligibility criteria, Proportion of women meeting eligibility criteria who enroll These proportions will be calculated using study recruitment records.'}, {'measure': 'Participant engagement', 'timeFrame': '2-5 years', 'description': 'Proportion of enrolled mother-infant dyads that participate in the different aspects of the program. This will include the number of individual sessions with healthy steps, the number of individual sessions with the health educator, the number and type of referrals to community resources provided, and the number of Nutrition and Parenting Support Groups attended. This will enable us to determine the length of engagement in the program, proportion of enrolled mother-infant dyads that complete each study measure'}, {'measure': 'Participant satisfaction', 'timeFrame': '2-5 years', 'description': 'We will assess program satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Child', 'Hispanic', 'Prevention', 'Nutrition', 'Parenting'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '38301173', 'type': 'DERIVED', 'citation': 'Duh-Leong C, Messito MJ, Katzow MW, Kim CN, Mendelsohn AL, Scott MA, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention: Effects of Adverse Social Determinants of Health on Intervention Attendance and Impact. Child Obes. 2024 Oct;20(7):476-484. doi: 10.1089/chi.2023.0149. Epub 2024 Feb 1.'}, {'pmid': '36255444', 'type': 'DERIVED', 'citation': 'Vandyousefi S, Messito MJ, Scott MA, Gross RS. Do Appetite Traits Mediate the Link Between Birth Weight and Later Child Weight in Low-Income Hispanic Families? Child Obes. 2023 Oct;19(7):489-497. doi: 10.1089/chi.2022.0124. Epub 2022 Oct 17.'}, {'pmid': '36112108', 'type': 'DERIVED', 'citation': 'Katzow MW, Messito MJ, Mendelsohn AL, Scott MA, Gross RS. Protective Effect of Prenatal Social Support on the Intergenerational Transmission of Obesity in Low-Income Hispanic Families. Child Obes. 2023 Sep;19(6):382-390. doi: 10.1089/chi.2021.0306. Epub 2022 Sep 15.'}, {'pmid': '32883807', 'type': 'DERIVED', 'citation': 'Messito MJ, Mendelsohn AL, Katzow MW, Scott MA, Vandyousefi S, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial. Pediatrics. 2020 Oct;146(4):e20200709. doi: 10.1542/peds.2020-0709. Epub 2020 Sep 3.'}, {'pmid': '28332324', 'type': 'DERIVED', 'citation': 'Gross RS, Mendelsohn AL, Yin HS, Tomopoulos S, Gross MB, Scheinmann R, Messito MJ. Randomized controlled trial of an early child obesity prevention intervention: Impacts on infant tummy time. Obesity (Silver Spring). 2017 May;25(5):920-927. doi: 10.1002/oby.21779. Epub 2017 Mar 22.'}, {'pmid': '27113376', 'type': 'DERIVED', 'citation': 'Gross RS, Mendelsohn AL, Gross MB, Scheinmann R, Messito MJ. Randomized Controlled Trial of a Primary Care-Based Child Obesity Prevention Intervention on Infant Feeding Practices. J Pediatr. 2016 Jul;174:171-177.e2. doi: 10.1016/j.jpeds.2016.03.060. Epub 2016 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child\'s primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.\n\nThe proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.\n\nHypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices', 'detailedDescription': 'Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet.\n\nOur secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts. The new components of the expanded Starting Early Program will be feasible: Families will participate in the preschool intervention, and pregnant women will enroll in the prenatal intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Latina mother \\> 18 years with singleton uncomplicated pregnancy\n* Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services\n* Mother to be primary caregiver of child\n* Mother speaks fluent English or Spanish\n\nExclusion Criteria:\n\n* Maternal history of serious medical or psychiatric illness or drug or alcohol abuse\n* Family does not have a phone\n* Infants with severe medical problems that may affect feeding'}, 'identificationModule': {'nctId': 'NCT01541761', 'briefTitle': 'Starting Early Obesity Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'RCT Testing the Effectiveness of an Early Obesity Prevention Program', 'orgStudyIdInfo': {'id': '10-02175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family groups', 'description': 'Intervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic.', 'interventionNames': ['Behavioral: Family groups']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.'}], 'interventions': [{'name': 'Family groups', 'type': 'BEHAVIORAL', 'description': 'The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting.', 'armGroupLabels': ['Family groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hospital Center Ambulatory Care Clinic', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mary Jo Messito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}, {'name': 'Rachel Gross, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital at Montefiore"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Agriculture (USDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}