Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT01746394
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational weight gain', 'timeFrame': '9 months gestation', 'description': 'Percentages of gestational weight gain which fall within the ranges recommended by the Institute of Medicine (based on pre-pregnancy body mass index)'}, {'measure': 'Maternal postpartum weight retention', 'timeFrame': '12 months postnatal', 'description': 'Amount of weight retained at 12 months postpartum compared to self-reported pre-pregnancy weight'}, {'measure': 'Maternal dietary intake', 'timeFrame': '12 months postpartum', 'description': 'Dietary intake measured using 24-hour dietary recall'}, {'measure': 'Maternal physical activity', 'timeFrame': '12 months postpartum', 'description': 'Physical activity measured using a physical activity questionnaire'}, {'measure': 'Infant dietary intake', 'timeFrame': '12 months after birth', 'description': 'Dietary intake measured using 24-hour dietary recall as reported by mother'}, {'measure': 'Infant activity', 'timeFrame': '12 months after birth', 'description': 'Activity measured using responses to questions concerning time spent confined (e.g. in infant seat) and unconfined (e.g. on play mat)'}, {'measure': 'Infant body mass index', 'timeFrame': '12 months after birth', 'description': 'Incremental body mass index during the first year of life'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding', 'timeFrame': '12 months postpartum', 'description': 'Breastfeeding initiation and continuation for first 12 months after birth of infant'}, {'measure': 'Home food environment', 'timeFrame': '12 months postpartum', 'description': 'Measured using home food inventory; based on direct observation of foods in household (i.e. in refrigerator, freezer, pantry, cupboards, or other areas food is stored)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'pregnant women', 'nutrition assessment', 'health behavior'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24685997', 'type': 'BACKGROUND', 'citation': 'Thomson JL, Tussing-Humphreys LM, Goodman MH. Delta Healthy Sprouts: a randomized comparative effectiveness trial to promote maternal weight control and reduce childhood obesity in the Mississippi Delta. Contemp Clin Trials. 2014 May;38(1):82-91. doi: 10.1016/j.cct.2014.03.004. Epub 2014 Mar 29.'}, {'pmid': '29785275', 'type': 'DERIVED', 'citation': 'Thomson JL, Tussing-Humphreys LM, Goodman MH, Landry AS. Infant activity and sleep behaviors in a maternal and infant home visiting project among rural, southern, African American women. Matern Health Neonatol Perinatol. 2018 May 16;4:10. doi: 10.1186/s40748-018-0078-0. eCollection 2018.'}, {'pmid': '29396153', 'type': 'DERIVED', 'citation': 'Thomson JL, Tussing-Humphreys LM, Landry AS, Goodman MH. No Improvements in Postnatal Dietary Outcomes Were Observed in a Two-Arm, Randomized, Controlled, Comparative Impact Trial among Rural, Southern, African-American Women. J Acad Nutr Diet. 2018 Jul;118(7):1196-1207. doi: 10.1016/j.jand.2017.11.010. Epub 2018 Feb 1.'}, {'pmid': '29214042', 'type': 'DERIVED', 'citation': 'Tussing-Humphreys LM, Thomson JL, Hemphill NO, Goodman MH, Landry AS. Maternal weight in the postpartum: results from the Delta healthy sprouts trial. Matern Health Neonatol Perinatol. 2017 Dec 4;3:20. doi: 10.1186/s40748-017-0058-9. eCollection 2017.'}, {'pmid': '28405211', 'type': 'DERIVED', 'citation': 'Thomson JL, Tussing-Humphreys LM, Goodman MH, Landry AS, Olender SE. Low rate of initiation and short duration of breastfeeding in a maternal and infant home visiting project targeting rural, Southern, African American women. Int Breastfeed J. 2017 Apr 8;12:15. doi: 10.1186/s13006-017-0108-y. eCollection 2016.'}, {'pmid': '27779937', 'type': 'DERIVED', 'citation': 'Thomson JL, Tussing-Humphreys LM, Goodman MH, Olender SE. Physical Activity Changes during Pregnancy in a Comparative Impact Trial. Am J Health Behav. 2016 Nov;40(6):685-696. doi: 10.5993/AJHB.40.6.1.'}, {'pmid': '27595023', 'type': 'DERIVED', 'citation': 'Thomson JL, Tussing-Humphreys LM, Goodman MH, Olender SE. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial. J Pregnancy. 2016;2016:5703607. doi: 10.1155/2016/5703607. Epub 2016 Aug 9.'}, {'pmid': '27536380', 'type': 'DERIVED', 'citation': 'Tussing-Humphreys LM, Thomson JL, Goodman MH, Olender S. Maternal diet quality and nutrient intake in the gestational period: results from the delta healthy sprouts comparative impact trial. Matern Health Neonatol Perinatol. 2016 Aug 17;2:8. doi: 10.1186/s40748-016-0036-7. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150 African American women in their early second trimester of pregnancy. The control arm, Parents as Teachers, is an evidence-based approach to increase parental knowledge of child development and improve parenting practices. The experimental arm, Parents as Teachers Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical activity components specifically designed for the gestational and postnatal periods. Both arms of the intervention will be implemented by community-based, trained Parent Educators. The comparative effectiveness of the two intervention arms on weight status, dietary intake, and health behaviors of mothers and their infants will be assessed. The Delta Healthy Sprouts Project will determine if a novel, scalable, lifestyle intervention can improve the health of African American women and their children at high-risk for obesity and chronic disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Less than 18 weeks pregnant with first, second, or third child\n* Resident of Mississippi counties of Washington and Bolivar\n\nExclusion Criteria:\n\n* Pregnant with more than one fetus'}, 'identificationModule': {'nctId': 'NCT01746394', 'briefTitle': 'Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta', 'organization': {'class': 'FED', 'fullName': 'USDA, Delta Human Nutrition Research Program'}, 'officialTitle': 'Delta Healthy Sprouts: A Randomized Trial to Determine the Comparative Efficacy of Two Maternal, Infant, and Early Childhood Home Visiting Programs on Maternal Weight Control and Childhood Obesity in the Mississippi Delta', 'orgStudyIdInfo': {'id': 'DHN_12_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parents as Teachers Enhanced', 'description': 'Participants in the Parents as Teachers Enhanced (PaTE) intervention arm will receive the enhanced diet and activity maternal, infant, and early childhood home visiting program', 'interventionNames': ['Behavioral: Parents as Teachers Enhanced', 'Behavioral: Parents as Teachers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parents as Teachers', 'description': 'Participants in the Parents as Teachers (PaT) control arm will receive the standard maternal, infant, and early childhood home visiting program', 'interventionNames': ['Behavioral: Parents as Teachers']}], 'interventions': [{'name': 'Parents as Teachers Enhanced', 'type': 'BEHAVIORAL', 'otherNames': ['PaTE'], 'description': 'Participants will receive the same monthly Parents as Teachers (PaT) lessons and materials at each home visit as the PaT arm. Additionally, these mothers will receive the enhanced nutrition and physical activity lessons and materials which will follow the family well-being format of the PaT lessons. The StartSmart lessons will focus on healthy gestational weight gain, diet, physical activity, breastfeeding, weight management, healthy eating, food shopping, meal preparation, physical activity, proper infant feeding, and infant activity time.', 'armGroupLabels': ['Parents as Teachers Enhanced']}, {'name': 'Parents as Teachers', 'type': 'BEHAVIORAL', 'otherNames': ['PaT'], 'description': "Participants will receive monthly Parents as Teachers (PaT) lessons and materials at each home visit. The Parent Educator will first connect with the mother by discussing or reviewing content from the prior visit; reflect on the mother's experience with continuing the parent-child activity from the prior visit; and agree on what will happen during the current visit. For the lesson plan, the Parent Educator will cover the following three areas using discussion, activities, and handouts: parent-child interaction, develop-centered parenting, and family well-being. In closing, the Parent Educator will review and evaluate the visit, talk about the mother's next step, and plan for the next visit.", 'armGroupLabels': ['Parents as Teachers', 'Parents as Teachers Enhanced']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38776', 'city': 'Stoneville', 'state': 'Mississippi', 'country': 'United States', 'facility': 'USDA Agricultural Research Service Mid South Area Office', 'geoPoint': {'lat': 33.42401, 'lon': -90.9151}}], 'overallOfficials': [{'name': 'Jessica L Thomson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Agricultural Research Service'}, {'name': 'Lisa M Tussing-Humphreys, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Delta Human Nutrition Research Program', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}