Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-22 @ 9:56 AM
Study NCT ID:
NCT02520167
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational weight gain', 'timeFrame': '40 weeks', 'description': 'Weight change from pre-pregnancy to time of delivery'}], 'secondaryOutcomes': [{'measure': 'Maternal fruit intake', 'timeFrame': 'Assessed from 12 weeks gestation through 6 weeks postpartum', 'description': 'Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum'}, {'measure': 'Maternal vegetable intake', 'timeFrame': 'Assessed from 12 weeks gestation through 6 weeks postpartum', 'description': 'Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum'}, {'measure': 'Maternal whole grains intake', 'timeFrame': 'Assessed from 12 weeks gestation through 6 weeks postpartum', 'description': 'Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum'}, {'measure': 'Maternal solid fats intake', 'timeFrame': 'Assessed from 12 weeks gestation through 6 weeks postpartum', 'description': 'Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum'}, {'measure': 'Maternal added sugars intake', 'timeFrame': 'Assessed from 12 weeks gestation through 6 weeks postpartum', 'description': 'Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum'}, {'measure': 'Maternal physical activity', 'timeFrame': 'Assessed from 12 weeks gestation through 6 weeks postpartum', 'description': 'Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum'}, {'measure': 'Exclusive breastfeeding', 'timeFrame': 'Assessed at 6 weeks postpartum', 'description': 'Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gestational weight gain'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the Diabetes Prevention Program (DPP). Intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a DPP-based curriculum and receive breastfeeding education. Control group participants will receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.', 'detailedDescription': "This study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. The intervention is based on the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. Further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. The investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies of \\<12 weeks gestation\n* Pre-pregnant body mass index \\>=30\n* Speak and understand English\n* Plan to continue care at the clinic through pregnancy and postpartum\n\nExclusion Criteria:\n\n* Pre-existing diabetes\n* History of serious chronic illnesses\n* History of prior gestational diabetes\n* Prior delivery at \\<37 weeks gestation\n* Prior delivery of infant weighing \\<2500g'}, 'identificationModule': {'nctId': 'NCT02520167', 'briefTitle': 'Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study', 'orgStudyIdInfo': {'id': '15-0760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary and Lifestyle Counseling', 'description': 'Women randomized to the intervention group will meet with a dietary counselor for 15 minutes at every prenatal appointment. They will receive a dietary and lifestyle curriculum based on the Diabetes Prevention Program curriculum (11 lessons) with one additional lesson providing prenatal breastfeeding education. They will also have access to a private online Facebook page for additional education and peer group support.', 'interventionNames': ['Behavioral: Dietary and Lifestyle Counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Usual prenatal care consists of regular clinical appointments, pregnancy ultrasounds, and recommendations to use prenatal multivitamins, eat a balanced diet, and remain physically active. Women with a pre-pregnant body mass index \\> 30 complete early glucose screening (as early as possible after presentation at the clinic) to detect pre-existing diabetes, and all women undergo routine gestational diabetes screening at 24-28 weeks. Women who test positive for pre-existing diabetes or gestational diabetes are referred to a registered dietitian.'}], 'interventions': [{'name': 'Dietary and Lifestyle Counseling', 'type': 'BEHAVIORAL', 'description': 'Dietary and lifestyle education; Peer group support.', 'armGroupLabels': ['Dietary and Lifestyle Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Eastside Family Health Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Katherine A Sauder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available for this small pilot and feasibility study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}