Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT02260518
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2014-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Health in Pregnancy and Postpartum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-efficacy for diet and physical activity', 'timeFrame': '32 weeks gestation', 'description': 'Self-report measure'}, {'measure': 'Self-efficacy for diet and physical activity', 'timeFrame': '6 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Self-efficacy for diet and physical activity', 'timeFrame': '12 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Social support for diet and physical activity', 'timeFrame': '32 weeks gestation', 'description': 'Self-report measure'}, {'measure': 'Social support for diet and physical activity', 'timeFrame': '6 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Social support for diet and physical activity', 'timeFrame': '12 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Decisional balance for diet and physical activity', 'timeFrame': '32 weeks gestation', 'description': 'Self-report measure'}, {'measure': 'Decisional balance for diet and physical activity', 'timeFrame': '6 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Decisional balance for diet and physical activity', 'timeFrame': '12 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Self-regulation for diet and physical activity', 'timeFrame': '32 weeks gestation', 'description': 'Self-report measure'}, {'measure': 'Self-regulation for diet and physical activity', 'timeFrame': '6 months postpartum', 'description': 'Self-report measure'}, {'measure': 'Self-regulation for diet and physical activity', 'timeFrame': '12 months postpartum', 'description': 'Self-report measure'}], 'primaryOutcomes': [{'measure': 'Gestational weight gain in pounds', 'timeFrame': 'Delivery', 'description': 'Defined as delivery room weight minus pre-pregnancy weight'}], 'secondaryOutcomes': [{'measure': 'Gestational weight gain category', 'timeFrame': 'Delivery', 'description': 'Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive'}, {'measure': 'Postpartum weight retention', 'timeFrame': 'Weight retained at the 6 month postpartum visit', 'description': 'Defined as weight during 6 month postpartum visit minus pre-pregnancy weight'}, {'measure': 'Postpartum weight retention', 'timeFrame': 'Weight retained at the 12 month postpartum visit', 'description': 'Defined as weight during 12 month postpartum visit minus pre-pregnancy weight'}, {'measure': 'Physical Activity', 'timeFrame': '32 weeks gestation', 'description': 'Sense Wear Armband and self-report measure will assess physical activity'}, {'measure': 'Physical Activity', 'timeFrame': '6 months postpartum', 'description': 'Sense Wear Armband and self-report measure will assess physical activity'}, {'measure': 'Physical Activity', 'timeFrame': '12 months postpartum', 'description': 'Sense Wear Armband and self-report measure will assess physical activity'}, {'measure': 'Dietary intake', 'timeFrame': '32 weeks gestation', 'description': "Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake."}, {'measure': 'Dietary intake', 'timeFrame': '6 months postpartum', 'description': "Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake."}, {'measure': 'Dietary intake', 'timeFrame': '12 months postpartum', 'description': "Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake."}, {'measure': 'Depressive Symptoms', 'timeFrame': '32 weeks gestation', 'description': 'Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.'}, {'measure': 'Depressive Symptoms', 'timeFrame': '6 months postpartum', 'description': 'Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.'}, {'measure': 'Depressive Symptoms', 'timeFrame': '12 months postpartum', 'description': 'Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '32 weeks gestation', 'description': 'The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months postpartum', 'description': 'The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '12 months postpartum', 'description': 'The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.'}, {'measure': 'Child Adiposity', 'timeFrame': '6 months postpartum', 'description': 'Z-scores and skinfolds will be used to measure child adiposity.'}, {'measure': 'Child Adiposity', 'timeFrame': '12 months postpartum', 'description': 'Z-scores and skinfolds will be used to measure child adiposity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gestational weight gain', 'Lifestyle intervention', 'Pregnancy', 'Postpartum', 'Physical activity', 'Nutrition'], 'conditions': ['Obesity', 'Pregnancy', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '39627794', 'type': 'DERIVED', 'citation': 'Wilcox S, Liu J, Sevoyan M, Parker-Brown J, Turner-McGrievy GM. Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in postpartum women with elevated weight: results of the HIPP randomized controlled trial. BMC Pregnancy Childbirth. 2024 Dec 3;24(1):808. doi: 10.1186/s12884-024-07007-8.'}, {'pmid': '36494702', 'type': 'DERIVED', 'citation': 'Wilcox S, Liu J, Turner-McGrievy GM, Boutte AK, Wingard E. Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in pregnant women with elevated weight: results of the HIPP randomized controlled trial. Int J Behav Nutr Phys Act. 2022 Dec 9;19(1):145. doi: 10.1186/s12966-022-01387-w.'}, {'pmid': '36289464', 'type': 'DERIVED', 'citation': 'Wilcox S, Dahl AA, Boutte AK, Liu J, Day K, Turner-McGrievy G, Wingard E. Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial. BMC Pregnancy Childbirth. 2022 Oct 26;22(1):794. doi: 10.1186/s12884-022-05107-x.'}, {'pmid': '36173829', 'type': 'DERIVED', 'citation': 'Wirth MD, Liu J, Wallace MK, McLain AC, Turner-McGrievy GM, Davis JE, Ryan N, Hebert JR. Dietary Inflammatory Index and sleep quality and duration among pregnant women with overweight or obesity. Sleep. 2022 Dec 12;45(12):zsac241. doi: 10.1093/sleep/zsac241.'}, {'pmid': '35722816', 'type': 'DERIVED', 'citation': 'Liu J, Wilcox S, Hutto B, Turner-McGrievy G, Wingard E. Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight. Obesity (Silver Spring). 2022 Jul;30(7):1370-1379. doi: 10.1002/oby.23449. Epub 2022 Jun 20.'}, {'pmid': '33786522', 'type': 'DERIVED', 'citation': 'Liu J, Wilcox S, Wingard E, Burgis J, Schneider L, Dahl A. Strategies and Challenges in Recruiting Pregnant Women with Elevated Body Mass Index for a Behavioral Lifestyle Intervention. Womens Health Rep (New Rochelle). 2020 Dec 7;1(1):556-565. doi: 10.1089/whr.2020.0089. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the impact of a lifestyle intervention on gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care control group.', 'detailedDescription': 'Our study will address the following specific aims: (1) examine the impact of a lifestyle intervention on gestational weight gain and postpartum weight loss in overweight and obese women, (2) examine the impact of the intervention on physical activity (PA), dietary intake, and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA, dietary intake, and QOL; and (4) examine the impact of the intervention on offspring adiposity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* White or African American woman\n* Overweight or obese (prepregnancy BMI: 25-45 kg/m2)\n* ≤ 16 wks gestation at screening\n* Age 18-44 years\n* No plan to move out of the greater Columbia area in next 18 months\n* Regular and consistent telephone access\n* Availability for telephone calls\n* Willing to accept random assignment\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Fetal anomaly\n* Taking insulin for diabetes\n* Uncontrolled or untreated thyroid disease\n* Mental health or substance-abuse hospitalization in last 6 months\n* Multiple gestation\n* Persistent bleeding in the first trimester\n* History of more than 3 miscarriages\n* History of an eating disorder or current eating disorder\n* History of an incompetent cervix\n* Physical disability that prevents exercise\n* Told by health care provider not to exercise\n* Any other medical conditions that might be a contraindication to exercise or dietary change'}, 'identificationModule': {'nctId': 'NCT02260518', 'acronym': 'HIPP', 'briefTitle': 'Promoting Health in Pregnancy and Postpartum', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women', 'orgStudyIdInfo': {'id': 'R01HD078407', 'link': 'https://reporter.nih.gov/quickSearch/R01HD078407', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HD078407', 'link': 'https://reporter.nih.gov/quickSearch/R01HD078407', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Intervention', 'description': 'The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines.', 'interventionNames': ['Behavioral: Lifestyle Intervention']}, {'type': 'OTHER', 'label': 'Standard Care', 'description': 'Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts.', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.', 'armGroupLabels': ['Lifestyle Intervention']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina Prevention Research Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Sara Wilcox, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}, {'name': 'Jihong Liu, Sc.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sara Wilcox', 'investigatorAffiliation': 'University of South Carolina'}}}}