Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01329835
Status:
UNKNOWN
Last Update Posted:
2011-12-06
First Post:
2011-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-05', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-04-04', 'lastUpdatePostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational weight gain', 'timeFrame': 'For the duration of pregnancy, an expected average of 40 weeks', 'description': 'Weight just before delivery minus prepregnancy weight'}], 'secondaryOutcomes': [{'measure': 'Evolutions in anxiety and depression during pregnancy', 'timeFrame': 'During pregnancy on fixed time points: trimester 1 (before 15 weeks of gestation), trimester 2 (between 18 and 28 weeks of gestation) and trimester 3 (between 30 - 34 weeks of gestation)', 'description': 'STAI (Spielberger) ==\\> anxiety EPDS ==\\> depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obese Pregnant Women']}, 'descriptionModule': {'briefSummary': "Prepregnancy obesity, defined as a body mass index (BMI) of 30kg/m² or more, shows a strong association with pregnancy and birth complications for both the mother and her child. Most consequently reported maternal risks include an increased risk for gestational diabetes, hypertension and pre-eclampsia, increased incidence of induction of labour, operative delivery, postpartum haemorrhage, anaesthetic risks as well as risk for infections and thromboembolic complications. Fetal risks include miscarriage, neural-tube defects, heart defects, macrosomia and stillbirth. Initiation and continuation of breastfeeding is more complicated in obese women than in normal weight women. Also in later life chronic diseases can put the mother and her baby's health at risk. The Institute Of Medicine (IOM) guidelines suggest a gestational weight gain (GWG) to be limited to 5 - 9 kg (11-19,8 lb) in obese women in order to minimize the synergetic negative health consequences of excessive weight gain for both the obese mother and her child. Preventing excessive weight gain during pregnancy and postpartum weight retention is also important in the prevention of overweight and obesity among women of reproductive age. Obese women in general have a poor diet quality and are more exposed to psychosocial factors like anxiety and feelings of depression than normal weight women.\n\nThe aim of this project is to perform a randomized controlled trial (RCT) in order to evaluate the effects of life-style intervention (psycho-education by a midwife during 4 prenatal sessions) on pregnancy and birth outcomes. Main dependent variables are gestational weight gain and anxiety and depression. Obesity is a modifiable risk factor and optimizing an adequate gestational weight gain with attention to psycho-social factors, can reduce the need for adverse perinatal outcomes."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than 15 weeks pregnant\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Preexisting diabetes\n* Primary need for nutritional advice\n* Inadequate knowledge of Dutch language'}, 'identificationModule': {'nctId': 'NCT01329835', 'briefTitle': 'Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Limburg Catholic University College'}, 'officialTitle': 'Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women', 'orgStudyIdInfo': {'id': 'GWG32011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Written information via brochure', 'description': 'Written information by a brochure', 'interventionNames': ['Other: brochure']}, {'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'standard prenatal care'}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'Psycho-education based on principles of motivational interviewing and positive reinforcement', 'interventionNames': ['Behavioral: Lifestyle counseling']}], 'interventions': [{'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'description': '4 prenatal sessions based on principles of motivational interviewing and positive reinforcement', 'armGroupLabels': ['Lifestyle counseling']}, {'name': 'brochure', 'type': 'OTHER', 'description': 'brochure given after randomization', 'armGroupLabels': ['Written information via brochure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Wilfried Gyselaers, PhD, MD', 'role': 'CONTACT', 'email': 'wilfried.gyselaers@zol.be'}, {'name': 'Annick Bogaerts, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St-Jans Hospital ZOL', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Fancoise Jadoul, MD', 'role': 'CONTACT', 'email': 'francoise.jadoul@jessa.be'}], 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '3550', 'city': 'Heusden', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Luc Buekenhout, MD', 'role': 'CONTACT', 'email': 'luc.buekenhout@sfz.be'}], 'facility': 'SFZ', 'geoPoint': {'lat': 51.03664, 'lon': 5.28013}}], 'overallOfficials': [{'name': 'Roland Devlieger, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Bea Van den Bergh, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tilburg (Nl)'}, {'name': 'Ingrid Witters, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Annick Bogaerts, MW, MSc, PhDstudent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KHLim PHL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Limburg Catholic University College', 'class': 'OTHER'}, 'collaborators': [{'name': 'PHL University College', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Wim Jackmaer', 'oldOrganization': 'PHL University College'}}}}