Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05446220
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2022-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000078064', 'term': 'Gestational Weight Gain'}], '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'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 497}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '2 years data collection', 'description': 'Fatt mass index offspring, DXA scan + BMI mothers'}], 'secondaryOutcomes': [{'measure': 'Metabolic and inflammatory markers', 'timeFrame': '2 years data collection', 'description': 'Analyses of blood samples'}, {'measure': 'Blood pressure', 'timeFrame': '2 years data collection', 'description': 'Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures'}, {'measure': 'Glycemic variability', 'timeFrame': '2 years data collection', 'description': 'CGM measures'}, {'measure': 'Mental health', 'timeFrame': '2 years data collection', 'description': 'Assessed by questionnaires, validated to mother and child respectively'}, {'measure': 'Diet composition', 'timeFrame': '2 years data collection', 'description': 'Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively'}, {'measure': 'Level and pattern of physical activity', 'timeFrame': '2 years data collection', 'description': 'Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire)'}, {'measure': 'Relative fitness level', 'timeFrame': '2 years data collection', 'description': 'Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test)'}, {'measure': 'Epigenetic examinations', 'timeFrame': '2 years data collection', 'description': 'Epigenetic examinations'}, {'measure': 'Liver stiffness', 'timeFrame': '2 years data collection', 'description': 'FibroScan'}, {'measure': 'Lung function', 'timeFrame': '2 years data collection', 'description': 'Spirometry assessing FVC and FEV1'}, {'measure': 'Large artery stiffness', 'timeFrame': '2 years data collection', 'description': 'SphygmoCor examination'}, {'measure': 'Eye examination', 'timeFrame': '2 years data collection', 'description': 'OPTOS'}, {'measure': 'Sex hormones', 'timeFrame': '2 years data collection', 'description': 'Analyses of blood samples, children'}, {'measure': 'Puberty stage', 'timeFrame': '2 years data collection', 'description': 'According to the classifications of Marshall and Tanner'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Lifestyle, Healthy', 'Diet, Healthy', 'Follow-up', 'Physical Activity', 'Body Composition', 'Gestational Weight Gain']}, 'descriptionModule': {'briefSummary': 'The participant (both mother and child) in the initial TOP study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. The study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.', 'detailedDescription': 'The initial study (Treatment of Obese Pregnant women (TOP) study) was performed at Hvidovre Hospital, University of Copenhagen in 2009-12 and included 425 pregnant women with pre-gestational BMI ≥ 30kg/m2 in gestational week 11-14. They were randomized 1:1:1 into: 1) a low-calorie Mediterranean-style diet and pedometer assisted physical activity (PA) intervention 2) a pedometer assisted PA intervention alone or 3) no intervention (control). Primary outcome was gestational weight gain (GWG). 389 women completed the study.\n\nThe participants (both mother and child in pair) who completed the initial TOP study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants/mothers in the initial TOP study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study\n\nExclusion Criteria:\n\n* There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012'}, 'identificationModule': {'nctId': 'NCT05446220', 'acronym': 'TOP12', 'briefTitle': 'Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study', 'orgStudyIdInfo': {'id': 'TOP12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet + physical activity', 'description': 'Dietary advise and advise on physical activity monitored by pedometer', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Physical activity', 'description': 'Advise on physical activity monitored by pedometer', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Dietary advise and/or advise on physical activity monitored by pedometer', 'armGroupLabels': ['Diet + physical activity', 'Physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Kristina M Renault', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Statens Serum Institut', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}