Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:23 AM
Study NCT ID:
NCT07435857
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise During Pregnancy on the Long-term Metabolic Health of Mothers and Their Offspring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Mothers and their offspring, after an 8-14 hour fast, underwent blood sample collection. Maternal assessments included a 75-g OGTT with blood sampling at 120 minutes. Plasma glucose and insulin were measured via hexokinase and electrochemiluminescence methods, respectively. Insulin resistance was calculated using the HOMA equation. Fasting lipid profiles (total cholesterol, triglycerides, HDL-C, LDL-C) were also measured.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OGTT', 'timeFrame': '8-10 years', 'description': '75-g oral glucose tolerance test （0h，2h，mmol/L）'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '8-10 years', 'description': 'weight in kilograms, height in meters, and weight and height will be combined to report BMI in kg/m2'}, {'measure': 'anthropometric measures', 'timeFrame': '8-10 years', 'description': 'anthropometric measurements include waist circumference and skinfold thickness (centimeters) using skinfold caliper. Additionally，And use a body composition analyzer to measure body fat content and distribution （ The fat mass \\[kg\\]； fat percentage \\[%\\]； visceral fat area \\[cm2\\]； and lean mass \\[kg\\] were determined using bioimpedance analysis）.'}, {'measure': 'insulin resistance', 'timeFrame': '8-10 years', 'description': 'plasma insulin levels were measured using electrochemiluminescence, and insulin resistance was calculated via the HOMA equation (fasting plasma insulin concentration (μIU/mL) × fasting glucose concentration (mmol/L)/22.5).'}, {'measure': 'lipid profile', 'timeFrame': '8-10 years', 'description': 'fasting lipid profiles, including total cholesterol (TCHO), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were measured via the cholesterol oxidase method (mmol/L)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Obesity', 'Follow-up', 'Metabolism', 'Maternal-offspring'], 'conditions': ['Metabolic Health']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the long-term metabolic effects of gestational exercise on overweight and obese women and their offspring 8-10 years post-intervention.', 'detailedDescription': 'We conducted a follow-up study of a randomized controlled trial (RCT) in which the impact of prenatal exercise on the incidence of gestational diabetes mellitus (GDM) was investigated. Mother-offspring pairs underwent comprehensive metabolic evaluations, including anthropometric measurements (weight, skinfold thickness, and body composition), blood pressure assessment, oral glucose tolerance tests (OGTTs), insulin release tests (IRTs), and lipid profiling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This follow-up of a randomized trial included 300 overweight/obese pregnant women (prepregnancy BMI ≥24, \\<12⁺⁶ weeks gestation) from Peking University First Hospital (Dec 2014-Apr 2017). They were randomized to an exercise group (n=150, cycling three times/week, ≥30 min/session) or control group (n=150, usual activities). After excluding those who missed the OGTT (18 exercise, 17 control), 132 and 133 mother-offspring pairs, respectively, were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 132 mothers in the exercise group and 133 mothers in the control group in the previous RCT trial who had OGTT results and their offsprings were eligible for follow-up\n\nExclusion Criteria:\n\n\\- The criteria for exclusion from the follow-up study included loss to follow-up, refusal to participate, or major illness (acute lymphoblastic leukemia) of the mother or the child.'}, 'identificationModule': {'nctId': 'NCT07435857', 'briefTitle': 'Effects of Exercise During Pregnancy on the Long-term Metabolic Health of Mothers and Their Offspring', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Long-Term Effects of Exercise During Pregnancy on the Metabolic Health of Mothers and Their Offspring: An 8- to 10-year Follow-Up Study', 'orgStudyIdInfo': {'id': '2021YFC2700700'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'exercise group', 'description': 'We conduct a follow-up study of a randomized controlled trial (RCT) in which the impact of prenatal exercise on the incidence of gestational diabetes mellitus (GDM) was investigated. Mother-offspring pairs underwent follow up', 'interventionNames': ['Behavioral: exercise']}, {'label': 'control group', 'description': 'We conduct a follow-up study of a randomized controlled trial (RCT) in which the impact of prenatal exercise on the incidence of gestational diabetes mellitus (GDM) was investigated. Mother-offspring pairs underwent follow up'}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'The present study is a prospective follow-up of a randomized controlled trial (RCT) that was conducted in the Department of Obstetrics and Gynecology, Peking University First Hospital, from December 2014 to April 2017. In this RCT, 300 obese/overweight pregnant women (prepregnancy BMI ≥24 kg/m²) at \\<12+6 weeks of gestation were randomized to exercise (n=150) and control groups (n=150), and the efficacy of regular exercise in early pregnancy to prevent GDM among overweight/obese pregnant Chinese women was investigated. The patients allocated to the exercise group were assigned to a cycling program (3 times per week, at least 30 min/session, rating of perceived exertion 12-14); the program was initiated within 3 days of randomization and continued until 37 weeks of gestation. The patients in the control group maintained their usual daily activities. The original RCT has been reported previously （Wang, C.Am. J. Obstet. Gynecol. 2017, 216 (4), 340-351.)', 'armGroupLabels': ['exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Chen Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Frist hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Wang Chen', 'investigatorAffiliation': 'Peking University First Hospital'}}}}