Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT01039051
Status:
UNKNOWN
Last Update Posted:
2009-12-24
First Post:
2009-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diet and Lifestyle Intervention Study in Postpartum Women in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011645', 'term': 'Puerperal Infection'}, {'id': 'D005334', 'term': 'Fever'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D006484', 'term': 'Hemorrhoids'}, {'id': 'D005401', 'term': 'Fissure in Ano'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D019226', 'term': 'Oral Ulcer'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D011251', 'term': 'Pregnancy Complications, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D015337', 'term': 'Multicenter Studies as Topic'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-23', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the knowledge and belief about postpartum practice among the women', 'timeFrame': 'December 2009'}], 'secondaryOutcomes': [{'measure': 'Changes in the nutritional status, postpartum recovery and health status', 'timeFrame': 'June 2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Puerperal Infection', 'Fever', 'Constipation', 'Hemorrhoids', 'Anal Fissure', 'Breast Disease', 'Oral Ulcers', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '20187965', 'type': 'DERIVED', 'citation': 'Bao W, Ma A, Mao L, Lai J, Xiao M, Sun G, Ouyang Y, Wu S, Yang W, Wang N, Zhao Y, Fu J, Liu L. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial. BMC Public Health. 2010 Feb 27;10:103. doi: 10.1186/1471-2458-10-103.'}]}, 'descriptionModule': {'briefSummary': 'Previous studies have shown "Doing the month", a traditional practice for postpartum women in China and other Asian countries, may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women.', 'detailedDescription': 'The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n\\>=400) and the control group (n\\>=400). A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy pregnant women\n* at their third trimester\n* had at least three routine examinations at these antenatal clinics\n\nExclusion Criteria:\n\n* \\<20 or \\>40 years old'}, 'identificationModule': {'nctId': 'NCT01039051', 'briefTitle': 'Diet and Lifestyle Intervention Study in Postpartum Women in China', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': "Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health", 'orgStudyIdInfo': {'id': '2008BA158B07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet and Lifestyle counseling', 'description': 'increasing consumption of vegetables and fruits; maintaining energy balance through reducing excessive energy from meat, eggs and brown sugar and increasing energy expenditure from appropriate physical activity, such as doing maternal keep-fit exercises.', 'interventionNames': ['Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women']}], 'interventions': [{'name': 'Diet and Lifestyle Intervention in Chinese Postpartum Women', 'type': 'BEHAVIORAL', 'otherNames': ['Multicenter trial for Postpartum practice'], 'description': "For individual postpartum woman, we will set antepartum participatory training courses, provide specially prepared brochures and supporting VCD, set up a specialized counseling hotline and give individual bedside guidance after birth. For their family members, we will invite every postpartum woman's husband and mother to take part in workshops or seminars, making them know some basic knowledge of postpartum care, and persuading them to promote adoption of the diet and lifestyle we advocated by the postpartum woman. For community environment, we will put up posters about basic knowledge of postpartum care in the community bulletin boards for general population educating and mobilize community leaders and heads from and maternal and child health centers for maximum support.", 'armGroupLabels': ['Diet and Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Limei Mao, PhD', 'role': 'CONTACT'}, {'name': 'Limei Mao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liegang Liu, PhD', 'role': 'CONTACT', 'email': 'liegangliu@gmail.com', 'phone': '+86-27-83650522'}, {'name': 'Wei Bao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yingying Ouyang, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shuang Wu, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Yang, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yanting Zhao, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juan Fu, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '266021', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aiguo Ma, PhD', 'role': 'CONTACT'}, {'name': 'Aiguo Ma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Liegang Liu, PhD', 'role': 'CONTACT', 'email': 'liegangliu@gmail.com', 'phone': '+86-27-83650522'}], 'overallOfficials': [{'name': 'Liegang Liu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qingdao University', 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Liegang Liu', 'oldOrganization': 'Huazhong University of Science and Technology'}}}}