Diet and Lifestyle Intervention Study in Postpartum Women in China
Primary Purpose
Puerperal Infection, Fever, Constipation
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Diet and Lifestyle Intervention in Chinese Postpartum Women
Sponsored by
About this trial
This is an interventional prevention trial for Puerperal Infection
Eligibility Criteria
Inclusion Criteria:
- healthy pregnant women
- at their third trimester
- had at least three routine examinations at these antenatal clinics
Exclusion Criteria:
- <20 or >40 years old
Sites / Locations
- Southern Medical UniversityRecruiting
- Huazhong University of Science and TechnologyRecruiting
- Qingdao UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diet and Lifestyle counseling
Arm 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.
Outcomes
Primary Outcome Measures
Changes in the knowledge and belief about postpartum practice among the women
Secondary Outcome Measures
Changes in the nutritional status, postpartum recovery and health status
Full Information
NCT ID
NCT01039051
First Posted
December 22, 2009
Last Updated
December 23, 2009
Sponsor
Huazhong University of Science and Technology
Collaborators
Qingdao University, Southern Medical University, China, Centers for Disease Control and Prevention, China
1. Study Identification
Unique Protocol Identification Number
NCT01039051
Brief Title
Diet and Lifestyle Intervention Study in Postpartum Women in China
Official Title
Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Qingdao University, Southern Medical University, China, Centers for Disease Control and Prevention, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Puerperal Infection, Fever, Constipation, Hemorrhoids, Anal Fissure, Breast Disease, Oral Ulcers, Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet and Lifestyle counseling
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Diet and Lifestyle Intervention in Chinese Postpartum Women
Other Intervention Name(s)
Multicenter trial for Postpartum practice
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in the knowledge and belief about postpartum practice among the women
Time Frame
December 2009
Secondary Outcome Measure Information:
Title
Changes in the nutritional status, postpartum recovery and health status
Time Frame
June 2010
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy pregnant women
at their third trimester
had at least three routine examinations at these antenatal clinics
Exclusion Criteria:
<20 or >40 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liegang Liu, PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liegang Liu, PhD
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limei Mao, PhD
First Name & Middle Initial & Last Name & Degree
Limei Mao, PhD
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liegang Liu, PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei Bao, PhD
First Name & Middle Initial & Last Name & Degree
Yingying Ouyang, Master
First Name & Middle Initial & Last Name & Degree
Shuang Wu, Master
First Name & Middle Initial & Last Name & Degree
Wei Yang, PhD
First Name & Middle Initial & Last Name & Degree
Yanting Zhao, Master
First Name & Middle Initial & Last Name & Degree
Juan Fu, Master
Facility Name
Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiguo Ma, PhD
First Name & Middle Initial & Last Name & Degree
Aiguo Ma, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
20187965
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.
Results Reference
derived
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Diet and Lifestyle Intervention Study in Postpartum Women in China
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