Diet and Lifestyle Intervention Study in Postpartum Women in China

December 23, 2009 updated by: Huazhong University of Science and Technology

Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University
        • Contact:
          • Limei Mao, PhD
        • Principal Investigator:
          • Limei Mao, PhD
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Wei Bao, PhD
        • Principal Investigator:
          • Yingying Ouyang, Master
        • Principal Investigator:
          • Shuang Wu, Master
        • Sub-Investigator:
          • Wei Yang, PhD
        • Sub-Investigator:
          • Yanting Zhao, Master
        • Sub-Investigator:
          • Juan Fu, Master
    • Shandong
      • Qingdao, Shandong, China, 266021
        • Recruiting
        • Qingdao University
        • Contact:
          • Aiguo Ma, PhD
        • Principal Investigator:
          • Aiguo Ma, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet and Lifestyle counseling
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.
Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women
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.
Other Names:
  • Multicenter trial for Postpartum practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the knowledge and belief about postpartum practice among the women
Time Frame: December 2009
December 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the nutritional status, postpartum recovery and health status
Time Frame: June 2010
June 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

Qingdao University
Southern Medical University, China
Centers for Disease Control and Prevention, China

Investigators

  • Study Chair: Liegang Liu, PhD, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008BA158B07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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