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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01039051
Other study ID # 2008BA158B07
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 22, 2009
Last updated December 23, 2009
Start date June 2009
Est. completion date June 2010

Study information

Verified date December 2009
Source Huazhong University of Science and Technology
Contact Liegang Liu, PhD
Phone +86-27-83650522
Email liegangliu@gmail.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

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.

Locations

Country Name City State
China Southern Medical University Guangzhou Guangdong
China Qingdao University Qingdao Shandong
China Huazhong University of Science and Technology Wuhan Hubei

Sponsors (4)

Lead Sponsor Collaborator
Huazhong University of Science and Technology Centers for Disease Control and Prevention, China, Qingdao University, Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the knowledge and belief about postpartum practice among the women December 2009 Yes
Secondary Changes in the nutritional status, postpartum recovery and health status June 2010 Yes
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