Clinical Trial: Diet and Lifestyle Intervention Study in Postpartum Women in China

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Huazhong University of Science and Technology

Current Primary Outcome: Changes in the knowledge and belief about postpartum practice among the women [ Time Frame: December 2009 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in the nutritional status, postpartum recovery and health status [ Time Frame: June 2010 ]

Original Secondary Outcome: Same as current

Information By: Huazhong University of Science and Technology

Dates:
Date Received: December 22, 2009
Date Started: June 2009
Date Completion: June 2010
Last Updated: December 23, 2009
Last Verified: December 2009