Clinical trial NCT01039051: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Puerperal Infection
Fever
Constipation
Hemorrhoids
Anal Fissure
Breast Disease
Oral Ulcers
Anemia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Qingdao University
name: Southern Medical University, China
name: Centers for Disease Control and Prevention, China
First posted: 2009-12-24
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in the knowledge and belief about postpartum practice among the women
timeFrame: December 2009
Secondary outcomes:
measure: Changes in the nutritional status, postpartum recovery and health status
timeFrame: June 2010
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
city: Qingdao
country: China
facility: Qingdao University
state: Shandong
Study officials:
affiliation: Huazhong University of Science and Technology
name: Liegang Liu, PhD
role: STUDY_CHAIR
References:
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.