Diet and Lifestyle Intervention Study in Postpartum Women in China

Phase 2

• Conditions: Puerperal Infection; Fever; Constipation; Hemorrhoids; Anal Fissure; Breast Disease; Oral Ulcers; Anemia
• Interventions: Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women

• Registration Number: NCT01039051
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Last Update Submitted: 2009-12-23
• Study First Posted: 2009-12-24
• Last Update Posted: 2009-12-24
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and Lifestyle counseling	Diet and Lifestyle Intervention in Chinese Postpartum Women	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.

Primary Outcome Measures

Name	Time	Method
Changes in the knowledge and belief about postpartum practice among the women	December 2009

Secondary Outcome Measures

Name	Time	Method
Changes in the nutritional status, postpartum recovery and health status	June 2010

Trial Locations

Locations (3)

Qingdao University; 🇨🇳 Qingdao, Shandong, China

Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China