Diet and Lifestyle Intervention Study in Postpartum Women in China

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01039051
• Other study ID #: 2008BA158B07
• 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

Related Conditions & MeSH terms

• Anal Fissure
• Anemia
• Breast Disease
• Breast Diseases
• Constipation
• Fever
• Fissure in Ano
• Hemorrhoids
• Oral Ulcer
• Oral Ulcers
• Puerperal Infection

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