Diet and Lifestyle Intervention Study in Postpartum Women in China

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Puerperal Infection; Fever; Constipation; Hemorrhoids; Anal Fissure; Breast Disease; Oral Ulcers; Anemia	Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women	Phase 2; Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health
Study Start Date :	June 2009
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	June 2010

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Diet and Lifestyle counseling; 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.

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.; Other Name: Multicenter trial for Postpartum practice

Outcome Measures

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Primary Outcome Measures :

1. Changes in the knowledge and belief about postpartum practice among the women [ Time Frame: December 2009 ]

Secondary Outcome Measures :

1. Changes in the nutritional status, postpartum recovery and health status [ Time Frame: June 2010 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Liegang Liu, PhD	+86-27-83650522	liegangliu@gmail.com

Locations

China, Guangdong
Southern Medical University	Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Limei Mao, PhD
Principal Investigator: Limei Mao, PhD
China, Hubei
Huazhong University of Science and Technology	Recruiting
Wuhan, Hubei, China, 430030
Contact: Liegang Liu, PhD +86-27-83650522 liegangliu@gmail.com
Principal Investigator: Wei Bao, PhD
Principal Investigator: Yingying Ouyang, Master
Principal Investigator: Shuang Wu, Master
Sub-Investigator: Wei Yang, PhD
Sub-Investigator: Yanting Zhao, Master
Sub-Investigator: Juan Fu, Master
China, Shandong
Qingdao University	Recruiting
Qingdao, Shandong, China, 266021
Contact: Aiguo Ma, PhD
Principal Investigator: Aiguo Ma, PhD

Sponsors and Collaborators

Huazhong University of Science and Technology

Qingdao University

Southern Medical University, China

Centers for Disease Control and Prevention, China

Investigators

Study Chair:	Liegang Liu, PhD	Huazhong University of Science and Technology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Liegang Liu, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01039051 History of Changes
Other Study ID Numbers:	2008BA158B07
First Posted:	December 24, 2009
Last Update Posted:	December 24, 2009
Last Verified:	December 2009

Additional relevant MeSH terms:

Constipation; Hemorrhoids; Breast Diseases; Fissure in Ano; Oral Ulcer; Puerperal Infection; Signs and Symptoms, Digestive; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases	Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Anus Diseases; Mouth Diseases; Stomatognathic Diseases; Pregnancy Complications, Infectious; Infection; Pregnancy Complications; Puerperal Disorders