Diet and Lifestyle Intervention Study in Postpartum Women in China

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Huazhong University of Science and Technology.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Qingdao University

Southern Medical University, China

Centers for Disease Control and Prevention, China

Information provided by:

Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01039051

First received: December 22, 2009

Last updated: December 23, 2009

Last verified: December 2009

History of Changes

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health

Resource links provided by NLM:

MedlinePlus related topics: Anemia Breast Diseases Constipation Fever Hemorrhoids Postpartum Care Women's Health

U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:

Changes in the knowledge and belief about postpartum practice among the women [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in the nutritional status, postpartum recovery and health status [ Time Frame: June 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1600
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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

Ages Eligible for Study:	20 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039051

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

No publications provided by Huazhong University of Science and Technology

Additional 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.

Responsible Party:	Liegang Liu, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01039051 History of Changes
Other Study ID Numbers:	2008BA158B07
Study First Received:	December 22, 2009
Last Updated:	December 23, 2009
Health Authority:	China: Ministry of Health

Additional relevant MeSH terms:

Anemia
Breast Diseases
Constipation
Fissure in Ano
Hemorrhoids
Puerperal Infection
Ulcer
Oral Ulcer
Hematologic Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Anus Diseases

Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications, Infectious
Infection
Pregnancy Complications
Puerperal Disorders
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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