Diet and Lifestyle Intervention Study in Postpartum Women in China

NCT ID: NCT01039051

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Puerperal Infection Fever Constipation Hemorrhoids Anal Fissure Breast Disease Oral Ulcers Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Diet and Lifestyle Intervention in Chinese Postpartum Women

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Multicenter trial for Postpartum practice

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Qingdao University

OTHER

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Huazhong University of Science and Technology

Principal Investigators

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Liegang Liu, PhD

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liegang Liu, PhD

Role: CONTACT

Phone: +86-27-83650522

Email: [email protected]

Facility Contacts

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Limei Mao, PhD

Role: primary

Liegang Liu, PhD

Role: primary

Aiguo Ma, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 20187965 (View on PubMed)

Other Identifiers

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2008BA158B07

Identifier Type: -

Identifier Source: org_study_id