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Diet and Lifestyle Intervention Study in Postpartum Women in China

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01039051
Enrollment
1600
Registered
2009-12-24
Start date
2009-06-30
Completion date
2010-06-30
Last updated
2009-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALDiet 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.

Sponsors

Qingdao University
CollaboratorOTHER
Southern Medical University, China
CollaboratorOTHER
Centers for Disease Control and Prevention, China
CollaboratorOTHER_GOV
Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in the knowledge and belief about postpartum practice among the womenDecember 2009

Secondary

MeasureTime frame
Changes in the nutritional status, postpartum recovery and health statusJune 2010

Countries

China

Contacts

Primary ContactLiegang Liu, PhD
liegangliu@gmail.com+86-27-83650522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026