Diet and Lifestyle Intervention Study in Postpartum Women in China
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| ClinicalTrials.gov Identifier: NCT01039051 |
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Recruitment Status : Unknown
Verified December 2009 by Huazhong University of Science and Technology.
Recruitment status was: Recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
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Sponsor:
Huazhong University of Science and Technology
Collaborators:
Qingdao University
Southern Medical University, China
Centers for Disease Control and Prevention, China
Information provided by:
Huazhong University of Science and Technology
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Postpartum Care
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
Primary Outcome Measures :
- Changes in the knowledge and belief about postpartum practice among the women [ Time Frame: December 2009 ]
Secondary Outcome Measures :
- Changes in the nutritional status, postpartum recovery and health status [ Time Frame: June 2010 ]
Information from the National Library of Medicine
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| Last Update Posted: | December 24, 2009 |
| Last Verified: | December 2009 |
Additional relevant MeSH terms:
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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 |