Puerperal InfectionPhase 2/3NCT01039051
Diet and Lifestyle Intervention Study in Postpartum Women in China
A Phase 2/3 study testing Diet and Lifestyle Intervention in Chinese Postpartum Women in people with Puerperal Infection and Fever, run by Huazhong University of Science and Technology at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Puerperal Infection, Fever, Constipation
- What is being tested?
- Diet and Lifestyle Intervention in Chinese Postpartum Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2009to Jun 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy pregnant women
- at their third trimester
- had at least three routine examinations at these antenatal clinics
Who cannot join
- <20 or >40 years old
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Southern Medical University
Guangzhou, Guangdong, 510515
Limei Mao, PhD
Limei Mao, PhD
- Recruiting
Qingdao University
Qingdao, Shandong, 266021
Aiguo Ma, PhD
Aiguo Ma, PhD
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Liegang Liu, PhD, +86-27-83650522, liegangliu@gmail.com
Wei Bao, PhD
About this study
Official title: Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health
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.
Read the 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.
- Conditions
- Puerperal Infection, Fever, Constipation, Hemorrhoids, Anal Fissure, Breast Disease
- Being tested
- Diet and Lifestyle Intervention in Chinese Postpartum Women
- Medical subject headings
- Puerperal Infection, Fever, Constipation, Hemorrhoids, Fissure in Ano, Breast Diseases, Oral Ulcer, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and Lifestyle Intervention in Chinese Postpartum WomenBehavioural
Also called Multicenter trial for Postpartum practice
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet and Lifestyle counseling | Experimental | 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. Receives: Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the knowledge and belief about postpartum practice among the women
Measured: December 2009
Secondary outcomes (1)
Changes in the nutritional status, postpartum recovery and health status
Measured: June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Puerperal InfectionStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao University, Southern Medical University, China, Centers for Disease Control and Prevention, China
- Investigators
- Liegang Liu, PhD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039051
- Sponsor's protocol ID
- 2008BA158B07
- Status last verified
- Dec 2009
- First submitted
- 22 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20187965
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials of Diet and Lifestyle Intervention to Promote Chinese Postpartum Women's Health
- ClinicalTrials.gov ID
- NCT01039051
- Acronym / sponsor ID
- 2008BA158B07
- Conditions
- Puerperal Infection, Fever, Constipation, Hemorrhoids, Anal Fissure, Breast Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Qingdao University, Southern Medical University, China, Centers for Disease Control and Prevention, China
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet and Lifestyle counseling | Experimental | Behavioral: Diet and Lifestyle Intervention in Chinese Postpartum Womenincreasing 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy pregnant women
- at their third trimester
- had at least three routine examinations at these antenatal clinics
Key exclusion criteria (1 listed)
- <20 or >40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and Lifestyle Intervention in Chinese Postpartum WomenAlso: Multicenter trial for Postpartum practiceFor 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. | Behavioural | Diet and Lifestyle counseling |
Primary outcome
Changes in the knowledge and belief about postpartum practice among the women
Time frame: December 2009
1 secondary outcome
Changes in the nutritional status, postpartum recovery and health status
Time frame: June 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Derived from this study: PubMed 20187965Bao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liegang Liu, PhD study chair
Huazhong University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diet and Lifestyle Intervention in Chinese Postpartum Women in people with Puerperal Infection and Fever, run by Huazhong University of Science and Technology at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liegang Liu, PhD (+86-27-83650522, liegangliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the knowledge and belief about postpartum practice among the women (time frame: December 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.