Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000549426
Ethics application status
Approved
Date submitted
22/10/2007
Date registered
25/10/2007
Date last updated
25/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Health and Nutrition Education Intervention on postpartum practices
Scientific title
The effect of Health and Nutrition Education Intervention on postpartum practices: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum behaviors 2493 0
Condition category
Condition code
Public Health 2590 2590 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The nutrition and health education intervention consists of two, two hour education sessions. It focuses on healthy eating and lifestyle during puerperium, basic knowledge on nutrition, general concepts on balanced diet, optimal hygiene behavior and physical exercise patterns during postpartum period.
Intervention code [1] 2221 0
Behaviour
Comparator / control treatment
The control group doesn't receive the intervention but were exposed to the normal standard of care available during the delivery and postpartum period.
Control group
Active

Outcomes
Primary outcome [1] 3502 0
Postpartum health behaviors, physical activities and health problems.
Timepoint [1] 3502 0
42 days postpartum.
Secondary outcome [1] 5847 0
Dietary behavior according to the food record during the postpartum period.
Timepoint [1] 5847 0
42 days postpartum.

Eligibility
Key inclusion criteria
Healthy pregnant women at the third trimester.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Complicated pregnancy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment outside Australia
Country [1] 632 0
China
State/province [1] 632 0

Funding & Sponsors
Funding source category [1] 2743 0
Commercial sector/Industry
Name [1] 2743 0
Danone
Country [1] 2743 0
China
Primary sponsor type
University
Name
Limei Mao
Address
Department of Nutrition and Food Hygiene
School of Public Health
Tongji Medical College
Huazhong University of Science & Technology
13 Hangkong Road
Wuhan 430030
Country
China
Secondary sponsor category [1] 2478 0
None
Name [1] 2478 0
Address [1] 2478 0
Country [1] 2478 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
‘Sitting month’ is the Chinese tradition for postpartum customs. Available studies indicate that some of the traditional postpartum practices are potentially harmful for women’s health. The study aimed to assess the effect of a health and nutrition education intervention, which focused on improving postpartum dietary quality and optimal health behaviors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28138 0
Address 28138 0
Country 28138 0
Phone 28138 0
Fax 28138 0
Email 28138 0
Contact person for public queries
Name 11295 0
Nian Liu
Address 11295 0
Department of Nutrition and Food Hygiene
School of Public Health
Tongji Medical College
Huazhong University of Science & Technology
13 Hangkong Road
Wuhan 430030
Country 11295 0
China
Phone 11295 0
+86 27 61332056
Fax 11295 0
Email 11295 0
[email protected]
Contact person for scientific queries
Name 2223 0
Limei Mao
Address 2223 0
Department of Nutrition and Food Hygiene
School of Public Health
Tongji Medical College
Huazhong University of Science & Technology
13 Hangkong Road
Wuhan 430030
Country 2223 0
China
Phone 2223 0
+86 27 83692711
Fax 2223 0
Email 2223 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.