- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02409875
The Early Stockholm Obesity Prevention Project in China (ES-China)
March 2, 2018 updated by: Jianduan Zhang, Huazhong University of Science and Technology
Baby-STOPP: Targeted Obesity Prevention Directed to Overweight Parents With Young Children
This is a cohort study where families with infants are followed closely for three years.
It aims to assess if parental weight status (normal weight vs. overweight/obesity), their physical activity and eating habit will influence their young children's growth and be helpful in childhood obesity reducing.
Study Overview
Status
Unknown
Conditions
Detailed Description
The aimed 300 families are invited with half parents in high risk group (one of the parents with BMI>=28 or both 28>BMI>=24) and half in low risk group (both parents with BMI<24 or one parent 28>BMI>=24) living in Wuhan City.
Maternal and paternal prepregnancy weight and height are recruited through the Children Systematic Health Management System before the child's first birthday.
After getting an oral agreement, a later on family visit will be done by trained staffs.
The home visit contains anthropometrics measurement, including weight, height, head circumference, abdominal circumference for both parents and children and blood pressure for parents; it also has some questionnaires that have children's condition during the first years, the caring status, parents' characteristic information, the eating, physical activity and sleeping habits for both parents and children, children's seven day 24 hours' sleeping record in the coming week; at the same time, objectively measured physical activity for parents and children will be done for seven days with accelerometers.
The annual visit will range 15 days before or after the children's birthday, and this will begin from the children age one and followed up to aged three.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Families living in Wuhan city, having an one year old child, willing to participanted are welcomed to the study.
A total of 300 simple size with half high-risk group and half in low-risk group is anticipated.
Description
Inclusion Criteria:
- a child in the household being 1 year old (±3 months) at the time of recruitment;
- the parents were Wuhan registered residents;
- the child had no chronic health condition affecting growth, physical activity or eating habits.
Exclusion Criteria:
- none.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Risk groups
For families that both parents have BMI>=24 or at least one of them BMI>=28, then calculated as high-risk group. For families that both parents have BMI<24 or one parents with BMI<24 and one with 24<=BMI<28, then grouped as low-risk group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children BMI
Time Frame: 1 year
|
With the annually measured children's weight and height, to calculate the BMI
|
1 year
|
Children BMI
Time Frame: 2 years
|
With the annually measured children's weight and height, to calculate the BMI
|
2 years
|
Children BMI
Time Frame: 3 years
|
With the annually measured children's weight and height, to calculate the BMI
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between children's eating habit, physical activity level, sleeping pattern and children's BMI
Time Frame: 1 to 3 years
|
Using the collected data from questionnaires and accelerometer, to assess the association between the children's eating and physical activity habit with their growth
|
1 to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jianduan Zhang, Zhang, Huazhong University of Science and Technology, Tongji Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
March 27, 2015
First Submitted That Met QC Criteria
April 1, 2015
First Posted (Estimate)
April 7, 2015
Study Record Updates
Last Update Posted (Actual)
March 5, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ES-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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