Pediatric ObesityES-ChinaNCT02409875
The Early Stockholm Obesity Prevention Project in China
An observational study of Pediatric Obesity, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Obesity
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Obesity
- Keywords
- early intervention, obesity, body weight, body mass index, overnutrition, early promoters, genetic
- Medical subject headings
- Pediatric Obesity, Obesity, Body Weight, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Children BMI
With the annually measured children's weight and height, to calculate the BMI
Measured: 1 year
Children BMI
With the annually measured children's weight and height, to calculate the BMI
Measured: 2 years
Children BMI
With the annually measured children's weight and height, to calculate the BMI
Measured: 3 years
Secondary outcomes (1)
Association between children's eating habit, physical activity level, sleeping pattern and children's BMI
Using the collected data from questionnaires and accelerometer, to assess the association between the children's eating and physical activity habit with their growth
Measured: 1 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Jianduan Zhang, Huazhong University of Science and Technology
- Investigators
- Jianduan Zhang, Zhang, Study director, Huazhong University of Science and Technology, Tongji Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409875
- Sponsor's protocol ID
- ES-2010
- Acronym
- ES-China
- Status last verified
- Mar 2018
- First submitted
- 27 Mar 2015
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby-STOPP: Targeted Obesity Prevention Directed to Overweight Parents With Young Children
- ClinicalTrials.gov ID
- NCT02409875
- Acronym / sponsor ID
- ES-China / ES-2010
- Conditions
- Pediatric Obesity
- Keywords
- early intervention, obesity, body weight, body mass index, overnutrition, early promoters, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Feb 2011 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Apr 2015 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Children BMI
Time frame: 1 year
With the annually measured children's weight and height, to calculate the BMI
Children BMI
Time frame: 2 years
With the annually measured children's weight and height, to calculate the BMI
Children BMI
Time frame: 3 years
With the annually measured children's weight and height, to calculate the BMI
1 secondary outcome
Association between children's eating habit, physical activity level, sleeping pattern and children's BMI
Time frame: 1 to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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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.
Jianduan Zhang, Zhang study director
Huazhong University of Science and Technology, Tongji Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by Huazhong University of Science and Technology at 1 site 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 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children BMI (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2018.