OverweightEarlySTOPP-CNNCT02396784
Early Stockholm Obesity Prevention Program (EarlySTOPP-China)
An observational study of Overweight and Obesity, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Early STOPP project promotes good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 1-6 yrs
Who may be able to join
- one obese or two overweight parents, 1 year old child
Who cannot join
- weight effecting diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity - China
Early STOPP project promotes good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.
Background: Several daily habits lead to less favorable health factors. For example, using the car instead of cycling or walking - leads to less activity in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.
Read more
Good treatment for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.
In Early STOPP project we study food, physical activity and sleep habits in the families with a child of one year of age. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured. Based on our observations we aim to develop the preventive strategies for the families with very young children.
- Conditions
- Overweight, Obesity
- Keywords
- child overweight, child obesity, prevention, targeted intervention, development of overweight
- Medical subject headings
- Overweight, Obesity, Pediatric Obesity
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 |
|---|---|---|
| High risk | One parent has a BMI of greater than or equal to 28, or both parents have a BMI of greater than or equal to 24 | |
| Normal risk | Both parents have a BMI of smaller than 24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index score(BMI sds) at the age 6 years
Weight gain, reflected in BMI sds will reflect the difference between two groups (case group and control group)
Measured: 5 years
Secondary outcomes (5)
sleeping hehavior
sleeping duration will be monitored to study its effect
Measured: 5 years
biomarkers
such as bacterial population in feces and in saliva
Measured: 5 years
physical activity and sedentary behavious
physical activity and sedentary behavious will be monitored
Measured: 5 years
dietary intake
changes in dietary habits and behaviour will be monitored
Measured: 5 years
socioeconomic factors
factors effecting obesity development will be assessed in order to understand their impacts
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2018 (estimated)
- 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 OverweightStudies 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
- Tanja Sobko, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396784
- Sponsor's protocol ID
- EarlySTOPP-CN
- Acronym
- EarlySTOPP-CN
- Status last verified
- Mar 2018
- First submitted
- 18 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
- A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity - China
- ClinicalTrials.gov ID
- NCT02396784
- Acronym / sponsor ID
- EarlySTOPP-CN / EarlySTOPP-CN
- Conditions
- Overweight, Obesity
- Keywords
- child overweight, child obesity, prevention, targeted intervention, development of overweight
- 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
- Jan 2011 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Mar 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.
Early STOPP project promotes good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.
Background: Several daily habits lead to less favorable health factors. For example, using the car instead of cycling or walking - leads to less activity in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.
Good treatment for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.
In Early STOPP project we study food, physical activity and sleep habits in the families with a child of one year of age. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured. Based on our observations we aim to develop the preventive strategies for the families with very young children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk | – | –One parent has a BMI of greater than or equal to 28, or both parents have a BMI of greater than or equal to 24 |
| Normal risk | – | –Both parents have a BMI of smaller than 24 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1-6 yrs
Key inclusion criteria (1 listed)
- one obese or two overweight parents, 1 year old child
Key exclusion criteria (1 listed)
- weight effecting diseases
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
Body Mass Index score(BMI sds) at the age 6 years
Time frame: 5 years
Weight gain, reflected in BMI sds will reflect the difference between two groups (case group and control group)
5 secondary outcomes
sleeping hehavior
Time frame: 5 years
biomarkers
Time frame: 5 years
physical activity and sedentary behavious
Time frame: 5 years
dietary intake
Time frame: 5 years
socioeconomic factors
Time frame: 5 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.
Tanja Sobko, PhD principal investigator
Karolinska Institutet
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 Overweight and 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 1 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?
Body Mass Index score(BMI sds) at the age 6 years (time frame: 5 years). 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.