Early Stockholm Obesity Prevention Program (EarlySTOPP-China) (EarlySTOPP-CN)

March 2, 2018 updated by: Jianduan Zhang, Huazhong University of Science and Technology

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.

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 Overview

Status

Unknown

Conditions

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

  • China
    • 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

1 year to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children aged 1-6 yrs

Description

Inclusion Criteria:

  • one obese or two overweight parents, 1 year old child

Exclusion Criteria:

  • weight effecting diseases

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dietary intake
Time Frame: 5 years
changes in dietary habits and behaviour will be monitored
5 years
sleeping hehavior
Time Frame: 5 years
sleeping duration will be monitored to study its effect
5 years
biomarkers
Time Frame: 5 years
such as bacterial population in feces and in saliva
5 years
physical activity and sedentary behavious
Time Frame: 5 years
physical activity and sedentary behavious will be monitored
5 years
socioeconomic factors
Time Frame: 5 years
factors effecting obesity development will be assessed in order to understand their impacts
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Tanja Sobko, PhD, Karolinska Institutet

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)

January 1, 2011

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 24, 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

  • EarlySTOPP-CN

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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