Early Stockholm Obesity Prevention Program (EarlySTOPP-China)

Obesity Clinical Trial

— EarlySTOPP-CN  

Official title:

A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity - China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02396784
• Other study ID #: EarlySTOPP-CN
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2015
• Last updated: March 2, 2018
• Start date: January 2011
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• weight effecting diseases

Related Conditions & MeSH terms

• Obesity
• Overweight

Locations

Country	Name	City	State
China	Tongji Medical College	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Karolinska Institutet

Country where clinical trial is conducted

China, 

Outcome

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