The Early Stockholm Obesity Prevention Project in China

Pediatric Obesity Clinical Trial

— ES-China  

Official title:

Baby-STOPP: Targeted Obesity Prevention Directed to Overweight Parents With Young Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02409875
• Other study ID #: ES-2010
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2015
• Last updated: March 2, 2018
• Start date: February 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

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

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	Children BMI	With the annually measured children's weight and height, to calculate the BMI	1 year
Primary	Children BMI	With the annually measured children's weight and height, to calculate the BMI	2 years
Primary	Children BMI	With the annually measured children's weight and height, to calculate the BMI	3 years
Secondary	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	1 to 3 years