Trial of the MEND Childhood Obesity Treatment Program

Not Applicable

• Conditions: Obesity

• Registration Number: NCT00974116
• Lead Sponsor: Institute of Child Health

Brief Summary

The number of children who are obese in the UK is steadily increasing with both short and long term consequences for health. The aim of this study is to determine whether the MEND Programme (a new national initiative for the treatment of childhood obesity) is a successful and sustainable treatment for childhood obesity and obesity related health problems.

300 overweight and obese children will be randomly assigned to start immediately on the MEND Programme for 6 months or join a waiting-list control group for 6 months. Measurements of health outcomes will be taken at baseline, and at 6, 12 and 24 months after the Programme. After 6 months of waiting-list time, the control group will follow the same protocol as the immediate starters. The researchers will be unaware (blinded) to which group each child has been assigned to. The study will examine the effects of the MEND Programme on body composition, cardiovascular health and psychological health.

Detailed Description

The Study is a Randomised Controlled Trial.

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-09-09
• Last Update Submitted: 2009-09-09
• Study First Posted: 2009-09-10
• Last Update Posted: 2009-09-10
• Study Start: 2010-01
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Children enrolled in the MEND Programme who are yet to be given a start date for the programme.
• Aged between 7-13 years old.
• Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1).
• Clinically well with no known chronic illness.

Exclusion Criteria

• Age less than 7 years or older than 13.
• Known chronic illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Body Mass Index z-score	6 months

Secondary Outcome Measures

Name	Time	Method
Body fat, waist circumference, blood pressure, arterial stiffness, heart rate control, fitness, physical activity and sedentary behaviour status, self esteem and health related quality of life.	6 months