Trial of the MEND Childhood Obesity Treatment Program

Obesity Clinical Trial

— MEND  

Official title:

MEND Childhood Obesity Treatment Programme: An RCT to Improve Body Composition and Cardiovascular Health in Overweight and Obese Children.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00974116
• Other study ID #: 08NT07
• Status: Not yet recruiting
• Phase: N/A
• First received: September 7, 2009
• Last updated: September 9, 2009
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: September 2009
• Source: Institute of Child Health
• Contact: Sally Barber, PhD
• Email: s.barber[@]ich.ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The Study is a Randomised Controlled Trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 13 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• MEND Childhood Obesity Program
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.
• Control Group
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index z-score		6 months	No
Secondary	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	No