Trial of the MEND Childhood Obesity Treatment Program

NCT ID: NCT00974116

Last Updated: 2009-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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The Study is a Randomised Controlled Trial.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BEHAVIORAL

Control Group

No intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Responsible Party

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Institute of Child Health

Principal Investigators

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Prof Atul Singhal

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health

Central Contacts

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Sally Barber, PhD

Role: CONTACT

Other Identifiers

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08NT07

Identifier Type: -

Identifier Source: org_study_id

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