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Trial of the MEND Childhood Obesity Treatment Program (MEND)

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MEND Childhood Obesity Program
Control Group
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Body Mass Index z-score

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 7, 2009
    Last Updated
    September 9, 2009
    Sponsor
    Institute of Child Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00974116
    Brief Title
    Trial of the MEND Childhood Obesity Treatment Program
    Acronym
    MEND
    Official Title
    MEND Childhood Obesity Treatment Programme: An RCT to Improve Body Composition and Cardiovascular Health in Overweight and Obese Children.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 2013 (Anticipated)
    Study Completion Date
    January 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Institute of Child Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    MEND Childhood Obesity Program
    Intervention Description
    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
    Intervention Name(s)
    Control Group
    Intervention Description
    No intervention
    Primary Outcome Measure Information:
    Title
    Body Mass Index z-score
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sally Barber, PhD
    Email
    s.barber@ich.ucl.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prof Atul Singhal
    Organizational Affiliation
    Institute of Child Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of the MEND Childhood Obesity Treatment Program

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