Trial of the MEND Childhood Obesity Treatment Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Institute of Child Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00974116
First received: September 7, 2009
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Obesity
Behavioral: MEND Childhood Obesity Program
Behavioral: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MEND Childhood Obesity Treatment Programme: An RCT to Improve Body Composition and Cardiovascular Health in Overweight and Obese Children.

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Body Mass Index z-score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Behavioral: Control Group
    No intervention
Detailed Description:

The Study is a Randomised Controlled Trial.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974116

Contacts
Contact: Sally Barber, PhD s.barber@ich.ucl.ac.uk

Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Prof Atul Singhal Institute of Child Health
  More Information

No publications provided

Responsible Party: Professor Atul Singhal, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00974116     History of Changes
Other Study ID Numbers: 08NT07
Study First Received: September 7, 2009
Last Updated: September 9, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014