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Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?

This study has been completed.
Sponsor:
Information provided by:
University of Bristol
ClinicalTrials.gov Identifier:
NCT00407420
First received: December 1, 2006
Last updated: December 4, 2006
Last verified: December 2006

December 1, 2006
December 4, 2006
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Change in Body Mass Index Standard Deviation Score
Same as current
Complete list of historical versions of study NCT00407420 on ClinicalTrials.gov Archive Site
  • biochemical parameters including insulin sensitivity using glucose and insulin measures,
  • physical activity measured by CSA,
  • State of well-being,
  • rate of eating and grams of food consumed in Mandometer® arm,
  • fat free mass (Bio-impedance)
Same as current
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Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?
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We run a successful clinic in Bristol for children with severe obesity who already demonstrate many features to suggest they are at increased risk of early diabetes and heart disease. However, we have found that young children respond better to simple interventions than do adolescents. We have used a new treatment regimen "Mandometer®" to help our most difficult adolescent cases lose weight. We would like to do a study to see if all adolescents might improve weight loss using this technology compared to what we routinely offer

Childhood obesity is rapidly reaching epidemic proportions in the United Kingdom. Recent studies have indicated a prevalence level for obesity of 15% at 15 years of age. The implications for metabolic, cardiovascular and cancer risk in later life are enormous. The International Obesity Task Force (IOTF) and the European Association for the Study of Obesity (EASO) have identified childhood obesity as a matter for urgent attention. However, there are very few obesity clinics for children in the UK and effective treatment regimens are simply not available. We have developed an obesity clinic at the Royal Hospital for Children in Bristol and observed effective weight reduction in pre-pubertal children. Our simple treatment framework has proved far less effective in adolescence. We have therefore collaborated with an eating disorder clinic from the Karolinska Institute in Sweden to develop a novel therapy to treat obesity using modified equipment originally designed to treat adolescents with DSM-IV eating disorders. Pilot data indicate that adolescents are better able to address the issue of weight reduction within this treatment modality. Having established the software and treatment process we now wish to perform a randomised, control trial to test the efficacy of this new treatment against that currently provided.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Childhood Obesity
Behavioral: mandometer
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Ford AL, Bergh C, Södersten P, Sabin MA, Hollinghurst S, Hunt LP, Shield JP. Treatment of childhood obesity by retraining eating behaviour: randomised controlled trial. BMJ. 2009 Jan 5;340:b5388. doi: 10.1136/bmj.b5388.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
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Inclusion Criteria:

  • Obese children and adolescents aged 10-18

Exclusion Criteria:

Children:

  • Having associated learning difficulties
  • Who have received medication for associated insulin resistance
  • Refusal of parent/legal guardian to give informed consent.
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00407420
RJ4316
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University of Bristol
Not Provided
Principal Investigator: Julian P Hamilton-Shield, MD University of Bristol and Bristol Royal Hospital for Children
University of Bristol
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP