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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407420
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : December 5, 2006
Information provided by:
University of Bristol

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: mandometer Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Primary Outcome Measures :
  1. Change in Body Mass Index Standard Deviation Score

Secondary Outcome Measures :
  1. biochemical parameters including insulin sensitivity using glucose and insulin measures,
  2. physical activity measured by CSA,
  3. State of well-being,
  4. rate of eating and grams of food consumed in Mandometer® arm,
  5. fat free mass (Bio-impedance)

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Obese children and adolescents aged 10-18

Exclusion Criteria:


  • Having associated learning difficulties
  • Who have received medication for associated insulin resistance
  • Refusal of parent/legal guardian to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407420

United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8AE
Sponsors and Collaborators
University of Bristol
Principal Investigator: Julian P Hamilton-Shield, MD University of Bristol and Bristol Royal Hospital for Children

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00407420     History of Changes
Other Study ID Numbers: RJ4316
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: December 5, 2006
Last Verified: December 2006

Keywords provided by University of Bristol:
Behavior modification
Insulin resistance

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