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
  Purpose

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 Intervention
Childhood Obesity
Behavioral: mandometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Bristol:

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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 90
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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407420

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

No publications provided by University of Bristol

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00407420     History of Changes
Other Study ID Numbers: RJ4316
Study First Received: December 1, 2006
Last Updated: December 4, 2006
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Bristol:
Childhood
Obesity
Behavior modification
Insulin resistance

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

ClinicalTrials.gov processed this record on April 15, 2014