Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?
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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 |
- Change in Body Mass Index Standard Deviation Score
- 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 |
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 |
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| United Kingdom | |
| Bristol Royal Hospital for Children | |
| Bristol, United Kingdom, BS2 8AE | |
| 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 May 22, 2013