Clinical trial NCT00407420: "Mandometer®" Study for Managing Childhood Obesity
Official title: Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood
Obesity
Behavior modification
Insulin resistance
Lead sponsor: University of Bristol
Sponsor class: OTHER
First posted: 2006-12-05
Enrollment: 106
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: BMI SDS or Z-score
timeFrame: 12 months primary/ 18 months secondary outcome
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: 12 months
measure: Speed Food Consumed
timeFrame: 12 months
measure: Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
Study officials:
affiliation: University of Bristol and Bristol Royal Hospital for Children
name: Julian P Hamilton-Shield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ford AL, Bergh C, Sodersten 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.