"Mandometer®" Study for Managing Childhood Obesity

University of Bristol

Status: Completed

Conditions: Childhood Obesity

Treatments: Device: Mandometer; Behavioral: Lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT00407420

RJ4316

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Mandometer

Experimental group

Description:

Active intervention - one meal eaten per day off Mandometer

Treatment:

Behavioral: Lifestyle

Device: Mandometer

Control

Active Comparator group

Description:

Nutritional and activity advice alone

Treatment:

Device: Mandometer