"Mandometer®" Study for Managing Childhood Obesity

NCT ID: NCT00407420

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2013-01-31

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mandometer

Active intervention - one meal eaten per day off Mandometer

Group Type: EXPERIMENTAL

Mandometer

Intervention Type: DEVICE

A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy.

Lifestyle

Intervention Type: BEHAVIORAL

Typical dietary and activity advice as normally provided in clinic (control).

Control

Nutritional and activity advice alone

Group Type: ACTIVE_COMPARATOR

Mandometer

Intervention Type: DEVICE

A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy.

Interventions

Mandometer

A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy.

Intervention Type: DEVICE

Lifestyle

Typical dietary and activity advice as normally provided in clinic (control).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bristol

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian P Hamilton-Shield, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bristol and Bristol Royal Hospital for Children

Locations

Bristol Royal Hospital for Children

Bristol, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 20051465 (View on PubMed)

Other Identifiers

RJ4316

Identifier Type: -

Identifier Source: org_study_id