Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407420
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2006-12-01
Brief Title:
Mandometer Study for Managing Childhood Obesity
Sponsor:
University of Bristol
Organization:
University of Bristol
Study Overview
Official Title:
Can a Novel Treatment Using Mandometer Technology Improve Weight Loss in a Childhood Obesity Clinic
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None