NCT00407420

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

September 30, 2019

Completed
Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

December 1, 2006

Results QC Date

January 19, 2018

Last Update Submit

September 27, 2019

Conditions

Childhood Obesity

Keywords

ChildhoodObesityBehavior modificationInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • BMI SDS or Z-score

    Body Mass Index standard deviation (s.d.) scores also called Z-scores, are measures of relative weight adjusted for a child's age and sex. In terms of this score for weight management, a lower score would be viewed a beneficial outcome at the end of the intervention. The change in BMI SDS was calculated as the value at 12 months minus value at baseline ( a negative score being beneficial).

    12 months primary/ 18 months secondary outcome

Secondary Outcomes (3)

  • Insulin Sensitivity

    12 months

  • Speed Food Consumed

    12 months

  • Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA)

    12 months

Study Arms (2)

Mandometer

EXPERIMENTAL

Active intervention - one meal eaten per day off Mandometer

Device: MandometerBehavioral: Lifestyle

Control

ACTIVE COMPARATOR

Nutritional and activity advice alone

Device: Mandometer

Interventions

MandometerDEVICE

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.

ControlMandometer
LifestyleBEHAVIORAL

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

Mandometer

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obese children and adolescents aged 10-18

You may not qualify if:

  • Children:
  • Having associated learning difficulties
  • Who have received medication for associated insulin resistance
  • Refusal of parent/legal guardian to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Royal Hospital for Children

Bristol, BS2 8AE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 20051465RESULT

MeSH Terms

Conditions

Pediatric ObesityObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Results Point of Contact

Title
Julian Hamilton-Shield
Organization
University of Bristol
j.p.h.shield@bristol.ac.uk
00441173420183

Study Officials

  • Julian P Hamilton-Shield, MD

    University of Bristol and Bristol Royal Hospital for Children

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 5, 2006

Study Start

September 1, 2004

Primary Completion

October 1, 2009

Study Completion

January 1, 2013

Last Updated

October 9, 2019

Results First Posted

September 30, 2019

Record last verified: 2019-09

Locations

GB(1)