Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/01/2012
Date assigned
31/01/2012
Last edited
08/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obesity is the most common disorder of childhood and adolescence. Childhood obesity can have immediate health consequences, including diabetes, a worsening of asthma, and liver disease., Obesity often continues into adulthood, leading to long-term health problems such as heart disease and cancer. Evidence on treatments for childhood obesity is limited. Most treatments designed to promote weight loss in children have so far been unsuccessful. Recently, a new device, the Mandolean, was found to help with weight loss in adolescents when used with a weight management programme. The Mandolean is a weighing scale which measures the user’s rate of eating and satiety (fullness) and provides feedback to help change eating behaviours. This study aims to establish the clinical and cost-effectiveness of the addition of Mandolean to a weight management programme for children aged 5-11 years.

Who can participate?
Obese children aged 5 – 11 and their parents.

What does the study involve?
Participants are randomly allocated to receive either a weight management programme alone or a weight management programme plus the Mandolean device. Body mass index (BMI), rate of eating, satiety ratings and overall health will be measured at the start of the study. Participants will have five appointments over a year with a nurse who will promote lifestyle changes to aid weight loss. Those who receive the Mandolean will be asked to eat one meal a day using the Mandolean for one year. At 1 and 2 years after entering the study we will find out if there are any differences between the groups and whether these are maintained after treatment has ended.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University of Bristol (UK).

When is the study starting and how long is it expected to run for?
April 2012 to December 2014.

Who is funding the study?
Health Technology Assessment Programme (UK).

Who is the main contact?
Mrs Gwen Brierley
gwen.brierley@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Gwen Brierley

ORCID ID

Contact details

Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
-
gwen.brierley@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11533

Study information

Scientific title

Changing eating behaviours to treat childhood obesity in the community using Mandolean: the ComMando (Community Mandolean) randomised trial

Acronym

ComMando

Study hypothesis

To establish the clinical and cost effectiveness of the addition of Mandolean treatment to a primary care weight management programme for obese children over a 12 and 24 month follow-up period

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11533

Ethics approval

Frenchay, South West Research Ethics Committee First MREC approval date 05/12/2012, ref:11/SW/0286

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

640 parent-child pairs will be randomised on a 1:1 ratio to either the control (weight managment programme alone) or intervention (weight management programme plus Mandolean) arm.

1. Control arm: Weight management programme delivered in Primary Care.
2. Intervention arm: Weight management programme delivered in primary care plus training and use of Mandolean at home for 1 year.

Follow Up Length: 24 month(s); Study Entry : Single Randomisation only

Intervention type

Device

Phase

Drug names

Primary outcome measures

Child BMI standard deviation scores (SDS); Timepoint(s): 12 months

Secondary outcome measures

1. Adult eating rate; Timepoint(s): 12 & 24 months
2. Child BMI SDS; Timepoint(s): 24 months
3. Child eating rate; Timepoint(s): 12 & 24 months
4. Child ideal portion size choice; Timepoint(s): 12 & 24 months
5. Child self determined portion size; Timepoint(s): 12 & 24 months
6. Child Health Utility Index 9D (CHU9D); Timepoint(s): 3, 6, 9, 12 & 24 months
7. EQ5D; Timepoint(s): 3, 6, 9, 12 & 24 months
8. EQ5D-Y; Timepoint(s): 3, 6, 9, 12 & 24 months
9. Parent BMI; Timepoint(s): 12 & 24 months
10. Parent ideal portion size choice; Timepoint(s): 12 and 24 months
11. Parent self determined portion size; Timepoint(s): 12 and 24 months
12. PedsQL; Timepoint(s): 12 & 24 months

Overall trial start date

02/04/2012

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Obese children aged 5 - 11 years with a BMI >/= 95th percentile

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 640; UK Sample Size: 640

Participant exclusion criteria

Children whose weight management requires secondary care consultation as the intervention under investigation is focused on management in primary care. Exclusion criteria will be identified by the referring GP using a standardised checklist.

Recruitment start date

02/04/2012

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25043221

Publication citations

  1. Results

    Hamilton-Shield J, Goodred J, Powell L, Thorn J, Banks J, Hollinghurst S, Montgomery A, Turner K, Sharp D, Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando)--a pilot study., Health Technol Assess, 2014, 18, 47, i-xxiii, 1-75, doi: 10.3310/hta18470.

Additional files

Editorial Notes