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
Mrs Gwen Brierley
Academic Unit of Primary Health Care
School of Social and Community Medicine
39 Whatley Road
Changing eating behaviours to treat childhood obesity in the community using Mandolean: the ComMando (Community Mandolean) randomised trial
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
Frenchay, South West Research Ethics Committee First MREC approval date 05/12/2012, ref:11/SW/0286
Randomised; Interventional; Design type: Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
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
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
Overall trial end date
Participant inclusion criteria
Obese children aged 5 - 11 years with a BMI >/= 95th percentile
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
Recruitment end date
Countries of recruitment
Trial participating centre
University of Bristol
Health Technology Assessment Programme
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
Funding Body Subtype
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25043221
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.