Changing eating behaviours to treat childhood obesity in the community using Mandolean
| ISRCTN | ISRCTN90561114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90561114 |
| Secondary identifying numbers | 11533 |
- Submission date
- 31/01/2012
- Registration date
- 31/01/2012
- Last edited
- 08/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
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 |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Changing eating behaviours to treat childhood obesity in the community using Mandolean: the ComMando (Community Mandolean) randomised trial |
| Study 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(s) | Frenchay, South West Research Ethics Committee First MREC approval date 05/12/2012, ref:11/SW/0286 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 02/04/2012 |
| Overall study end date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 640; UK Sample Size: 640 |
| Participant inclusion criteria | Obese children aged 5 - 11 years with a BMI >/= 95th percentile |
| 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
- England
- United Kingdom
Study participating centre
BS8 2PS
United Kingdom
Sponsor information
University/education
Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No |
