Extrait

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 [email protected]

Critère d'inclusion

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

Liens

• isrctn
• ictrp