Extrait

Background and study aims Obesity is a key economic and healthcare challenge for Europe. Most adults try to lose weight but fail to maintain it. Effective programmes for weight loss are widely available, but most people re-gain their lost weight. The most promising behaviour change techniques for maintaining weight loss maintenance are self-monitoring, goal setting, action control, building self-efficacy and intrinsic motivation. Stress management and emotion regulation skills can also prevent relapse and weight regain. Information communication technology (ICT) offers attractive tools for teaching and supporting these techniques, some of which are currently delivered face-to-face. ICT delivery includes tracking technologies, weighing scales and activity sensors, online tools and smartphone apps, multimedia resources and internet-based support. A broad choice of tools is most likely to be acceptable to users, who can pick and choose their own preferred technologies. This study tests whether ICT-based delivery of the most promising behavior change techniques is effective for maintaining weight loss. Who can participate? Adults aged 18 or older who have lost at least 5% of their body weight intentionally in the last 12 months, and started with a BMI of 25 or more What does the study involve? Participants are invited to attend five sessions across 18 months. Additionally, at a number of time points (month 1, 3, 6, 12 and 18) throughout the study, participants are also asked to complete some short online questionnaires about their experience of the toolkit. The first visit takes place at the research centre at the University of Leeds and takes up to 4 hours. Participants are asked to give a range of measurements including body weight, height, hip and waist circumference, and health markers including optional blood pressure, body composition, and optional hair samples. Participants also have the option to provide fasting blood samples via a small finger-prick, which will help to assess important health markers but this is voluntary. Participants are also asked to fill out a one-off questionnaire. This includes information such as date of birth, gender, and personal characteristics (e.g. weight loss history, experience with mobile technologies, and some questions about your typical eating behaviour). Participants are also asked to complete questionnaires relating to physical activity, motivation, emotional state, stress, well-being, quality of life, and diet. Participants are then randomly allocated to one of four groups. These groups are offered one of four different versions of the toolkit that might provide general health information, tools to help participants self-manage their eating and activity behaviours, their motivation, or their emotional responses to stress. Participants in each of these groups are required to weigh themselves a minimum of twice a week and on the same days of the week (e.g., Monday and Thursday) throughout the study with the Fitbit Aria weighing scales. Participants are also required to wear a wrist-worn activity meter (Fitbit Charge 2) for the duration of the study. Participants are provided with these devices free of charge. At the end of the day, there is a short training session to get participants set up with their tools (Fitbit Charge 2 and Aria weighing scales). A few days after their visit participants are also asked to complete an online 4-day food diary. Participants are then asked to visit the University of Leeds one week later for a shorter second visit (2 hours) for training on how to use the different components of the Toolkit (i.e. the NoHoW web-based app, the Fitbit Charge 2 and Aria scales). The third, fourth and fifth visits take place at 6, 12 and 18 months after the first visit and last up to 4 hours each. A researcher takes many of the same measurements made at visit 1 including body weight, height, hip and waist circumference, blood pressure and body composition. Participants are asked to complete questionnaires relating to physical activity, motivation, emotional state, stress, well-being, quality of life, and diet. What are the possible benefits and risks of participating? The potential benefits are increased knowledge and skills for weight loss maintenance in the long-term. Participants receive a £30 reward and are able to keep the Fitbit Charge HR and Aria scales for free. There are no expected disadvantages involved in taking part in this study. Where is the study run from? 1. University of Leeds (UK) 2. The Parker Institute (Denmark) 3. University of Lisbon (Portugal) When is the study starting and how long is it expected to run for? March 2015 to February 2020 Who is funding the study? European Union’s Horizon 2020 research and innovation programme (Belgium) Who is the main contact? Prof. James Stubbs [email protected]

Critère d'inclusion

• Overweight and obese adults who have achieved clinically significant weight loss (5%)

Liens

• isrctn