A randomised controlled trial of a community-based healthy lifestyle program for overweight and obese adolescents: the Loozit® study protocol

<p>Abstract</p> <p>Background</p> <p>There is a need to develop sustainable and clinically effective weight management interventions that are suitable for delivery in community settings where the vast majority of overweight and obese adolescents should be treated. This study aims to evaluate the effect of additional therapeutic contact as an adjunct to the Loozit^®group program – a community-based, lifestyle intervention for overweight and lower grade obesity in adolescents. The additional therapeutic contact is provided via telephone coaching and either mobile phone Short Message Service or electronic mail, or both.</p> <p>Methods and design</p> <p>The study design is a two-arm randomised controlled trial that aims to recruit 168 overweight and obese 13–16 year olds (Body Mass Index z-score 1.0 to 2.5) in Sydney, Australia. Adolescents with secondary causes of obesity or significant medical illness are excluded. Participants are recruited via schools, media coverage, health professionals and several community organisations. Study arm one receives the Loozit^®group weight management program (G). Study arm two receives the same Loozit^®group weight management program plus additional therapeutic contact (G+ATC). The 'G' intervention consists of two phases. Phase 1 involves seven weekly group sessions held separately for adolescents and their parents. This is followed by phase 2 that involves a further seven group sessions held regularly, for adolescents only, until two years follow-up. Additional therapeutic contact is provided to adolescents in the 'G+ATC' study arm approximately once per fortnight during phase 2 only. Outcome measurements are assessed at 2, 12 and 24 months post-baseline and include: BMI z-score, waist z-score, metabolic profile indicators, physical activity, sedentary behaviour, eating patterns, and psychosocial well-being.</p> <p>Discussion</p> <p>The Loozit^®study is the first randomised controlled trial of a community-based adolescent weight management intervention to incorporate additional therapeutic contact via a combination of telephone coaching, mobile phone Short Message Service, and electronic mail. If shown to be successful, the Loozit^®group weight management program with additional therapeutic contact has the potential to be readily translatable to a range of health care settings.</p> <p>Trial registration</p> <p>The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRNO12606000175572).</p

Model checking of continuous-time Markov chains against timed automata specifications

We study the verification of a finite continuous-time Markov chain (CTMC) C against a linear real-time specification given as a deterministic timed automaton (DTA) A with finite or Muller acceptance conditions. The central question that we address is: what is the probability of the set of paths of C that are accepted by A, i.e., the likelihood that C satisfies A? It is shown that under finite acceptance criteria this equals the reachability probability in a finite piecewise deterministic Markov process (PDP), whereas for Muller acceptance criteria it coincides with the reachability probability of terminal strongly connected components in such a PDP. Qualitative verification is shown to amount to a graph analysis of the PDP. Reachability probabilities in our PDPs are then characterized as the least solution of a system of Volterra integral equations of the second type and are shown to be approximated by the solution of a system of partial differential equations. For single-clock DTA, this integral equation system can be transformed into a system of linear equations where the coefficients are solutions of ordinary differential equations. As the coefficients are in fact transient probabilities in CTMCs, this result implies that standard algorithms for CTMC analysis suffice to verify single-clock DTA specifications