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

BACKGROUND

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.

METHODS AND DESIGN

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.

DISCUSSION

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.

TRIAL REGISTRATION

The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRNO12606000175572).