Twelve-month outcomes of the loozit randomized controlled trial: a community-based healthy lifestyle program for overweight and obese adolescents.

Objectives: To assess the outcomes of the Loozit adolescent weight management intervention and to evaluate the effect of additional therapeutic contact 12 months into the program.

Design: A 24-month, 2-arm randomized controlled trial. Results at 12 months are presented.

Setting: Community health center and children's hospital in Sydney, Australia.

Participants: A total of 151 overweight or obese 13- to 16-year-olds.

Intervention: In the first 2 months (phase 1), participants received 7 adolescent and parent weekly sessions focused on lifestyle modification. From 2 to 24 months (phase 2), adolescents attended booster sessions once every 3 months. During phase 2, adolescents randomized to the additional therapeutic contact arm also received telephone coaching and electronic communications once every 2 weeks.

Outcome Measures: Baseline to 12-month changes in body mass index z score and waist to height ratio (primary outcomes) and changes in metabolic, psychosocial, and behavioral variables.

Results: Of 151 randomized adolescents, 82.1% completed 12-month follow-up. Intent-to-treat analyses showed significant reductions in mean body mass index z score (-0.09; 95% CI, -0.12 to -0.06), waist to height ratio (-0.02; 95% CI, -0.03 to -0.01), total cholesterol level (-4 mg/dL; 95% CI, -8 to 0 mg/dL; to convert to millimoles per liter, multiply by 0.0259), and triglycerides level (geometric mean, -80 mg/dL; 95% CI, -88 to -71 mg/dL; to convert to millimoles per liter, multiply by 0.0113). Most psychosocial outcomes improved, including global self-worth, but there were few dietary, physical activity, or sedentary behavior changes. No difference was found in primary outcomes between participants who did or did not receive additional therapeutic contact.

Conclusions: The Loozit randomized controlled trial produced a significant but modest reduction in body mass index z score and improved psychosocial outcomes at 12 months. Supplementary telephone and electronic contact provided no additional benefit at 12 months. Trial Registration anzctr.org.au Identifier: 12606000175572.