Women's Involvement in Steady Exercise (WISE): Study Protocol for a Randomized Controlled Trial

Background: Physical inactivity is a serious public health problem for people of all ages and is currently the fourth highest global risk factor for mortality. The transition period from adolescence to adulthood coincides with a marked reduction in participation in physical activity, with more than 50% (and up to 80%) of young adults stopping physical activity. This decrease in physical activity is more evident in women than in men. Despite efforts, existing programs face challenges in effectively initiating and maintaining physical activity among individuals, particularly women, for extended durations. To address these limitations, the Women's Involvement in Steady Exercise (WISE) randomized controlled trial (RCT) seeks to assess the efficacy of a digital high-intensity training intervention complemented by nutritional plans and other health-related advice.

Methods: The study will be a three-center, randomized (1:1), controlled, parallel-group trial with a six-month intervention period. A total of 300 participants will be recruited at three study sites in Spain, Serbia and Italy. The participants will be randomized to one of the two groups and will follow a six-month program. The primary outcome of the study is the daily step count. Self-reported physical activity, the adherence to the exercise program, body composition, physical activity enjoyment, quality of sleep and physical capacities will also be evaluated.