Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial.

BACKGROUND: Physical exercise interventions have been extensively advocated for the treatment of obesity; however, clinical trials evaluating the effectiveness of exercise interventions on weight control show controversial results. Compensatory mechanisms through a decrease in energy expenditure and/or an increase in caloric consumption is a possible explanation. Several physiological mechanisms involved in the energy balance could explain compensatory mechanisms, but the influences of physical exercise on these adjustments are still unclear. Therefore, the present trial aims to evaluate the effects of exercise on non-exercise physical activity energy expenditure, energy intake and appetite sensations among active overweight/obese adults, as well as, to investigate hormonal changes associated with physical exercise.

METHODS: This study is a randomized controlled trial with parallel, three-group experimental arms. Eighty-one overweight/obese adults will be randomly allocated (1:1:1 ratio) to a vigorous exercise group, moderate exercise group or control group. The trial will be conducted at a military institution and the intervention groups will be submitted to exercise sessions in the evening, three times a week for 65 min, during a 2-week period. The primary outcome will be total spontaneous physical activity energy expenditure during a 2-week period. Secondary outcomes will be caloric intake, appetite sensations and laboratorial biomarkers. Intention-to-treat analysis will be performed using linear mixed-effects models to evaluate the effect of treatment-by-time interaction on primary and secondary outcomes. Data analysis will be performed using SAS 9.3 and statistical significance will be set at p < 0.05.

DISCUSSION: The results of the present study will help to understand the effect of physical exercise training on subsequent non-exercise physical activity, appetite and energy intake as well as understand the physiological mechanisms underlying a possible compensatory phenomenon, supporting the development of more effective interventions for prevention and treatment of obesity.

TRIAL REGISTRATION: Physical Exercise and Energy Balance trial registry, trial registration number: NCT 03138187 . Registered on 30 April 2017.