The diet and exercise motivation study-demos: diet and physical exercise with remote psychological motivation to improve fitness and cardio-metabolic parameters in primary cardiovascular prevention subjects at heightened risk.

Background: Lifestyle changes are likely to be the most effective measures for the prevention of cardiovascular disease. Combined with pharmacological therapies, diet and physical exercise are important correlates of protection against cardiovascular events, thus being proposed and prescribed as the ideal risk-reduction strategy for both primary and secondary prevention programs. However, the lack of individual motivation is a main limitation to the feasibility and efficacy of current recommendations in terms of cardiovascular prevention and maintenance of benefits over time. Methods: In a prospective, randomized, open-label study (Diet, Exercise and Motivation Study – DEMOS), we evaluated the effectiveness of a lifestyle improvement strategy in individuals at heightened cardiovascular risk in a primary prevention setting. The primary study endpoint of Phase 1 of DEMOS was the documentation of a significantly greater improvement in physical performance, based on the increase in maximum oxygen consumption (peak VO2), in an intensive vs standard treatment group. The final primary endpoint of the study, still ongoing, will be the documentation of better maintenance of improvements achieved in Phase 1, through a psychological motivation strategy based on remote smartphone messaging. Additional endpoints are the documentation of improvements in cardio-metabolic parameters, as well as the maintenance of benefits over time, subjects’ acceptance, and cost-effectiveness of the motivational support, on trends of cardiovascular health parameters in the active treatment compared with the control group. All subjects also underwent a basal CT scan for coronary calcium evaluation and repeated cardiopulmonary exercise test (CPET) for peak VO2 calculation. We here report on the changes in physical performance parameters in the initial “acute” phase 1 of the study. Results: After a run-in phase of 2 months, 60 male subjects aged between 40 and 60 years were randomly assigned to an intensive or a standard treatment in a 1: 1 ratio. At baseline, there was no significant difference between the two groups in peak VO2 values (p ¼ 0.953). After 3 months, there was still no significant between groups difference in the occurrence of the primary endpoint (p ¼ 0.201). However, the subgroup of patients with good adherence to the intensive treatment (>75% of the scheduled activity) showed a significant increase of peak VO2 compared to less compliant individuals. The overall adherence to the protocol was significantly higher in the intensive treatment group with motivational support. Conclusions: An intensive lifestyle intervention in subjects at moderate cardiovascular risk is not superior to standard treatment in terms of physical performance improvement at 3 months, unless an important adherence to the intensive protocol is assured. Patient compliance is likely to be a major determinant of treatment response, and a psychological motivation of subjects enrolled in such complex protocols of global lifestyle changes is likely to be key for the protocol success.