The additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.
PROACTIVE-19 is a pragmatic, randomized controlled clinical trial with adaptive "sample size
re-estimation" design. Volunteers will be randomized into two groups: (A) generalized health
education; (B) personalized health education. Participants will go through phone questioning
and recommendation in 5 fields: (1) mental health (2) smoking habits, (3) physical activity,
(4) dietary habits, (5) alcohol consumption. Both groups A and B will receive the same line
of questioning to assess habits concerning these topics. In Group A: questioning will be done
in sequence followed by a shared minimal intervention aimed towards improvement of these
factors but without any personalized recommendation. In Group B: each assessment will be
followed by specific and personalized recommendations. Assessment will be done weekly during
the first month, every second week in the second month, then monthly. Considering one interim
analysis for efficacy the estimated sample size is 3788 (rounded up to 3800) subject per
study arm. The planned duration of the follow up is a minimum of one year.
Behavioral: Personalized health education
Subjects will go through questioning and recommendations in 5 domains: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits and (5) alcohol consumption. Then they will receive detailed individualized education regarding lifestyle changes based on their current habits.
Behavioral: General health education
Subjects will go through questioning and recommendations in 5 domains: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits and (5) alcohol consumption. Then they will receive general health education aiming towards improvement of these factors with general recommendations following the WHO principles.
The inclusion criteria are:
1. age over 60 years;
2. informed consent to participate.
The exclusion criteria are:
1. confirmed COVID-19 infection (active or recovered);
2. hospitalization at screening for eligibility;
3. someone was already enrolled in the study from the same community/household (to avoid
potential crosstalk between the study arms).
Institute for Translational Medicine, University of Pécs
Pécs, Hungary
Péter Hegyi, MD, PhD, DSc, Study Chair
Insitute for Translational Medicine, University of Pécs, HU