Innovative population-based strategies for primary prevention of cardiovascular disease: A 2-year randomised control trial (RCT) evaluating behavioral change led by community cham-pions versus brief advice.

Delphine Le Goff, Gabriel Perraud, Jérémy Derriennic, Paul Aujoulat, Morgane Guillou, Marie Barais, Jean Yves Le Reste

Keywords: primary prevention; cardiovascular system; community participation; community health workers; motivational interviewing

Background:

Cardiovascular diseases (CVD) cause 17,9 million deaths worldwide. The SPICES project implemented a cardiovascular disease prevention community-based program. During the summer 2019, students screened the population with the Interheart Non-Laboratory Score (INL) to recruit participants in a French rural and vulnerable setting. Then, community champions were trained to behavioural change. The aim of this study was to assess their efficacy with intermediate INL adults.

Research questions:

The primary objective of this study was to evaluate the efficacy of a behavioural change program plus brief advice, conducted by community champions, for people at intermediate cardiovascular risk, compared with brief advice only.

Method:

A randomised control trial with 1:1 allocation tested brief advice plus behavioral change led by community champions versus brief advice. A 24-month difference of 15% in the INL in intention to treat was expected. Participants objectives were independently recorded at 4 months.

Results:

1309 participants were includable. 536 people were analyzed. In March 2021, happened the Covid 19 pandemic with three lockdowns during the trial and public restrictions. At 24 months, 110 people remained in intervention group and 147 in control group (total=257). Difference within groups was not significant (-0,12 (-0,80; 1,04) p=0,758). The main participants objective was weight-loss. In accordance with the hierarchical analysis, the confirmatory analysis procedure could not continue beyond the first non-significant criterion. On an exploratory basis, no significant difference was found on the secondary criteria. Only 29% of eligible subjects agreed to participate to the study. Among those, only 48% completed the study.

Conclusions:

The difference of the mean INL score of 15% was not achieved. Money for health procedures would better be invested in public procedures. People entering individual strategies should be sorted on their capacities to change. The investment to accompany participants did not lead to success despite the sociological literature evidence.

Points for discussion:

efficiency of community support

efficiency of self-set goals

scores accuracy