Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial
Recio-Rodriguez, Jose I. ; Garcia-Ortiz, Luis ; Garcia-Yu, Irene A. ; Lugones-Sanchez, Cristina ; Zabaleta-del Olmo, Edurne ; Bolibar, Bonaventura ; Casajuana-Closas, Marc ; Lopez-Jimenez, Tomas ; Llobera, Joan ; Ramos, Rafel ; Pombo, Haizea ; Motrico, Emma ; Gil-Girbau, Montserrat ; Lopez-Mendez, Fatima ; Represas-Carrera, Francisco ; Maderuelo-Fernandez, Jose A.
Resumen: Background
The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).
Methods
Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45–75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor’s office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors.
Results
Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9–17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG.
Conclusions
A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice.
Trial registration
ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211
Idioma: Inglés
DOI: 10.1186/s12889-022-14590-y
Año: 2022
Publicado en: BMC PUBLIC HEALTH 22, 1 (2022), 2127 [14 pp.]
ISSN: 1471-2458
Factor impacto JCR: 4.5 (2022)
Categ. JCR: PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH rank: 66 / 207 = 0.319 (2022) - Q2 - T1
Factor impacto CITESCORE: 6.1 - Medicine (Q1)
Factor impacto SCIMAGO: 1.307 - Public Health, Environmental and Occupational Health (Q1)
Tipo y forma: Article (Published version)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
Exportado de SIDERAL (2025-10-17-14:29:11)
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The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).
Methods
Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45–75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor’s office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors.
Results
Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9–17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG.
Conclusions
A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice.
Trial registration
ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211
Idioma: Inglés
DOI: 10.1186/s12889-022-14590-y
Año: 2022
Publicado en: BMC PUBLIC HEALTH 22, 1 (2022), 2127 [14 pp.]
ISSN: 1471-2458
Factor impacto JCR: 4.5 (2022)
Categ. JCR: PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH rank: 66 / 207 = 0.319 (2022) - Q2 - T1
Factor impacto CITESCORE: 6.1 - Medicine (Q1)
Factor impacto SCIMAGO: 1.307 - Public Health, Environmental and Occupational Health (Q1)
Tipo y forma: Article (Published version)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. Exportado de SIDERAL (2025-10-17-14:29:11)
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