Evidence map›Paper›PMID 33284131›Full record

Trial reportJournal of medical Internet research2020

A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial.

Leticia Goni, Víctor de la O, M Teresa Barrio-López, Pablo Ramos, Luis Tercedor, Jose Luis Ibañez-Criado, Eduardo Castellanos, Alicia Ibañez Criado, Rosa Macias Ruiz, Ignacio García-Bolao and 3 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
0.5field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03053843 naunknown statusnot on this map

Randomized Trial of Mediterranean Diet Plus Extravirgin Olive Oil in the Prevention of Recurrent Arrhythmias. The PREDIMAR (PREvención Con DIeta Mediterránea de Arritmias Recurrentes) Trial

TypeinterventionalSponsorFundación de investigación HMRan2017 to 2022Enrolled720ConditionsAtrial Fibrillation, Atrial ArrhythmiaArmsMediterranean diet plus extra virgin olive oil
NCT06257641 nacompletednot on this mapstarted 2024, after this paper: background citation

Impact of the Mediterranean Diet on Patients with Psoriasis: a Randomized Clinical Trial

TypeinterventionalSponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalRan2024 to 2025Enrolled38ConditionsPsoriasis, Psoriasis Vulgaris, Hyperlipidemias, DepressionArmsHigh-intensity Mediterranean diet intervention
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Dietary interventions in the management of atrial fibrillation.Frontiers in cardiovascular medicine · 2024
    Pooled it
  3. Digital behaviour change interventions to increase vegetable intake in adults: a systematic review.The international journal of behavioral nutrition and physical activity · 2023
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

Leticia GoniDepartment of Preventive Medicine and Public Health, University of Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.ORCID 0000-0002-5479-2045
Víctor de la ODepartment of Preventive Medicine and Public Health, University of Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.ORCID 0000-0002-9916-275X
M Teresa Barrio-LópezElectrophysiology Laboratory and Arrhythmia Unit, Hospital Montepríncipe, Grupo HM Hospitales, University CEU-San Pablo, Madrid, Spain.ORCID 0000-0002-8001-9398
Pablo RamosArrhythmia Unit, Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra, Pamplona, Spain.ORCID 0000-0001-9777-4333
Luis TercedorDepartment of Cardiology, Virgen de las Nieves University Hospital, Granada, Spain.ORCID 0000-0002-9566-8809
Jose Luis Ibañez-CriadoArrhythmia Unit, Cardiology Service, Alicante Institute of Health and Biomedical Research (ISABIAL-FISABIO Foundation), University General Hospital of Alicante, Alicante, Spain.ORCID 0000-0003-0792-6669
Eduardo CastellanosElectrophysiology Laboratory and Arrhythmia Unit, Hospital Montepríncipe, Grupo HM Hospitales, University CEU-San Pablo, Madrid, Spain.ORCID 0000-0002-5081-8252
Alicia Ibañez CriadoArrhythmia Unit, Cardiology Service, Alicante Institute of Health and Biomedical Research (ISABIAL-FISABIO Foundation), University General Hospital of Alicante, Alicante, Spain.ORCID 0000-0001-7352-6597
Rosa Macias RuizDepartment of Cardiology, Virgen de las Nieves University Hospital, Granada, Spain.ORCID 0000-0003-4686-5678
Ignacio García-BolaoArrhythmia Unit, Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra, Pamplona, Spain.ORCID 0000-0002-8544-7324
Jesus AlmendralElectrophysiology Laboratory and Arrhythmia Unit, Hospital Montepríncipe, Grupo HM Hospitales, University CEU-San Pablo, Madrid, Spain.ORCID 0000-0001-6223-0862
Miguel Ángel Martínez-GonzálezDepartment of Preventive Medicine and Public Health, University of Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.ORCID 0000-0002-3917-9808
Miguel Ruiz-CanelaDepartment of Preventive Medicine and Public Health, University of Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.ORCID 0000-0002-7684-2787
HM Hospitales · ESClinica Universidad de Navarra · ESFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESInstituto de Salud Carlos III · ESHarvard University · USHospital Universitario Virgen de las Nieves · ESInstituto de Investigación Biosanitaria de Granada · ESNavarre Institute of Health Research · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Prevention With Mediterranean Diet (PREDIMED) trial supported the effectiveness of a nutritional intervention conducted by a dietitian to prevent cardiovascular disease. However, the effect of a remote intervention to follow the Mediterranean diet has been less explored.

objectiveThis study aims to assess the effectiveness of a remotely provided Mediterranean diet-based nutritional intervention in obtaining favorable dietary changes in the context of a secondary prevention trial of atrial fibrillation (AF).

methodsThe PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study is a 2-year multicenter, randomized, controlled, single-blinded trial to assess the effect of the Mediterranean diet enriched with extra virgin olive oil (EVOO) on the prevention of atrial tachyarrhythmia recurrence after catheter ablation. Participants in sinus rhythm after ablation were randomly assigned to an intervention group (Mediterranean diet enriched with EVOO) or a control group (usual clinical care). The remote nutritional intervention included phone contacts (1 per 3 months) and web-based interventions with provision of dietary recommendations, and participants had access to a web page, a mobile app, and printed resources. The information is divided into 6 areas: Recommended foods, Menus, News and Online resources, Practical tips, Mediterranean diet classroom, and Your personal experience. At baseline and at 1-year and 2-year follow-up, the 14-item Mediterranean Diet Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire were collected by a dietitian by phone.

resultsA total of 720 subjects were randomized (365 to the intervention group, 355 to the control group). Up to September 2020, 560 subjects completed the first year (560/574, retention rate 95.6%) and 304 completed the second year (304/322, retention rate 94.4%) of the intervention. After 24 months of follow-up, increased adherence to the Mediterranean diet was observed in both groups, but the improvement was significantly higher in the intervention group than in the control group (net between-group difference: 1.8 points in the MEDAS questionnaire (95% CI 1.4-2.2; P<.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (P<.001), olive oil (P<.001), whole grain cereals (P=.002), pulses (P<.001), nuts (P<.001), white fish (P<.001), fatty fish (P<.001), and white meat (P=.007), and a significant reduction in refined cereals (P<.001), red and processed meat (P<.001), and sweets (P<.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (P<.001) and fiber (P<.001), and they decreased their intake of carbohydrates (P=.02) and saturated fatty acids (P<.001) compared with the control group.

conclusionsThe remote nutritional intervention using a website and phone calls seems to be effective in increasing adherence to the Mediterranean diet pattern among AF patients treated with catheter ablation.

trial registrationClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843.

Indexed as

Atrial FibrillationDiet, MediterraneanFeeding BehaviorFemaleHumansMaleNutrition AssessmentRisk FactorsSecondary Preventionatrial fibrillationMediterranean dietolive oilremote interventionsecondary prevention

Identifiers

PMID33284131
PMCPMC7752535
OpenAlexW3111130556

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.