Evidence map›Paper›PMID 31613346›Full record

Trial reportJAMA2019

Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial.

Carmen Sayón-Orea, Cristina Razquin, Mónica Bulló, Dolores Corella, Montserrat Fitó, Dora Romaguera, Jesús Vioque, Ángel M Alonso-Gómez, Julia Wärnberg, J Alfredo Martínez and 41 more

2 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA, 2019. 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 85 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT05282316 nacompletednot on this mapstarted 2022, after this paper: background citation

Impact of Extra Virgin Olive Oil (EVOO) with Health Properties in Improving the Overall Health Status and Preventing Cardiovascular Risk in Metabolic Syndrome

TypeinterventionalSponsorUniversity of PalermoRan2022 to 2024Enrolled90ConditionsMetabolic SyndromeArmsEVOO polyphenols enriched, EVOO standard
NCT05394779 nacompletednot on this mapstarted 2022, after this paper: background citation

Evaluation of Performance and Safety of DTXO App, an Innovative Digital Therapy, in Improving Weight Loss and Weight-Loss Maintenance of Patients With Obesity by Increasing Their Adherence to Dietary, Exercise Regimens and Psycho-Behavioral Program

TypeinterventionalSponsorAdvice Pharma Group srlRan2022 to 2024Enrolled246ConditionsObesity, Health Behavior, Life Style, Dietary HabitsArmsDTXO APP, PLACEBO APP - Control group
3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Mediterranean Diet and its Benefits on Health and Mental Health: A Literature Review.Clinical practice and epidemiology in mental health : CP & EMH · 2020
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

51 authors.

Carmen Sayón-OreaCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Cristina RazquinCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Mónica BullóCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Dolores CorellaCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Montserrat FitóCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Dora RomagueraCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Jesús VioqueCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Ángel M Alonso-GómezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Julia WärnbergCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
J Alfredo MartínezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Luís Serra-MajemCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Ramón EstruchCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Francisco J TinahonesCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
José LapetraCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Xavier PintóCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Josep A TurCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
José López-MirandaCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Aurora Bueno-CavanillasCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Miguel Delgado-RodríguezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Pilar Matía-MartínCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Lidia DaimielCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Vicente Martín SánchezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Josep VidalCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Clotilde VázquezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Emilio RosCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Miguel Ruiz-CanelaCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
José V SorlíCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Olga CastañerCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Miquel FiolCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Eva M Navarrete-MuñozCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Fernando ArósCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Enrique Gómez-GraciaCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
M Angeles ZuletCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Almudena Sánchez-Villegas
Rosa CasasCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Rosa Bernal-LópezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
José M Santos-LozanoCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Emili CorbellaCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Cristina BouzasCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Ana García-ArellanoCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Josep BasoraCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Eva M AsensioCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Helmut SchröderCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Manuel MoñinoCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Manoli García de la HeraCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Lucas Tojal-SierraCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Estefanía ToledoCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Andrés Díaz-LópezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Albert GodayCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Jordi Salas-SalvadóCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.
Miguel A Martínez-GonzálezCentro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III, Madrid, Spain.

Funding

European Research Council
6 · The paper itself

Abstract

Importance: High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. Objective: To assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and Participants: Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. Interventions: Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. Main Outcomes and Measures: The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). Results: Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). Conclusions and Relevance: In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed. Trial Registration: isrctn.com Identifier: ISRCTN89898870.

Indexed as

Caloric RestrictionDiet, MediterraneanExercisePatient ComplianceAgedCardiovascular DiseasesDiet SurveysFemaleHealth EducationHumansLinear ModelsLipidsMaleMetabolic SyndromeMiddle AgedObesityLipids

Identifiers

PMID31613346
PMCPMC6802271

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.