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SUPPLEMENTARY DATA

2018 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc18-0836/-/DC1

The set of data, tables and figure has been provided by the authors to give readers additional information about

their work. For this reason, we would like this file of supplemental material to be included with our paper, in case

of acceptance, as online-only supplemental material.

Table of Contents

1. List of PREDIMED-Plus study Investigators.

2. Trial enrolment criteria.

3. 17-item questionnaire to assess adherence to the energy-restricted Mediterranean diet used in the

intervention arm of the PREDIMED-PLUS trial.

4. 14-item questionnaire to assess adherence to the non-energy restricted Mediterranean diet (in the control

group) of the PREDIMED-PLUS study.

5. Objectives in terms of weight loss, energy-restricted Mediterranean dietary intervention and intensive

physical activity and behavioral program in the PREDIMED-Plus intervention group.

6. Intervention in the PREDIMED-Plus control group.

7. Anthropometric, body composition and blood pressure measurements.

8. Biochemical measurements.

9. Supplementary Figure S1. Study flow diagram

10. Supplementary Table S1. Proportion of participants (%) achieving the goal at baseline and changes in

the percentage of participants achieving the goal for each of the 17-item of the Mediterranean diet score at 6-

and 12-months of intervention by treatment group (completers-only).

11. Supplementary Table S2. Baseline and 6- and 12-month changes in 17-point Mediterranean diet score,

energy expenditure in leisure-time physical activity, 30-s chair-stand test and sedentary behaviors by

treatment group.

12. Supplementary Table S3. Baseline and 6- and 12-month changes in the consumption of key food items

by treatment group (completers-only).

13. Supplementary Table S4. Baseline and 6-and 12-month changes in energy and nutrient intake by

treatment group (completers-only).

14. Supplementary Table S5. Mean body weight loss (kg) at 6- and 12-months in specific subgroups by

treatment group (completers-only).

15. Supplementary Table S6. Baseline and 12-month changes in lean and fat mass by treatment group in a

subset of participants with body composition data (completers-only).

16. Supplementary Table S7. Baseline and 6- and 12-month changes in glucose metabolism-related

parameters and lipid profile by treatment group for participants with normal glycemia: intention-to-treat

(multiple imputation, MI) and completers-only.

17. Supplementary Table S8. Baseline and 6- and 12-month changes in glucose metabolism-related

parameters and lipid profile by treatment group for participants with prediabetes: intention-to-treat (multiple

imputation, MI) and completers-only.

18. Supplementary Table S9. Baseline and 6- and 12-month changes in glucose metabolism-related

parameters and lipid profile by treatment group for participants with diabetes: intention-to-treat (multiple

imputation, MI) and completers-only.

19. Supplementary Table S10. Proportion of participants (%) using drugs at baseline and changes during the

intervention by treatment group (completers-only).

20. Supplementary Table S11. Baseline and 12-month changes in cardiovascular risk biomarkers by

treatment group (completers-only).

21. References.

SUPPLEMENTARY DATA

2018 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc18-0836/-/DC1

1. List of PREDIMED-Plus study investigators

Steering Committee:

J. Salas-Salvad (Coordinator), M.A. Martnez-Gonzlez (PI ERC Grant), M. Fit. E. Ros, FJ. Tinahones, D.

Corella and R. Estruch.

Executive Committee: J. Salas-Salvad, M.A. Martnez-Gonzlez, D. Corella, M. Fit, J. Vioque, D. Romaguera, J.A Martnez, J.

Wrnberg, J. Lopez-Miranda, R. Estruch, A. Bueno-Cavanillas, F. Ars, J.A. Tur, FJ. Tinahones, L. Serra-Majem,

V. Martin, J. Lapetra, C. Vzquez, X. Pinto, J. Vidal, L. Daimiel, M. Delgado-Rodrguez, M.A. Rubio and E. Ros.

Dietary and Lifestyle Intervention Committee: J. Salas-Salvad (chair), M.A. Martnez-Gonzlez, M. Fit and R. Estruch;

Dietary Intervention: J. Salas-Salvad (chair), N. Babio, E. Ros, A. Snchez-Tainta;

Physical Exercise: M. Fit (chair), H. Schrder, A. Marcos, D. Corella, J. Warnberg;

Behavioural support: R. Estruch (chair), F. Fernndez-Aranda, C. Botella and J. Salas-Salvad.

Clinical Event Ascertainment Committee: F. Ars (chair), M. Aldamiz, A. Alonso, J. Berjn, L. Forga, J. Gllego, M.A. Garca Layana, A. Larrauri, J.

Portu, J. Timiraos, M. Serrano-Martnez.

Independent Data and Safety Monitoring Board: M.J. Stampfer (Harvard School of Public Health), J. Sabate (Loma Linda University), A. Astrup (Copenhagen

University), F. Fernandez-Aviles (Universidad Complutense of Madrid), X. Pi-Sunyer (Columbia University).

Department of Preventive Medicine and Public Health, University of Navarra-Navarra Institute for Health

Research (IdiSNA), Pamplona, Spain: M. Ruiz-Canela, E. Toledo, P. Buil-Cosiales, C. Razquin, M. Bes-

Rastrollo, A. Sanchez Tainta, B. SanJulian Aranguren, E. Goi, I. Barrientos, M. Canales, A. Rico, J. Basterra

Gortari, A. Garcia Arellano, J. Diez-Espino, O. Lecea-Juarez, J. Carlos Cenoz-Osinaga, J. Bartolome-Resano, A.

Sola-Larraza, E. Lozano-Oloriz, B. Cano-Valles, S. Eguaras, E. Pascual Roquet-Jalmar, I. Galilea-Zabalza, H.

Lancova, R. Ramallal, M.L. Garcia-Perez, V. Estremera-Urabayen, M.J. Ariz-Arnedo, C. Hijos-Larraz, C.

Fernandez Alfaro, B. Iigo-Martinez, R. Villanueva Moreno, S. Martin-Almendros, L. Barandiaran-Bengoetxea,

C. Fuertes-Goi, A. Lezaun-Indurain, M.J. Guruchaga-Arcelus, O. Olmedo-Cruz, B. Iigo-Martnez, L. Escriche-

Erviti, R. Ansorena-Ros, R. Sanmatin-Zabaleta, J. Apalategi-Lasa, J. Villanueva-Telleria, M.M. Hernndez-

Espinosa, I. Arroyo-Bergera, L. Herrera-Valdez, L. Dorronsoro-Dorronsoro, Z. Vzquez.

Department of Preventive Medicine, University of Valencia, University Jaume I, Conselleria de Sanitat de

la Generalitat Valenciana, Valencia, Spain: J.I. Gonzlez, J.V. Sorl, O. Portols, R. Fernndez-Carrin, C.

Ortega-Azorn, R. Barragn, E.M. Asensio, O. Coltell, C. Siz, R. Osma, E. Frriz, I. Gonzlez-Monje, F.

Gimnez-Fernndez, L. Quiles, P. Carrasco, N. San Onofre, A. Carratal-Calvo, C. Valero-Barcel, F. Antn, C.

Mir, S. Snchez-Navarro, J. Navas, I. Gonzlez-Gallego, L. Bort-Llorca, L. Prez-Ollero, M. Giner-Valero, R.

Monfort-Sez, J. Nadal-Sayol, V. Pascual-Fuster, M. Martnez-Prez, C. Riera, M.V. Belda, A. Medina, E.

Miralles, M.J. Ramrez-Esplugues, M. Rojo-Furi, G. Mattingley, M.A. Delgado, M.A. Pages, Y. Riofro, L.

Abuomar, N. Blasco-Lafarga, R. Tosca, L. Lizn, A.M. Valcarce, M.D. Medina, R. Monfort, S. de Valcrcel, N.

Tormo, O. Felipe-Romn, S. Lafuente, E.I. Navo, G. Aldana, J.V. Crespo, J.L. Llosa, L. Gonzlez-Garca, R.

Raga-Mar.

Rovira i Virgili University, Department of Biochemistry and Biotechnology, Human Nutrition Unit,

University Hospital of Sant Joan de Reus, Pere Virgili Institute for Health Research, Reus, Spain: R. Pedret

Llaberia, R. Gonzalez, R. Sagarra lamo, F. Pars Palleja, J. Balsells, J.M. Roca, T. Basora Gallisa, J. Vizcaino,

P. Llobet Alpizarte, C. Anguera Perpi, M. Llaurad Vernet, C. Caballero, M. Garcia Barco, M.D. Morn

Martnez, J. Garca Rossell, A. Del Pozo, C. Poblet Calaf, P. Arcelin Zabal, X. Floresv, M. Ciutat Benet, A.

Palau Galindo, J.J. Cabr Vila, F. Dolz Andrs, M. Soler, M. Gracia Vidal, J. Vilalta J. Boj Casajuana, M. Ricard,

SUPPLEMENTARY DATA

2018 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc18-0836/-/DC1

F. Saiz, A. Isach, M. Sanchez Marin Martinez, E. Granado Font, C, Lucena Luque, M. Bull, N. Babio, N.

Becerra-Toms, G. Mestres, J. Basora, G. Mena-Snchez, L. Barrubs Piol, M. Gil Segura, C. Papandreou, N.

Rosique-Esteban, S. Chig, I. Abelln Cano, V. Ruiz Garca, A. Salas-Huetos, I. Paz-Graniel, L. Snchez Niembro,

P. Hernandez-Alonso, S. Canudas, L. Camacho-Barcia, J. Garca-Gaviln, A. Daz-Lpez.

Cardiovascular Risk and Nutrition Research Group, Servicio de Endocrinologa, IMIM (Hospital del Mar

Medical Research Institute), Barcelona. Departament de Medicina, Universitat Autnoma de Barcelona,

Barcelona, Spain: O. Castaer, M.A. Muoz, M.D. Zomeo, A. Hernaz, L. Torres, M. Quifer, R. Llimona, L.A.

Gal, A. Prez, M. Farrs, R. Elosua, J. Marrugat, J. Vila, I. Subirana, S. Prez, M.A. Muoz, A. Goday, J.J.

Chillaron Jordan, J.A. Flores Lerroux, D. Benaiges Boix, M. Farr, E. Menoyo, D. Muoz-Aguayo, S. Gaixas, G.

Blanchart, A. Sanllorente, M. Soria, J. Valussi, A. Cuenca, L. Forcano, A. Pastor, A. Boronat, S. Tello, M.

Cabaero, L. Franco, H. Schrder, R. De la Torre, C. Medrano, J. Bay, M.T. Garca, V. Robledo, P. Babi, E.

Canals, N. Soldevila, L. Carrs, C. Roca, M.S. Comas, G. Gasulla, X. Herraiz, A. Martnez, E. Vinyoles, J.M.

Verd, M. Masague Aguade, E. Baltasar Massip, M. Lopez Grau, M. Mengual, V. Moldon, M. Vila Vergaz, R.

Cabanes Gmez, Ciurana, M. Gili Riu, A. Palomeras Vidal.

Nutritional Epidemiology Unit, Miguel Hernandez University, ISABIAL-FIS

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