Supplementary Material for: Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial

Introduction: Large randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedD...

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Hauptverfasser: Díaz-López, A., Becerra-Tomás, N., Ruiz, V., Toledo, E., Babio, N., Corella, D., Fitó, M., Romaguera, D., Vioque, J., Alonso-Gómez Á.M., Wärnberg, J., Martínez, J.A., Serra-Majem, L., Estruch, R., Tinahones, F.J., Lapetra, J., Pintó, X., Tur, J.A., López-Miranda, J., CanoIbañez, N., Delgado-Rodríguez, M., Matía-Martín, P., Daimiel, L., DePaz, J.A., Vidal, J., Vázquez, C., Ruiz-Canela, M., Bulló, M., Sorlí, J.V., Goday, A., Fiol, M., García-De-La-Hera, M., TojalSierra, L., Pérez-Farinós, N., Zulet M.Á., Sánchez-Villegas, A., Sacanella, E., Fernández-García, J.C., Santos-Lozano, J.M., Gimenez-Gracia, M., DelMarBibiloni, M., Diez-Espino, J., Ortega-Azorin, C., Castañer, O., Morey, M., Torres-Collado, L., SortoSanchez, C., Muñoz M.Á., Ros, E., Martinez-Gonzalez, M.A., Salas-Salvadó, J., Investigators, The PREDIMED-Plus
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creator Díaz-López, A.
Becerra-Tomás, N.
Ruiz, V.
Toledo, E.
Babio, N.
Corella, D.
Fitó, M.
Romaguera, D.
Vioque, J.
Alonso-Gómez Á.M.
Wärnberg, J.
Martínez, J.A.
Serra-Majem, L.
Estruch, R.
Tinahones, F.J.
Lapetra, J.
Pintó, X.
Tur, J.A.
López-Miranda, J.
CanoIbañez, N.
Delgado-Rodríguez, M.
Matía-Martín, P.
Daimiel, L.
DePaz, J.A.
Vidal, J.
Vázquez, C.
Ruiz-Canela, M.
Bulló, M.
Sorlí, J.V.
Goday, A.
Fiol, M.
García-De-La-Hera, M.
TojalSierra, L.
Pérez-Farinós, N.
Zulet M.Á.
Sánchez-Villegas, A.
Sacanella, E.
Fernández-García, J.C.
Santos-Lozano, J.M.
Gimenez-Gracia, M.
DelMarBibiloni, M.
Diez-Espino, J.
Ortega-Azorin, C.
Castañer, O.
Morey, M.
Torres-Collado, L.
SortoSanchez, C.
Muñoz M.Á.
Ros, E.
Martinez-Gonzalez, M.A.
Salas-Salvadó, J.
Investigators, The PREDIMED-Plus
description Introduction: Large randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function. Methods: Randomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) adults aged 55–75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion, and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between September 2013 and December 2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of moderately/severely impaired eGFR (
doi_str_mv 10.6084/m9.figshare.13733335
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Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function. Methods: Randomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) adults aged 55–75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion, and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between September 2013 and December 2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of moderately/severely impaired eGFR (&lt;60 mL/min/1.73 m2) and micro- to macroalbuminuria (UACR ≥30 mg/g), and reversion of moderately (45 to &lt;60 mL/min/1.73 m2) to mildly impaired GFR (60 to &lt;90 mL/min/1.73 m2) or micro- to macroalbuminuria. Results: After 1 year, eGFR declined by 0.66 and 1.25 mL/min/1.73 m2 in the intervention and control groups, respectively (mean difference, 0.58 mL/min/1.73 m2; 95% CI: 0.15–1.02). There were no between-group differences in mean UACR or micro- to macroalbuminuria changes. Moderately/severely impaired eGFR incidence and reversion of moderately to mildly impaired GFR were 40% lower (HR 0.60; 0.44–0.82) and 92% higher (HR 1.92; 1.35–2.73), respectively, in the intervention group. Conclusions: The PREDIMED-Plus lifestyle intervention approach may preserve renal function and delay CKD progression in overweight/obese adults.</description><identifier>DOI: 10.6084/m9.figshare.13733335</identifier><language>eng</language><publisher>Karger Publishers</publisher><subject>Medicine</subject><creationdate>2021</creationdate><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>777,1888</link.rule.ids><linktorsrc>$$Uhttps://commons.datacite.org/doi.org/10.6084/m9.figshare.13733335$$EView_record_in_DataCite.org$$FView_record_in_$$GDataCite.org$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>Díaz-López, A.</creatorcontrib><creatorcontrib>Becerra-Tomás, N.</creatorcontrib><creatorcontrib>Ruiz, V.</creatorcontrib><creatorcontrib>Toledo, E.</creatorcontrib><creatorcontrib>Babio, N.</creatorcontrib><creatorcontrib>Corella, D.</creatorcontrib><creatorcontrib>Fitó, M.</creatorcontrib><creatorcontrib>Romaguera, D.</creatorcontrib><creatorcontrib>Vioque, J.</creatorcontrib><creatorcontrib>Alonso-Gómez Á.M.</creatorcontrib><creatorcontrib>Wärnberg, J.</creatorcontrib><creatorcontrib>Martínez, J.A.</creatorcontrib><creatorcontrib>Serra-Majem, L.</creatorcontrib><creatorcontrib>Estruch, R.</creatorcontrib><creatorcontrib>Tinahones, F.J.</creatorcontrib><creatorcontrib>Lapetra, J.</creatorcontrib><creatorcontrib>Pintó, X.</creatorcontrib><creatorcontrib>Tur, J.A.</creatorcontrib><creatorcontrib>López-Miranda, J.</creatorcontrib><creatorcontrib>CanoIbañez, N.</creatorcontrib><creatorcontrib>Delgado-Rodríguez, M.</creatorcontrib><creatorcontrib>Matía-Martín, P.</creatorcontrib><creatorcontrib>Daimiel, L.</creatorcontrib><creatorcontrib>DePaz, J.A.</creatorcontrib><creatorcontrib>Vidal, J.</creatorcontrib><creatorcontrib>Vázquez, C.</creatorcontrib><creatorcontrib>Ruiz-Canela, M.</creatorcontrib><creatorcontrib>Bulló, M.</creatorcontrib><creatorcontrib>Sorlí, J.V.</creatorcontrib><creatorcontrib>Goday, A.</creatorcontrib><creatorcontrib>Fiol, M.</creatorcontrib><creatorcontrib>García-De-La-Hera, M.</creatorcontrib><creatorcontrib>TojalSierra, L.</creatorcontrib><creatorcontrib>Pérez-Farinós, N.</creatorcontrib><creatorcontrib>Zulet M.Á.</creatorcontrib><creatorcontrib>Sánchez-Villegas, A.</creatorcontrib><creatorcontrib>Sacanella, E.</creatorcontrib><creatorcontrib>Fernández-García, J.C.</creatorcontrib><creatorcontrib>Santos-Lozano, J.M.</creatorcontrib><creatorcontrib>Gimenez-Gracia, M.</creatorcontrib><creatorcontrib>DelMarBibiloni, M.</creatorcontrib><creatorcontrib>Diez-Espino, J.</creatorcontrib><creatorcontrib>Ortega-Azorin, C.</creatorcontrib><creatorcontrib>Castañer, O.</creatorcontrib><creatorcontrib>Morey, M.</creatorcontrib><creatorcontrib>Torres-Collado, L.</creatorcontrib><creatorcontrib>SortoSanchez, C.</creatorcontrib><creatorcontrib>Muñoz M.Á.</creatorcontrib><creatorcontrib>Ros, E.</creatorcontrib><creatorcontrib>Martinez-Gonzalez, M.A.</creatorcontrib><creatorcontrib>Salas-Salvadó, J.</creatorcontrib><creatorcontrib>Investigators, The PREDIMED-Plus</creatorcontrib><title>Supplementary Material for: Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial</title><description>Introduction: Large randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function. Methods: Randomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) adults aged 55–75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion, and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between September 2013 and December 2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of moderately/severely impaired eGFR (&lt;60 mL/min/1.73 m2) and micro- to macroalbuminuria (UACR ≥30 mg/g), and reversion of moderately (45 to &lt;60 mL/min/1.73 m2) to mildly impaired GFR (60 to &lt;90 mL/min/1.73 m2) or micro- to macroalbuminuria. Results: After 1 year, eGFR declined by 0.66 and 1.25 mL/min/1.73 m2 in the intervention and control groups, respectively (mean difference, 0.58 mL/min/1.73 m2; 95% CI: 0.15–1.02). There were no between-group differences in mean UACR or micro- to macroalbuminuria changes. Moderately/severely impaired eGFR incidence and reversion of moderately to mildly impaired GFR were 40% lower (HR 0.60; 0.44–0.82) and 92% higher (HR 1.92; 1.35–2.73), respectively, in the intervention group. Conclusions: The PREDIMED-Plus lifestyle intervention approach may preserve renal function and delay CKD progression in overweight/obese adults.</description><subject>Medicine</subject><fulltext>true</fulltext><rsrctype>dataset</rsrctype><creationdate>2021</creationdate><recordtype>dataset</recordtype><sourceid>PQ8</sourceid><recordid>eNo1kMFqwzAMhnPZYXR7gx30AsmcxUnj3kpot7KUwVbYMSi23BoSuzhuoXuBvfaSbRUCiV_iF_qi6CFlScFK_tiLRJv9cEBPSZrNszHy2-j743Q8dtSTDegvsMVA3mAH2vkFrLQmGcBpQAsbG8gO5kzwSWZ_CHHthgFqo2kIl45-5_48-hhnYcxXoyxdYH2ycpIWsIR3tMr15osUVM4G77pubHfTwbvoRmM30P1_nUW79WpXvcT12_OmWtaxEmkeY1EwWbapLLjIW4YFz3k7x5aQE8-JpexJikyMWjktCtUyUVIpkDNdSsWyWcT_bBUGlCZQc_SmHz9vUtZMmJpeNFdMzRVT9gMDD2ZU</recordid><startdate>20210208</startdate><enddate>20210208</enddate><creator>Díaz-López, A.</creator><creator>Becerra-Tomás, N.</creator><creator>Ruiz, V.</creator><creator>Toledo, E.</creator><creator>Babio, N.</creator><creator>Corella, D.</creator><creator>Fitó, M.</creator><creator>Romaguera, 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M.Á.</creatorcontrib><creatorcontrib>Sánchez-Villegas, A.</creatorcontrib><creatorcontrib>Sacanella, E.</creatorcontrib><creatorcontrib>Fernández-García, J.C.</creatorcontrib><creatorcontrib>Santos-Lozano, J.M.</creatorcontrib><creatorcontrib>Gimenez-Gracia, M.</creatorcontrib><creatorcontrib>DelMarBibiloni, M.</creatorcontrib><creatorcontrib>Diez-Espino, J.</creatorcontrib><creatorcontrib>Ortega-Azorin, C.</creatorcontrib><creatorcontrib>Castañer, O.</creatorcontrib><creatorcontrib>Morey, M.</creatorcontrib><creatorcontrib>Torres-Collado, L.</creatorcontrib><creatorcontrib>SortoSanchez, C.</creatorcontrib><creatorcontrib>Muñoz M.Á.</creatorcontrib><creatorcontrib>Ros, E.</creatorcontrib><creatorcontrib>Martinez-Gonzalez, M.A.</creatorcontrib><creatorcontrib>Salas-Salvadó, J.</creatorcontrib><creatorcontrib>Investigators, The PREDIMED-Plus</creatorcontrib><collection>DataCite (Open Access)</collection><collection>DataCite</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Díaz-López, A.</au><au>Becerra-Tomás, N.</au><au>Ruiz, V.</au><au>Toledo, E.</au><au>Babio, N.</au><au>Corella, D.</au><au>Fitó, M.</au><au>Romaguera, D.</au><au>Vioque, J.</au><au>Alonso-Gómez Á.M.</au><au>Wärnberg, J.</au><au>Martínez, J.A.</au><au>Serra-Majem, L.</au><au>Estruch, R.</au><au>Tinahones, F.J.</au><au>Lapetra, J.</au><au>Pintó, X.</au><au>Tur, J.A.</au><au>López-Miranda, J.</au><au>CanoIbañez, N.</au><au>Delgado-Rodríguez, M.</au><au>Matía-Martín, P.</au><au>Daimiel, L.</au><au>DePaz, J.A.</au><au>Vidal, J.</au><au>Vázquez, C.</au><au>Ruiz-Canela, M.</au><au>Bulló, M.</au><au>Sorlí, J.V.</au><au>Goday, A.</au><au>Fiol, M.</au><au>García-De-La-Hera, M.</au><au>TojalSierra, L.</au><au>Pérez-Farinós, N.</au><au>Zulet M.Á.</au><au>Sánchez-Villegas, A.</au><au>Sacanella, E.</au><au>Fernández-García, J.C.</au><au>Santos-Lozano, J.M.</au><au>Gimenez-Gracia, M.</au><au>DelMarBibiloni, M.</au><au>Diez-Espino, J.</au><au>Ortega-Azorin, C.</au><au>Castañer, O.</au><au>Morey, M.</au><au>Torres-Collado, L.</au><au>SortoSanchez, C.</au><au>Muñoz M.Á.</au><au>Ros, E.</au><au>Martinez-Gonzalez, M.A.</au><au>Salas-Salvadó, J.</au><au>Investigators, The PREDIMED-Plus</au><format>book</format><genre>unknown</genre><ristype>DATA</ristype><title>Supplementary Material for: Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial</title><date>2021-02-08</date><risdate>2021</risdate><abstract>Introduction: Large randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function. Methods: Randomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) adults aged 55–75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion, and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between September 2013 and December 2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of moderately/severely impaired eGFR (&lt;60 mL/min/1.73 m2) and micro- to macroalbuminuria (UACR ≥30 mg/g), and reversion of moderately (45 to &lt;60 mL/min/1.73 m2) to mildly impaired GFR (60 to &lt;90 mL/min/1.73 m2) or micro- to macroalbuminuria. Results: After 1 year, eGFR declined by 0.66 and 1.25 mL/min/1.73 m2 in the intervention and control groups, respectively (mean difference, 0.58 mL/min/1.73 m2; 95% CI: 0.15–1.02). There were no between-group differences in mean UACR or micro- to macroalbuminuria changes. Moderately/severely impaired eGFR incidence and reversion of moderately to mildly impaired GFR were 40% lower (HR 0.60; 0.44–0.82) and 92% higher (HR 1.92; 1.35–2.73), respectively, in the intervention group. Conclusions: The PREDIMED-Plus lifestyle intervention approach may preserve renal function and delay CKD progression in overweight/obese adults.</abstract><pub>Karger Publishers</pub><doi>10.6084/m9.figshare.13733335</doi><oa>free_for_read</oa></addata></record>
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identifier DOI: 10.6084/m9.figshare.13733335
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title Supplementary Material for: Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial
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