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Randomized Controlled Trial
. 2018 Nov 13;15(1):110.
doi: 10.1186/s12966-018-0741-x.

Effectiveness of the physical activity intervention program in the PREDIMED-Plus study: a randomized controlled trial

Helmut Schröder  1   2 , Gabriela Cárdenas-Fuentes  3   4 , Miguel Angel Martínez-González  5   6 , Dolores Corella  6   7 , Jesús Vioque  8   9 , Dora Romaguera  6   10 , J Alfredo Martínez  6   11   12 , Francisco J Tinahones  6   13 , José López Miranda  6   14 , Ramon Estruch  6   15 , Aurora Bueno-Cavanillas  6   16 , Fernando Arós  6   17 , Ascensión Marcos  6   18 , Josep A Tur  6   19 , Julia Warnberg  6   20 , Lluis Serra-Majem  6   21 , Vicente Martín  8   22 , Clotilde Vázquez  6   23 , José Lapetra  6   24 , Xavier Pintó  6   25 , Josep Vidal  26   27 , Lidia Daimiel  28 , José Juan Gaforio  8   29 , Pilar Matía-Martín  30 , Emilio Ros  6   31 , Olga Castañer  3   6 , Camille Lassale  32 , Miguel Ruiz-Canela  5   6 , Eva M Asensio  6   7 , Josep Basora  6   33 , Laura Torres-Collado  8   9 , Antonio Garcia-Rios  6   14 , Itziar Abete  6   11 , Estefania Toledo  5   6 , Pilar Buil-Cosiales  5   6   33 , Mònica Bullo  6   34 , Albert Goday  3   6   35 , Montserrat Fitó  3   6 , Jordi Salas-Salvadó  36   37   38 ; PREDIMED-Plus investigators
Affiliations
Randomized Controlled Trial

Effectiveness of the physical activity intervention program in the PREDIMED-Plus study: a randomized controlled trial

Helmut Schröder et al. Int J Behav Nutr Phys Act. .

Abstract

Background: The development and implementation of effective physical activity (PA) intervention programs is challenging, particularly in older adults. After the first year of the intervention program used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial, we assessed the initial effectiveness of the PA component.

Methods: PREDIMED-Plus is an ongoing randomized clinical trial including 6874 participants randomized to an intensive weight-loss lifestyle intervention based on an energy-restricted Mediterranean diet (MedDiet), physical activity promotion and behavioral support and to a control group using MedDiet recommendations but without calorie restriction or PA advice. Body mass index (BMI) and waist circumference (WC) are measured by standard clinical protocols. Duration and intensity of PA is self-reported using the validated REGICOR Short Physical Activity Questionnaire. The primary endpoint of the PREDIMED-Plus trial is a combined cardiovascular outcome: myocardial infarction (acute coronary syndromes with positive troponin test), stroke, or cardiovascular mortality. The present study involved secondary analysis of PA data (n = 6059; mean age 65 ± 4.9 years) with one-year changes in total, light, and moderate-to-vigorous PA within and between intervention groups as the outcome. Generalized estimating equation models were fitted to evaluate time trends of PA, BMI, and WC within groups and differences between intervention and control groups.

Results: After 12 months, average daily MVPA increased by 27.2 (95%CI 5.7;48.7) METs-min/day and 123.1 (95%CI 109.7-136.6) METs-min/day in the control and intervention groups, respectively. Total-PA, light-PA, and MVPA increased significantly (p < 0.01) in both groups. A significant (p < 0.001) time*intervention group interaction was found for Total-PA and MVPA, meaning the PA trajectory over time differed between the intervention and control groups. Age, sex, education level, and BMI did not moderate the effectiveness of the PA intervention. BMI and WC decreased significantly with increasing MVPA, compared with participants who reported no changes in MVPA.

Conclusion: After one year of follow-up, the PREDIMED-Plus PA intervention has been effective in increasing daily PA in older adults.

Trial registration: Retrospectively registered at the International Standard Randomized Controlled Trial ( http://www.isrctn.com/ISRCTN89898870 ), registration date: 24 July 2014.

Keywords: Body mass index; Intervention program; Older adults; Physical activity; Randomized control trial; Waist circumference.

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Conflict of interest statement

Ethics approval and consent to participate

Research Ethics Committees from all recruitment centers approved the study protocol, according to the ethical standards of the Declaration of Helsinki. All participants provided written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the PREDIMED Plus trial
Fig. 2
Fig. 2
Dose-effect association between one-year differences in moderate/vigorous physical activity and one-year differences in body mass index (BMI) and waist circumferences. a: BMI intervention group; b: BMI: control group; c: Waist circumferences intervention group; d: Waist circumferences control group. All models were adjusted for sex, age, smoking, educational level, and baseline value of the corresponding anthropometric variable. Moderate-to-vigorous PA (MVPA) was measured in METs·min/day
See this image and copyright information in PMC

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