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Article History

Received: 16 June 2021

Accepted: 11 October 2021

First Online: 25 October 2021

Declarations

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: The study was performed in accordance with the guidelines of the Declaration of Helsinki. All procedures were reviewed and approved by the ethics committees of the National Institutes of Biomedical Innovation, Health and Nutrition (6008, Kenei14-02), and the Okayama Health Foundation (Okakenrin-3, 20061005). All participants provided written consent for participation in the study. In 2019, 327 participants who were referred to the National Institutes of Biomedical Innovation, Health, and Nutrition in Tokyo renewed their consent, thereby granting access to the data of 583 participants for an additional 5-year period (Kenei102-01). The Nutrition and Exercise Intervention Study (NEXIS) was retrospectively registered in ClinicalTrials.gov (ID, NCT00926744) in June 2009, i.e., 3 years and 2 months after the study was officially started, or 2 years and 3 months after the enrollment of the first participant in March 2007. Twenty-seven participants conformed to the +2-year follow-up visit before the date of the registration. A total of 137 participants were enrolled after the date of the registration (Additional file : Table S3). Therefore, the present study should be characterized as exploratory, not confirmatory. In order to promote full transparency, deviations from the initial registration should be brought to the attention of the readers. The history of changes made to the registry are accessible at the following permanent link: . Between June 2009 and March 2017, a number of changes have been made to the registry to describe the NEXIS protocol more precisely. While participants of the NEXIS had been assigned to the active, control, or intervention groups since the first participant enrolled in the study in March 2007, the description of the three arms was only added in April 2015. By this date, all the participants included in the present analysis, except one, had already passed the +2-year follow-up visit (Additional file : Table S3). Some changes were made a posteriori to reflect the actual characteristics of the recruited population more accurately. In October 2012, the minimum age eligibility criteria was changed from 20 to 30 years old. By this date, all the recruited participants were at least 30 years old at the time of the baseline measurement, except one individual who passed the baseline visit at the age of 29 years and 360 days. In April 2015, the primary outcome was changed from “incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)—5 years” to “objectively measured amount of physical activity—10 years.” By this date, the NEXIS cohort was mainly composed of healthy and relatively active participants. In addition, inactive, hypertensive, dyslipidemic, and diabetic participants were overrepresented among the dropouts (Additional file : Table S4). Considering the impossibility to extend the period of observation beyond 10 years, the primary outcome was switched to the objectively measured amount of physical activity as a marker of the risk of lifestyle-related diseases.

: Not applicable.

: YG, MI, RK, HK, KK, MM, NM, AM, HM, HO, KS, NT, MT, KT, JT, and KY declare that they have no competing interests.