Nutrition and Exercise Intervention Study (NEXIS)

March 27, 2017 updated by: Motohiko Miyachi, National Institute of Health and Nutrition

Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People

The purpose of the present study was to clarify the effects of increase in physical activity on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the present study was that the physical activity to satisfy the Japanese guideline of Ministry of Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1085

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku, Tokyo, Japan, 162-8636
        • National Institute of Health and Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females
  • Ages 30-64 years old

Exclusion Criteria:

  • During treatment of any diseases
  • Two or more metabolic risk factors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Physically inactive participants receiving both physical activity and dietary counseling
Behavioral: physical activity
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
No Intervention: Active
Physically active participants receiving only dietary counseling
No Intervention: Control
Physically inactive participants receiving only dietary counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objectively measured amount of physical activity
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
Time Frame: 5 years
5 years
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
Time Frame: 10 years
10 years
Incidence of musculoskeletal and joint pain
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Health and Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

April 1, 2014

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qde402mm
  • 21170901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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