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Nutrition and Exercise Intervention Study (NEXIS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926744
First Posted: June 24, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Motohiko Miyachi, National Institute of Health and Nutrition
June 23, 2009
June 24, 2009
March 29, 2017
April 2006
April 2014   (Final data collection date for primary outcome measure)
Objectively measured amount of physical activity [ Time Frame: 10 years ]
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00926744 on ClinicalTrials.gov Archive Site
  • Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) [ Time Frame: 5 years ]
  • Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 10 years ]
  • Incidence of musculoskeletal and joint pain [ Time Frame: 1 year ]
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) [ Time Frame: every year ]
Not Provided
Not Provided
 
Nutrition and Exercise Intervention Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hypertension
  • Dyslipidemia
  • Diabetes
  • Low Back Pain
Behavioral: physical activity
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
  • Experimental: Intervention
    Physically inactive participants receiving both physical activity and dietary counseling
    Intervention: Behavioral: physical activity
  • No Intervention: Active
    Physically active participants receiving only dietary counseling
  • No Intervention: Control
    Physically inactive participants receiving only dietary counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1085
March 2018
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females
  • Ages 30-64 years old

Exclusion Criteria:

  • During treatment of any diseases
  • Two or more metabolic risk factors
Sexes Eligible for Study: All
30 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00926744
qde402mm
21170901
Yes
Not Provided
Not Provided
Motohiko Miyachi, National Institute of Health and Nutrition
National Institute of Health and Nutrition
Not Provided
Not Provided
National Institute of Health and Nutrition
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP