Nutrition and Exercise Intervention Study (NEXIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Motohiko Miyachi, National Institute of Health and Nutrition
ClinicalTrials.gov Identifier:
NCT00926744
First received: June 23, 2009
Last updated: April 13, 2015
Last verified: April 2015

June 23, 2009
April 13, 2015
April 2006
April 2014   (final data collection date for primary outcome measure)
Objectively measured amount of physical activity [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Incidence of musculoskeletal and joint pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) [ Time Frame: every year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
30 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00926744
qde402mm, 21170901
Yes
Motohiko Miyachi, National Institute of Health and Nutrition
National Institute of Health and Nutrition
Not Provided
Not Provided
National Institute of Health and Nutrition
April 2015

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