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: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Dyslipidemia
Diabetes
Low-back Pain and Knee Pain
Behavioral: physical activity
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People

Resource links provided by NLM:


Further study details as provided by National Institute of Health and Nutrition:

Primary Outcome Measures:
  • Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 1052
Study Start Date: April 2006
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
physical activity intervention
Behavioral: physical activity
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.

  Eligibility

Ages Eligible for Study:   30 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females
  • Ages 30-64 years old

Exclusion Criteria:

  • During treatment of any diseases
  • Two or more metabolic risk factors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926744

Locations
Japan
National Institute of Health and Nutrition
Shinjuku, Tokyo, Japan, 162-8636
Sponsors and Collaborators
National Institute of Health and Nutrition
  More Information

No publications provided

Responsible Party: Motohiko Miyachi, Chief, Department of Health Promotion and Exercise, National Institute of Health and Nutrition
ClinicalTrials.gov Identifier: NCT00926744     History of Changes
Other Study ID Numbers: qde402mm, 21170901
Study First Received: June 23, 2009
Last Updated: June 9, 2014
Health Authority: Japan: Foundation for Biomedical Research and Innovation

Keywords provided by National Institute of Health and Nutrition:
physical activity
nutrition
cardiovascular diseases

Additional relevant MeSH terms:
Back Pain
Cardiovascular Diseases
Hypertension
Low Back Pain
Dyslipidemias
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014