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Nutrition and Exercise Intervention Study (NEXIS)

Primary Purpose

Hypertension, Dyslipidemia, Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
physical activity
Sponsored by
National Institute of Health and Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring physical activity, nutrition, cardiovascular diseases, musculo-skeletal problems

Eligibility Criteria

30 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females
  • Ages 30-64 years old

Exclusion Criteria:

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

Sites / Locations

  • National Institute of Health and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Intervention

Active

Control

Arm Description

Physically inactive participants receiving both physical activity and dietary counseling

Physically active participants receiving only dietary counseling

Physically inactive participants receiving only dietary counseling

Outcomes

Primary Outcome Measures

Objectively measured amount of physical activity

Secondary Outcome Measures

Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
Incidence of musculoskeletal and joint pain

Full Information

First Posted
June 23, 2009
Last Updated
March 27, 2017
Sponsor
National Institute of Health and Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT00926744
Brief Title
Nutrition and Exercise Intervention Study
Acronym
NEXIS
Official Title
Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Health and Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia, Diabetes, Low Back Pain
Keywords
physical activity, nutrition, cardiovascular diseases, musculo-skeletal problems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1085 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Physically inactive participants receiving both physical activity and dietary counseling
Arm Title
Active
Arm Type
No Intervention
Arm Description
Physically active participants receiving only dietary counseling
Arm Title
Control
Arm Type
No Intervention
Arm Description
Physically inactive participants receiving only dietary counseling
Intervention Type
Behavioral
Intervention Name(s)
physical activity
Intervention Description
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
Primary Outcome Measure Information:
Title
Objectively measured amount of physical activity
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
Time Frame
5 years
Title
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
Time Frame
10 years
Title
Incidence of musculoskeletal and joint pain
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females Ages 30-64 years old Exclusion Criteria: During treatment of any diseases Two or more metabolic risk factors
Facility Information:
Facility Name
National Institute of Health and Nutrition
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
162-8636
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34696811
Citation
Tripette J, Gando Y, Murakami H, Kawakami R, Tanisawa K, Ohno H, Konishi K, Tanimoto M, Tanaka N, Kawano H, Yamamoto K, Morishita A, Iemitsu M, Sanada K, Miyatake N, Miyachi M. Effect of a 1-year intervention comprising brief counselling sessions and low-dose physical activity recommendations in Japanese adults, and retention of the effect at 2 years: a randomized trial. BMC Sports Sci Med Rehabil. 2021 Oct 25;13(1):133. doi: 10.1186/s13102-021-00360-7.
Results Reference
derived

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Nutrition and Exercise Intervention Study

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