Nutrition and Exercise Intervention Study

NCT ID: NCT00926744

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1085 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Dyslipidemia Diabetes Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

Physically inactive participants receiving both physical activity and dietary counseling

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.

Active

Physically active participants receiving only dietary counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Control

Physically inactive participants receiving only dietary counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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physical activity

The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males and females
* Ages 30-64 years old

Exclusion Criteria

* During treatment of any diseases
* Two or more metabolic risk factors
Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Health and Nutrition

OTHER_GOV

Sponsor Role lead

Responsible Party

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Motohiko Miyachi

Chief, Department of Health Promotion and Exercise

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Health and Nutrition

Shinjuku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 34696811 (View on PubMed)

Other Identifiers

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21170901

Identifier Type: -

Identifier Source: secondary_id

qde402mm

Identifier Type: -

Identifier Source: org_study_id

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