Status unknownNCT00926744NEXISUpdated Mar 29, 2017

Nutrition and Exercise Intervention Study

An interventional study of physical activity in Hypertension, Dyslipidemia and Diabetes, sponsored by National Institute of Health and Nutrition. Status unknown at 1 site in Japan. Open to participants aged 30 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by National Institute of Health and Nutrition · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

Registered 3 years 2 months after the study started (first participant enrolled Apr 2006, registered Jun 2009).

Phase: Not applicable
Study type: Interventional
Enrollment: 1,085
Allocation: Randomized
Ages: 30 Years to 64 Years
Sex: All

Study 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.

Conditions studied

Hypertension
Dyslipidemia
Diabetes
Low Back Pain

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Keywords

physical activity
nutrition
cardiovascular diseases
musculo-skeletal problems

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 1,085 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

National Institute of Health and Nutrition is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Males and females
Ages 30-64 years old

Exclusion criteria

Exclusion Criteria:

During treatment of any diseases
Two or more metabolic risk factors

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 1,085 participants (actual)

Study arms

Experimental
Intervention
Physically inactive participants receiving both physical activity and dietary counseling
Behavioral: physical activity
No intervention
Active
Physically active participants receiving only dietary counseling
No intervention
Control
Physically inactive participants receiving only dietary counseling

Interventions

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

What researchers measure

Primary outcomes

Objectively measured amount of physical activity
Time frame: 10 years

Secondary outcomes

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

Study locations

1 site

National Institute of Health and Nutrition
Shinjuku, Tokyo 162-8636, Japan

References and documents

Publications

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. PubMed 34696811 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2006 to primary completion in Apr 2014, 96 months.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 96 months is above that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 23, 2009
First posted: Jun 24, 2009
StartActual: Apr 2006
Primary completionActual: Apr 2014
CompletionEst.: Mar 2018
Last update: Mar 29, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00926744
Lead sponsor: National Institute of Health and Nutrition
Responsible party: Motohiko Miyachi (Chief, Department of Health Promotion and Exercise, National Institute of Health and Nutrition) — Principal investigator
First posted: Jun 24, 2009
Start date: Apr 2006
Primary completion: Apr 2014
Completion: Mar 2018 (estimated)
Last update: Mar 29, 2017

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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