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Physical ActivityPhase 3NCT01295203

Internet-based Physical Activity Intervention

A Phase 3 study testing website assess in people with Physical Activity, run by University of Southern Denmark at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether access to a website with personalized feedback on physical activity level and suggestions to increase physical activity results in improvements in self-reported physical activity, anthropometrics and physiological measurements Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
website assess
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,287 participants
Where
4 sitesDenmark
Study dates
May 2008to May 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults
  • Physically inactive in leisure time (assessed by self reported questionnaire)

Who cannot join

  • Presence of serious heart problems or not being able to perform everyday activities
  • Highly physically active in leisure time (assessed by self reported questionnaire)

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • National Institute of Public Health

    Copenhagen, 1353

  • Municipality of Frederiksberg

    Frederiksberg, 2000

  • Municipality of Silkeborg

    Silkeborg, 8600

  • Municipality of Varde

    Varde, 6800

Other trials in Denmark

About this study

The purpose of this study is to determine whether access to a website with personalized feedback on physical activity level and suggestions to increase physical activity results in improvements in self-reported physical activity, anthropometrics and physiological measurements

Read the detailed description

In a website-based intervention study, the investigators wish to examine if it is possible to increase physical activity among inactive persons. Main objective is to determine if access to a website with personalized feedback on PA level and suggestions to increase PA results in improvements in self reported PA, anthropometrics and applied physiological measurements.

Physical inactive adults (n=12,287) participating in a nationwide health survey and examination (DANHES) were asked to randomly assigned to either intervention (n=6,055) or control group (n=6,232). The intervention group had access to a PA website with personalized advice and suggestions to increase PA. After 3 and 6 months, a follow-up questionnaire was administered by e-mail. The 7-day International Physical Activity Questionnaire was included in the questionnaires to assess four domains of PA in daily-life (work, transportation, domestic, and leisure-time) and sedentary time. Furthermore, at the 3 month follow-up a subgroup of participants (n=1,190) were invited complete anthropometrics and physiological measurements.

Being tested
website assess
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • website assessBehavioural

    The internet intervention group were given assess to the intervention website which included a personal page with tailored physical activity advice and a personal profile together with Recommendations and general training programs.

Study groups in NCT01295203
Study groupRoleWhat they receive
Control groupNo interventionThe control group were not given access to the intervention website and received no additional information.
Receives: Behavioral: website assess

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self reported physical activity

    Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)

    Measured: after 3 month

  2. Self reported physical activity

    Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)

    Measured: After 6 month

Secondary outcomes (7)

  1. Body weight

    Body weight was measured to the nearest 0.1 kg and percent point with a Segmeantal Body Composition Analyser (type BC-418 MA, Tanita Corp., Tokyo, Japan).

    Measured: after 3 month

  2. Fat percentage

    Fat percentage was measured to the nearest 0.1 kg and percent point with a Segmeantal Body Composition Analyser (type BC-418 MA, Tanita Corp., Tokyo, Japan).

    Measured: after 3 month

  3. Hip and Waist circumference

    Hip and waist circumference was measured with a body tape (Chasmors WM02 Body Tape, Chasmors Ltd.,London, United Kingdom) to the nearest 1.0 cm. Waist circumference was measured midway between the iliac crest and the costal margin following a quiet expiration, and lastly hip circumference was measured at the maximal circumference over the buttocks and below the iliac crest.

    Measured: after 3 month

  4. blood pressure

    Systolic and diastolic blood pressure were measured by fully automatic clinically validated blood pressure monitors (UA 779, UA-767 Plus 30 or UA 767 PC, A\&D Company Ltd, Tokyo, Japan)

    Measured: 3 month

  5. Aerobic fitness

    Estimated during a max (watt-max) or a sub-maximal test on a ergometer bike depending on the physical condition of the participant (Ergomedic 828E, Monark Exercise AB, Vansbro, Sweden). One of the following conditions contraindicated participation in the watt-max test: Any heart-related disease, chest pain, hypertension (>160/100 mmHg), heart or lung (pulmonary) medication, pregnancy and muscle, joint or skeletal problems. The sub-max test was contradicted by hypertension (>180/110 mmHg), severe heart-related disease, certain types of heart medication, muscle, joint or skeletal problems.

    Measured: after 3 month

  6. Arm muscle strength

    Arm mucle strength was measured by bending of the arms with a Takei TKK 5402 digital back strength dynamometer (Takei Scientific Instruments Co. Ltd., Tokyo, Japan). The test was performed with maximal exertion.

    Measured: after 3 month

  7. blood samples

    Non-fasting venous blood samples were collected for future analyses of P-cholesterol, P-triglyceride, and haemoglobin A1c and for biobank storage.

    Measured: After 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2011 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12,287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01295203
Sponsor's protocol ID
NIPH 1957
Status last verified
May 2008
First submitted
11 Feb 2011
Last updated
14 Feb 2011
Results posted
No
Data monitoring committee
No

Publications

  • Hansen AW, Gronbaek M, Helge JW, Severin M, Curtis T, Tolstrup JS. Effect of a Web-based intervention to promote physical activity and improve health among physically inactive adults: a population-based randomized controlled trial. J Med Internet Res. 2012 Oct 30;14(5):e145. doi: 10.2196/jmir.2109.

    PubMed 23111127

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing website assess in people with Physical Activity, run by University of Southern Denmark at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self reported physical activity (time frame: after 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01295203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011.

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