- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295203
Internet-based Physical Activity Intervention
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Copenhagen, Denmark, 1353
- National Institute of Public Health
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Frederiksberg, Denmark, 2000
- Municipality of Frederiksberg
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Silkeborg, Denmark, 8600
- Municipality of Silkeborg
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Varde, Denmark, 6800
- Municipality of Varde
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults
- Physically inactive in leisure time (assessed by self reported questionnaire)
Exclusion Criteria:
- Presence of serious heart problems or not being able to perform everyday activities
- Highly physically active in leisure time (assessed by self reported questionnaire)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group were not given access to the intervention website and received no additional information.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self reported physical activity
Time Frame: after 3 month
|
Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)
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after 3 month
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Self reported physical activity
Time Frame: After 6 month
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Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)
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After 6 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: after 3 month
|
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).
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after 3 month
|
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Fat percentage
Time Frame: after 3 month
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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).
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after 3 month
|
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Hip and Waist circumference
Time Frame: after 3 month
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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.
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after 3 month
|
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blood pressure
Time Frame: 3 month
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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)
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3 month
|
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Aerobic fitness
Time Frame: after 3 month
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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.
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after 3 month
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Arm muscle strength
Time Frame: after 3 month
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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.
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after 3 month
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blood samples
Time Frame: After 3 months
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Non-fasting venous blood samples were collected for future analyses of P-cholesterol, P-triglyceride, and haemoglobin A1c and for biobank storage.
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After 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreas Wolff Hansen, Msc., National Institute of Public Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NIPH 1957
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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