Internet-based Physical Activity Intervention

This study has been completed.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01295203
First received: February 11, 2011
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Physical Activity
Behavioral: website assess
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Internet-based Physical Activity Intervention

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Self reported physical activity [ Time Frame: after 3 month ] [ Designated as safety issue: No ]
    Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)

  • Self reported physical activity [ Time Frame: After 6 month ] [ Designated as safety issue: No ]
    Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)


Secondary Outcome Measures:
  • Body weight [ Time Frame: after 3 month ] [ Designated as safety issue: No ]
    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).

  • Fat percentage [ Time Frame: after 3 month ] [ Designated as safety issue: No ]
    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).

  • Hip and Waist circumference [ Time Frame: after 3 month ] [ Designated as safety issue: No ]
    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.

  • blood pressure [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    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)

  • Aerobic fitness [ Time Frame: after 3 month ] [ Designated as safety issue: No ]
    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.

  • Arm muscle strength [ Time Frame: after 3 month ] [ Designated as safety issue: No ]
    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.

  • blood samples [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
    Non-fasting venous blood samples were collected for future analyses of P-cholesterol, P-triglyceride, and haemoglobin A1c and for biobank storage.


Enrollment: 12287
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
The control group were not given access to the intervention website and received no additional information.
Behavioral: website assess
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295203

Locations
Denmark
National Institute of Public Health
Copenhagen, Denmark, 1353
Municipality of Frederiksberg
Frederiksberg, Denmark, 2000
Municipality of Silkeborg
Silkeborg, Denmark, 8600
Municipality of Varde
Varde, Denmark, 6800
Sponsors and Collaborators
University of Southern Denmark
Rigshospitalet, Denmark
Investigators
Principal Investigator: Andreas Wolff Hansen, Msc. National Institute of public Health
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andreas Wolff Hansen, National Institute of Public Health, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01295203     History of Changes
Other Study ID Numbers: NIPH 1957
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on July 29, 2014