Internet-based Physical Activity Intervention

Physical Activity Clinical Trial

Official title:

Internet-based Physical Activity Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295203
• Other study ID #: NIPH 1957
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2011
• Last updated: February 11, 2011
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2008
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12287
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health	Copenhagen
Denmark	Municipality of Frederiksberg	Frederiksberg
Denmark	Municipality of Silkeborg	Silkeborg
Denmark	Municipality of Varde	Varde

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported physical activity	Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)	after 3 month	No
Primary	Self reported physical activity	Physical activity was assessed self reported with the International Physical Activity Questionnaire (IPAQ)	After 6 month	No
Secondary	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).	after 3 month	No
Secondary	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).	after 3 month	No
Secondary	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.	after 3 month	No
Secondary	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)	3 month	No
Secondary	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.	after 3 month	No
Secondary	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.	after 3 month	No
Secondary	blood samples	Non-fasting venous blood samples were collected for future analyses of P-cholesterol, P-triglyceride, and haemoglobin A1c and for biobank storage.	After 3 months	No