Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000966998
Ethics application status
Approved
Date submitted
3/09/2011
Date registered
8/09/2011
Date last updated
8/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Face-to-Face vs. E-mail Communication on Fitness and Quality of Life in an Employee-Based Walking Program
Scientific title
Among employees enrolled in a work-based walking program, is e-mail communication comparable to face-to-face communication for fitness and quality of life outcomes?
Secondary ID [1] 262983 0
Nil
Universal Trial Number (UTN)
U1111-1124-2651
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Fitness 270704 0
Physical Activity Level 270705 0
Quality of Life 270706 0
Condition category
Condition code
Public Health 270882 270882 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 10-week walking program began by requiring participants to engage in 20 minutes of moderate intensity walking, defined by a rating of perceived exertion (RPE) of 12, 3 days per week. RPE is a validated scale for self-regulation of exercise intensity. An RPE rating of 12-13 corresponds with "somewhat hard" exercise, and approximately 60% Heart Rate Reserve. On alternating weeks, the required walks increased in either intensity (RPE 14) or duration (5 minutes). By the of the 10 week program, participants were walking for 45 minutes a day, 4 days per week, at an RPE of 14.

The intervention group had a face-to-face meeting with the researcher once a week. During these small group meetings (3-4 participants plus the instructor), the subjects completed one of their weekly walks with the researcher and were provided with verbal feedback based on a physical copy of a weekly workout log returned to the instructor. They were also provided with verbal encouragement and instruction for the next week.
Intervention code [1] 269325 0
Behaviour
Intervention code [2] 269355 0
Lifestyle
Comparator / control treatment
The control group was subject to the same walking progression. However, they received the same weekly motivational and instructional material through e-mail only. Weekly workout logs were submitted to the researcher via e-mail.
Control group
Active

Outcomes
Primary outcome [1] 279561 0
WHOQOL-BREF score and sub-scores. The WHOQOL-BREF is a questionnaire which assesses overall quality of life, and breaks it into the following domains: physical health, psychological health, social relationships, and environment.
Timepoint [1] 279561 0
Week 0 and Week 10
Primary outcome [2] 279562 0
Rockport Walk Test. Based on the time to completion and Heart Rate upon completion, the Rockport 1-mile Walk Test is used as an estimate of cardiovascular fitness. It has been validated as an accurate tool for estimating VO2max (maximal oxygen capacity).
Timepoint [2] 279562 0
Week 0 and Week 10
Primary outcome [3] 279563 0
Treadmill Test. Subjects walk on a treadmill set at 1% grade and 3.5 mph for 5 minutes, while wearing a heart rate monitor. At the end of each minute, the subject's heart rate is recorded by the researcher. This assessment allows the researcher to study the subject's heart rate response to a standard level of exercise. While the Rockport Walk Test allows each subject to self-select walking speed, this test allows the researcher to control for walking speed, to further isolate heart rate response pre- and post-intervention.
Timepoint [3] 279563 0
Week 0 and Week 10
Secondary outcome [1] 287902 0
Weight change. Broadly assessed as "loss," "no change," or "gain" on an anonymous post-participation survey.
Timepoint [1] 287902 0
3 months after end of intervention
Secondary outcome [2] 287962 0
Program enjoyment. Rated on a Likert scale of 1-5 on an anonymous post-participation survey.
Timepoint [2] 287962 0
3 months after end of intervention
Secondary outcome [3] 287963 0
Program benefit. Rated on a Likert scale of 1-5 on an anonymous post-participation survey.
Timepoint [3] 287963 0
3 months after end of intervention
Secondary outcome [4] 287964 0
Current Walking Status. Reported as "0-1 days/week," "2-3 days/week," or "4+ days/week" on an anonymous post-participation survey.
Timepoint [4] 287964 0
3 months after end of intervention
Secondary outcome [5] 287965 0
Perceived helpfulness of meeting. Rated on a Likert scale of 1-5 on an anonymous post-participation survey.
Timepoint [5] 287965 0
3 months after end of intervention

Eligibility
Key inclusion criteria
Previously sedentary/low-active Messiah College Employees
Minimum age
42 Years
Maximum age
56 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Already moderately/high active individuals or individuals not cleared to participate in moderate intensity exercise

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3823 0
United States of America
State/province [1] 3823 0
PA

Funding & Sponsors
Funding source category [1] 269793 0
Self funded/Unfunded
Name [1] 269793 0
Country [1] 269793 0
Primary sponsor type
University
Name
Messiah College Department of Health and Human PErformance
Address
One College Avenue
Grantham, PA 17027
Country
United States of America
Secondary sponsor category [1] 268827 0
None
Name [1] 268827 0
Address [1] 268827 0
Country [1] 268827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271748 0
Messiah College IRB
Ethics committee address [1] 271748 0
Ethics committee country [1] 271748 0
United States of America
Date submitted for ethics approval [1] 271748 0
27/07/2010
Approval date [1] 271748 0
17/08/2010
Ethics approval number [1] 271748 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33112 0
Address 33112 0
Country 33112 0
Phone 33112 0
Fax 33112 0
Email 33112 0
Contact person for public queries
Name 16359 0
Amy Chrisfield
Address 16359 0
3601 Spring Garden Street
3rd Floor
Philadelphia, PA 19104
Country 16359 0
United States of America
Phone 16359 0
+1, 315, 396-3114
Fax 16359 0
Email 16359 0
[email protected]
Contact person for scientific queries
Name 7287 0
Amy Chrisfield
Address 7287 0
3601 Spring Garden Street
3rd Floor
Philadelphia, PA 19104
Country 7287 0
United States of America
Phone 7287 0
+1, 315, 396-3114
Fax 7287 0
Email 7287 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.