Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000927628
Ethics application status
Approved
Date submitted
22/08/2014
Date registered
28/08/2014
Date last updated
1/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
REACH (Rural Environments And Community Health): an online physical activity intervention for insufficiently active adults living in rural South Australia
Scientific title
REACH (Rural Environments And Community Health): evaluation of an online physical activity intervention on physical activity levels for insufficiently active adults living in rural South Australia
Secondary ID [1] 285206 0
Nil
Universal Trial Number (UTN)
Trial acronym
REACH (Rural Environments And Community Health)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 292822 0
cardiovascular risk factors 292872 0
metabolic syndrome 292873 0
psychological wellbeing 292874 0
Condition category
Condition code
Cardiovascular 293120 293120 0 0
Other cardiovascular diseases
Mental Health 293121 293121 0 0
Other mental health disorders
Public Health 293122 293122 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will partake in a 12-week physical activity program during which they will wear a pedometer and use an online resource. The main focus of the online resource is a step log where participants enter their daily step counts, perception of exertion (RPE) and feeling (affect) daily. Based on this information they will be emailed weekly step count goals. The website will also include an interactive forum that links participants to other participants undertaking the study in the intervention group. There will be a virtual notice board where community service organisers can advertise events and activities relating to physical activity and general health and wellbeing. Information on healthy eating will be provided based on the recommendations in The Australian Guide to Healthy Eating (developed by the Australian Government, Department of Health and Aging). Participants are free to use (or not use) the program at their discretion. Adherence will be monitored by the number of logins to the website and progress phone calls which will occur weekly, but taper off as the intervention progresses and to foster independence.

Health measures such as height, weight, blood pressure, waist and hip girths and blood chemistry will be collected. Participants will also be asked to fill out questionnaires relating to their physical and psychological wellbeing and complete a food frequency questionnaire.
Intervention code [1] 290080 0
Lifestyle
Intervention code [2] 290117 0
Behaviour
Comparator / control treatment
The control group will also be asked to wear a pedometer over the 12-week program. However, they will receive a paper logbook to record their daily step counts instead of access to the website. They will receive only one progress phone call (week 2) to ensure they understand their requirements for the study. They will receive weekly step goal emails, however these will be standardized across all control participants, with the aim of reaching the recommended 10,000 steps in week 12 of the program
Control group
Active

Outcomes
Primary outcome [1] 292984 0
Physical activity levels as measured by a wrist-worn tri-axial accelerometer (GENEActiv). Step data recorded during the program by participants will also be assessed.
Timepoint [1] 292984 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [1] 310079 0
Clustered metabolic risk. Defined by both the National Cholesterol Education Program and International Diabetes Federation criteria.

Tool are outlined in individual outcome measures below.
Timepoint [1] 310079 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [2] 310080 0
Resting Blood Pressure. Measured using GE Healthcare Carescape V100 Automated sphygmomanometer.
Timepoint [2] 310080 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [3] 310081 0
Blood cholesterol. Measured by fasting finger prick blood sample by an Alere Cholestech LDX analyzer.
Timepoint [3] 310081 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [4] 310082 0
fasted blood glucose. Measured by fasting finger prick blood sample by an Alere Cholestech LDX analyzer.
Timepoint [4] 310082 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [5] 310196 0
percentage body-fat. Measured using a four-electrode 50Hz bioelectrical impedence analysis scales (Tanita BC-418)
Timepoint [5] 310196 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [6] 310197 0
Psychological wellbeing. Symptomatology of depression, anxiety and psychological stress will be assessed by the DASS-21. Salivary cortisol levels will be assessed at baseline and intervention-end only as a physiological marker of psychological distress.
Timepoint [6] 310197 0
DASS-21: Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52).

Salivary Cortisol: Baseline (week 0) and intervention end (week 13) only.
Secondary outcome [7] 310198 0
Dietary habits (consumption of core foods and non-core foods) as measured by the Cancer Council of Victoria's Dietary Questionnaire For Epidemiological Studies.
Timepoint [7] 310198 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [8] 310201 0
Exercise self-efficacy. Custom-made questionnaire using questions modified from Nigg & Riebe (2002) (Barrier self-efficacy) and Schwarzer et al. (2007) (relapse self-efficacy).
Timepoint [8] 310201 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)
Secondary outcome [9] 310202 0
Perceptions of physical environment for physical activity. Custom made questionnaire using questions modified from De Bourdeaudhuij, Sallis & Saelens (2003).
Timepoint [9] 310202 0
Baseline (week 0), intervention end (week 13), 6-month follow-up (week 26) and 12-month follow-up (week 52)

Eligibility
Key inclusion criteria
- Men or women age 18 - 74 years
- Resident of the Riverland and Yorke Peninsula regions of South Australia for at least 12-months
- Insufficiently active (engaging in less that 20 bouts of physical activity of atleast 30 minutes) over the previous month
- Deemed to be safe to participate in unsupervised moderate intensity exercise by satisfaction of stage one of the Adults Pre-exercise Screening System
- Sufficient englich language skills and cognitive ability as to allow full participation in the study
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Non-resident of the Riverland or Yorke Peninsula regions of South Australia, or resident <12-months
- Relocation out of study regions during the study period
- Pregnant or intending to become pregnant during 12-month study period
- Physical or psychological conditions (i.e. congnitive impairment) that may impede full participation in the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 300 participants (150 per region) at baseline will provide sufficient statistical power to address the study aims, given the attrition rate of 30% observed in our recent pilot pedometer intervention. At a power at 80%, alpha at 0.01, a medium effect size of Cohen`s d = 0.5, and assuming that the predictors will contribute an R2 of 50%, a sample size of 212 is required. With a 70% retention rate a baseline sample of 300 will be adequate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2013
Actual
22/05/2013
Date of last participant enrolment
Anticipated
Actual
29/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289822 0
Charities/Societies/Foundations
Name [1] 289822 0
National Heart Foundation of Australia (South Australian Division)
Country [1] 289822 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Frome Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 288514 0
None
Name [1] 288514 0
Address [1] 288514 0
Country [1] 288514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291553 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 291553 0
Frome Rd, Adelaide SA 5000
Ethics committee country [1] 291553 0
Australia
Date submitted for ethics approval [1] 291553 0
01/05/2013
Approval date [1] 291553 0
15/05/2013
Ethics approval number [1] 291553 0
0000031466

Summary
Brief summary
The aim of the study is to test the effectiveness of an online resource to increase physical activity (primarily walking) among rural South Australian adults. Registration is open for any adult (aged 18 - 74) whose primary residence is in either the Riverland or Yorke Peninsula regions of South Australia and who are currently insufficiently active (i.e. participated in less than 20 bouts of physical activity lasting at least 30 minutes in the previous month). Registered participants will also require ongoing access to the internet. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in the intervention group will take part in a 12-week lifestyle program during which they will wear a pedometer and use an online resource. The main focus of the online resource is a step log where participants enter their daily step counts, perception of exertion and feeling daily. Based on this information they will be emailed weekly step count goals. The website will also include an interactive forum that links participants to other participants in the intervention group. There will be a virtual notice board where community service organisers can advertise events and activities relating to physical activity and healthy eating. Information on healthy eating will be provided based on The Australian Guide to Healthy Eating. Intervention group participants will receive weekly progress phone calls which will be tapered off towards the end of the study period to foster independence. Participants are free to use (or not use) the program at their discretion. Participants in the other group will receive a pedometer, standard step log diary (paper form) and one progress phone call (week 2). They will receive step goal emails, however these will be generic (versus individualized) with the intention of reaching the recommended 10,000 steps by week 12. Health, physical activity and psychological wellbeing measures will be taken at baseline and intervention-end, as well as 6-month and 12-month follow-up.
Trial website
The REACH website has since been taken down with the cessation of the intervention phase.
Trial related presentations / publications
Mitchell BL, Lewis NR, Smith AE, Rowlands AV, Parfitt G, Dollman J. Rural Environments and Community Health (REACH): a randomised controlled trial protocol for an online walking intervention in rural adults. BMC Public Health. 2014; 14(1):969. DOI:10.1186/1471-2458-14-969
Public notes
Nigg, C. R. and Riebe, D. (2002) The transtheoretical model: research review of exercise behavior and older adults. In Burbank, P. and Riebe, D. (eds), Exercise and Behavior Change in Older Adults: Interventions with the Transtheoretical Model. Springer, New York, p. 147.

Schwarzer, R., Schuz, B., Ziegelmann, J.P., Lippke, S., Luszczynska, A., & Scholz, U. (2007). Adoption and maintenance of four health behaviors: theory-guided longitudinal studies on dental flossing, seat belt use, dietary behavior, and physical activity. Annals of Behavioral Medicine, 33, 156-166.

De Bourdeaudhuij I, Sallis JF, Saelens, BE. Environmental Correlates of Physical Activity in a Sample of Belgian Adults, Am J Health Promot 2003;18[1]:83–92.

Contacts
Principal investigator
Name 50850 0
A/Prof James Dollman
Address 50850 0
University of South Australia GPO Box 2471 Adelaide SA 5001
Country 50850 0
Australia
Phone 50850 0
+61 08 8302 1413
Fax 50850 0
Email 50850 0
james.dollman@unisa.edu.au
Contact person for public queries
Name 50851 0
A/Prof James Dollman
Address 50851 0
University of South Australia GPO Box 2471 Adelaide SA 5001
Country 50851 0
Australia
Phone 50851 0
+61 08 8302 1413
Fax 50851 0
Email 50851 0
james.dollman@unisa.edu.au
Contact person for scientific queries
Name 50852 0
A/Prof James Dollman
Address 50852 0
University of South Australia GPO Box 2471 Adelaide SA 5001
Country 50852 0
Australia
Phone 50852 0
+61 08 8302 1413
Fax 50852 0
Email 50852 0
james.dollman@unisa.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseRural Environments and Community Health (REACH): a randomised controlled trial protocol for an online walking intervention in rural adults.2014https://dx.doi.org/10.1186/1471-2458-14-969
N.B. These documents automatically identified may not have been verified by the study sponsor.