Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001641280
Ethics application status
Approved
Date submitted
27/09/2018
Date registered
4/10/2018
Date last updated
4/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The GroWell for Health Program Pilot Study
Scientific title
A nurse led behaviour change intervention for the prevention of chronic disease in midlife adults: the 'GroWell for Health Program' pilot study.
Secondary ID [1] 296190 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease 309823 0
Cardiovascular disease 309861 0
Type 2 diabetes 309862 0
Condition category
Condition code
Public Health 308614 308614 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A
Receive a complex 8 week behaviour change intervention targeting modifiable risk factors for chronic disease including: physical activity, diet, alcohol intake, smoking, stress and psychological well-being and risk screening behaviours.
The Program is based on the transtheoretical model of behaviour change and incorporates motivational themes and messages, activities and goal setting to reduce barriers to behaviour change.
All participants will recieve a GroWell for Health Program e-book (interactive PDF) containing evidence based health information and structured step by step guide to support behaviour change. The Program contains weekly readings and activities around different health topics. For example, week 2 activities include reflecting on current dietary habits, motivation for change and goal setting/planning for the week ahead. The interactive eBook allows entry of text to enable self-monitoring of behaviour.
Arm A participants will undertake the Program independently over an 8 week period.
Participants undertake the Program in their community/home setting.
Intervention code [1] 312513 0
Prevention
Intervention code [2] 312514 0
Lifestyle
Intervention code [3] 312515 0
Behaviour
Comparator / control treatment
Arm B
Receive a complex 8 week behaviour change intervention targeting modifiable risk factors for chronic disease including: physical activity, diet, alcohol intake, smoking, stress and psychological well-being and risk screening behaviours.
The Program is based on the transtheoretical model of behaviour change and incorporates motivational themes and messages, activities and goal setting to reduce barriers to behaviour change.
All participants will recieve a GroWell for Health Program e-book (interactive PDF) containing evidence based health information and structured step by step guide to support behaviour change. The Program contains weekly readings and activities around different health topics. For example, week 2 activities include reflecting on current dietary habits, motivation for change and goal setting/planning for the week ahead. The interactive eBook allows entry of text to enable self-monitoring of behaviour.
Arm B participants will undertake the Program with the addition of nurse coaching delivered by experienced Registered Nurses, using principles of motivational interviewing and goal setting to support behaviour change.
Three online consultation are delivered via Skype/Facetime at: Baseline 0 Weeks (1 hour), 4 weeks (30 minutes) and 8 weeks (30 mintues).
Participants undertake the Program in their community/home setting.
Control group
Active

Outcomes
Primary outcome [1] 307577 0
Feasibility of program delivery.
This includes a process evaluation through analysis of qualitative feedback from both participants and program staff about strengths and weaknesses in recruitment, intervention delivery and data collection strategies, to evaluate what changes/improvements need to be made in preparation for a larger study.
Data is collected from study participants via online questionnaire (Time 2) and short semi-structured exit interviews. Questions are designed specifically for this study.
Study staff will make written records of any issues as they arise, discuss during regular team meetings and participate in final SWOT analysis at the end of pilot study.
Timepoint [1] 307577 0
8 weeks post enrolment (Time 2)
Primary outcome [2] 307612 0
Utility and acceptability of the program e-Book and nurse coaching.
Qualitative feedback will be sought from both participants and program staff about ease of use of the program book, book content and format, online consultations, strengths and weaknesses and suggestions for improvement.
Data will be collected via online questionnaire (Time 2) and short semi-structured exit interviews with participants. Questions are designed specifically for this study.
Study staff will make written records of any issues as they arise, discuss during regular team meetings and participate in final SWOT analysis at the end of pilot study.
Timepoint [2] 307612 0
8 weeks post enrolment (Time 2)
Secondary outcome [1] 352353 0
Physical activity level (IPAQ Short Form)
Timepoint [1] 352353 0
On enrollment (T1), 8 weeks post enrollment (T2) and 8 weeks post program (T3)
Change over time
Secondary outcome [2] 352354 0
Daily serves of fruit
(Items from the National Nutrition and Physical Activity Survey Questionnaire)
Timepoint [2] 352354 0
On enrollment (T1), 8 weeks post enrollment (T2) and 8 weeks post program (T3)
Change over time
Secondary outcome [3] 352471 0
Daily serves of vegetables
(Items from the National Nutrition and Physical Activity Survey Questionnaire)
Timepoint [3] 352471 0
On enrollment (T1), 8 weeks post enrollment (T2) and 8 weeks post program (T3)
Change over time
Secondary outcome [4] 352472 0
Health related quality of life (SF12v2)
Timepoint [4] 352472 0
On enrollment (T1), 8 weeks post enrollment (T2) and 8 weeks post program (T3)
Change over time

Eligibility
Key inclusion criteria
- Adults
- Able to speak and read Level 10 English
- Access to a mobile, tablet or eReader device
Minimum age
40 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Exisiting diagnosis of cardiovascular disease, type 2 diabetes or cancer in the past 12 months
- Signs and symptoms of underlying disease, or who may be at higher risk of an adverse event during exercise
- Any clinical, cognitive or psychaitric contraindication identified by clinical staff

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 by research assistant not delivering intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, stratified random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This pilot study is not powered to evaluate efficacy, nor is there a true control group.
However descriptive and inferential statistical analysis will be undertaken preliminary measures of efficacy and to inform sample size calculations and study design of future larger study.
Qualitative methods are used to evaluate participant feedback about utility, acceptability, data collection processes and study procedures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/10/2018
Actual
Date of last participant enrolment
Anticipated
14/12/2018
Actual
Date of last data collection
Anticipated
12/04/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 24177 0
4222 - Griffith University

Funding & Sponsors
Funding source category [1] 300780 0
University
Name [1] 300780 0
Griffith University
Country [1] 300780 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Menzies Health Institute Queensland
Address
59 Parklands Drive
Southport QLD 4222
Country
Australia
Secondary sponsor category [1] 300327 0
None
Name [1] 300327 0
None
Address [1] 300327 0
None
Country [1] 300327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301563 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 301563 0
170 Kessels Road
Nathan QLD 4111
Ethics committee country [1] 301563 0
Australia
Date submitted for ethics approval [1] 301563 0
Approval date [1] 301563 0
28/03/2018
Ethics approval number [1] 301563 0
2018/259

Summary
Brief summary
The research project will aim to establish the utility and acceptability of the GroWell for Health Program, a novel self-directed eight week eHealth multiple health behaviour change intervention tailored for midlife adults. The research design is a pre-test, post-test trial and will be conducted with 60 men and women aged 40 to 59 years without any existing diagnosis of cardiovascular disease, type 2 diabetes or cancer in the past 12 months. Each participants will be allocated to either Intervention Group A (Program independent) or Intervention Group B (Program + virtual nurse coaching), where the intervention will be delivered accordingly. Baseline (0 weeks), post-intervention (8 weeks) and follow-up (16 weeks) data will be collected from all participants via an online survey and a virtual appointment. Participants in Intervention Group A will also partake in a short qualitative semi-structured questionnaire to provide feedback about the program delivery.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3115 3115 0 0
/AnzctrAttachments/376085-Griffith University - Staff Mail - Your Human Ethics Protocol 2018_259 has been Fully approved.pdf (Ethics approval)

Contacts
Principal investigator
Name 87398 0
Dr Amanda McGuire
Address 87398 0
Menzies Health Institute Queensland
Griffith University
59 Parklands Drive
Southport, QLD, 4222
Country 87398 0
Australia
Phone 87398 0
+61 7 5552 8860
Fax 87398 0
Email 87398 0
[email protected]
Contact person for public queries
Name 87399 0
Dr Amanda McGuire
Address 87399 0
Menzies Health Institute Queensland
Griffith University
59 Parklands Drive
Southport, QLD, 4222
Country 87399 0
Australia
Phone 87399 0
+61 7 5552 8860
Fax 87399 0
Email 87399 0
[email protected]
Contact person for scientific queries
Name 87400 0
Dr Amanda McGuire
Address 87400 0
Menzies Health Institute Queensland
Griffith University
59 Parklands Drive
Southport, QLD, 4222
Country 87400 0
Australia
Phone 87400 0
+61 7 5552 8860
Fax 87400 0
Email 87400 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.