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Trial registered on ANZCTR


Registration number
ACTRN12616001189415
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
30/08/2016
Date last updated
30/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing menopausal symptoms and reducing chronic disease risk factors in midlife women: The Women's Wellness Program Study.
Scientific title
Efficacy of a women's wellness program for the reduction of menopausal symptoms and chronic disease risk factors in midlife women.
Secondary ID [1] 289888 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease 299836 0
Condition category
Condition code
Public Health 299755 299755 0 0
Health promotion/education
Reproductive Health and Childbirth 299887 299887 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 12 week structured multiple health behaviour change program (Women's Wellness Program) designed for midlife women. The intervention targets physical activity, nutrition, sleep and stress management. It incorporates health education and goal setting delivered through the Program Book, Website, and health consultations delivered by community based Registered Nurses (advanced practice > 5 years).
In this proof of concept study participants were allocated in blocks to one of three intervention groups/arms:
Arm A – independent unsupported online program, including
a. Hard copy of the program book and access to the e-book
b. Access to the Women’s Wellness Program website (weekly program content, activity planner, discussion board, podcasts)
c. Administrative and technical support for website issues and questions by email or phone;
Arm B - supported ‘face to face’ group program, including
a. Hard copy of the program book
b. Administrative support for appointment attendance and questions answered by email or phone
c. Attendance at a two hour health promotion group at QUT health clinics at 0, 4, 8 and 12 weeks facilitated by a registered nurse including health education and goal setting;
Arm C - supported ‘online’ program, including
a. Hard copy of the program book and access to the e-book
b. Access to the Women’s Wellness Program website (weekly program content, activity planner, discussion board, podcasts)
c. Administrative and technical support for website issues and questions by email or phone
d. Online ‘face to face’ 30-60 minute individual consultation with a registered nurse at 0, 4, 8 and 12 weeks, including health education and goal setting.

All participants were asked to access the program materials for 20-30 minutes daily in weeks 1-3. In weeks 4-12 participants were encouraged to use program materials regularly, at minimum twice a week for 30 minutes.
Strategies to monitor/encourage adherance included weekly diary of physical activity, fruit and vegetable intake; discussion during nurse consultation; online diary; online groups received weekly reminder text messages and emails regarding activity planning and diary activities.
Following the 12 week intervention period, participants retained printed and electronic books. Access to the website ceased following the 12 week intervention period.
Intervention code [1] 295563 0
Prevention
Intervention code [2] 295564 0
Lifestyle
Intervention code [3] 295565 0
Behaviour
Comparator / control treatment
Comparitor was Arm A, online independent group that received no nurse consultation.
Control group
Active

Outcomes
Primary outcome [1] 299211 0
Change in average menopausal symptoms within and between groups, measured by the Green Climacteric Scale.
Timepoint [1] 299211 0
Baseline and at 12 weeks after intervention commencement.
Primary outcome [2] 299212 0
Change in body mass index within and between groups measured by weight/height squared.
Timepoint [2] 299212 0
Baseline and 12 weeks after intervention commencement.
Secondary outcome [1] 326513 0
Change in physical activity within and between groups, measured by the Seattle Physical Activity Questionnaire.
Timepoint [1] 326513 0
Baseline and at 12 weeks after intervention commencement.
Secondary outcome [2] 326514 0
Change in fruit and vegetable intake within and between groups measured by items from the Food Frequency questionnaire.
Timepoint [2] 326514 0
Baseline and at 12 weeks after intervention commencement.
Secondary outcome [3] 326515 0
Change in perceived benefits and barriers to exercise within and between groups measured by the Exercise Benefits and Barriers Scale. (Composite outcome)
Timepoint [3] 326515 0
Baseline and at 12 weeks after intervention commencement.
Secondary outcome [4] 326516 0
Change in sleep quality and duration within and between groups measured by the General Sleep Disturbance Scale. (Composite outcome)
Timepoint [4] 326516 0
Baseline and at 12 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Female;
Aged between 40 to 65 years;
Able to speak, read and understand English;
Basic computer literacy (comfortable using a computer and keyboard including the internet and email) ;
Access to a personal computer or tablet device.
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self-reported illness or injury preventing vigorous exercise, for example: muscle or joint injury, severe arthritis, heart disease, cancer, and other illness;
Self-reported current mental health problem preventing commitment to a 12 week lifestyle program, for example: severe anxiety or major depression.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses performed using SPSS (Statistical Package for the Social Sciences) version 22. Descriptive data expressed as counts and percentages, and mean (SD), and inferential statistics performed using chi square tests, t-tests, Analysis of Covariance (ANCOVA) and linear mixed modelling. Effect size also calculated using Cohen's d standard formula to examine the magnitude of change in the three groups over the study period. Using Cohen’s guidelines an effect size of 0.20 as small, an effect size of 0.50 was moderate, and an effect size of 0.80 or more was considered to be a large.
Sample size was calculated based on the outcome measure of Body Mass Index (BMI). The average BMI for Australian women is 26kg/m2, with the BMI for Australian midlife women aged 45 -54 being a mean of 25.2 (SD4.8) and 55-64 years of 25.8 (SD4.7). A difference greater than a one unit difference on BMI is associated with a meaningful difference of a 12% reduction of the odds of healthy survival (95% confidence interval 10%-14%).
To achieve 80% power and a 95% confidence interval (a=0.05), the three study arms required 43 participants each, assuming a standard deviation of 4.8 and an observed difference of 2.4 units after the 12 week intervention. Allowing for 15% attrition over the 12 weeks of the study, it was planned that n=148 be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
31/07/2013
Date of last data collection
Anticipated
Actual
31/01/2014
Sample size
Target
148
Accrual to date
Final
225
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294255 0
University
Name [1] 294255 0
Queensland University of Technology Bluebox Proof of Concept Grant
Country [1] 294255 0
Australia
Primary sponsor type
University
Name
QUT Bluebox
Address
88 Musk Avenue
Kelvin Grove
Queensland, 4059
Country
Australia
Secondary sponsor category [1] 293087 0
None
Name [1] 293087 0
Address [1] 293087 0
Country [1] 293087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295678 0
Queensland University of Technology Human Research Ethics Committtee, NHMRC Registered Committee Number EC00171
Ethics committee address [1] 295678 0
Ethics committee country [1] 295678 0
Australia
Date submitted for ethics approval [1] 295678 0
03/12/2012
Approval date [1] 295678 0
21/03/2013
Ethics approval number [1] 295678 0
1300000048

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

Contacts
Principal investigator
Name 68114 0
Prof Debra Anderson
Address 68114 0
Current:
School of Nursing & Midwifery
Griffith University, Gold Coast Campus
Clinical Sciences 2 Building (G16)
Parklands Drive
Southport Qld 4215

Formerly:
School of Nursing
Queensland University of Technology
Kelvin Grove, QLD, 4059
Country 68114 0
Australia
Phone 68114 0
+61755528403
Fax 68114 0
Email 68114 0
[email protected]
Contact person for public queries
Name 68115 0
Debra Anderson
Address 68115 0
School of Nursing & Midwifery
Griffith University, Gold Coast Campus
Clinical Sciences 2 Building (G16)
Parklands Drive
Southport Qld 4215
Country 68115 0
Australia
Phone 68115 0
+61755528403
Fax 68115 0
Email 68115 0
[email protected]
Contact person for scientific queries
Name 68116 0
Debra Anderson
Address 68116 0
School of Nursing & Midwifery
Griffith University, Gold Coast Campus
Clinical Sciences 2 Building (G16)
Parklands Drive
Southport Qld 4215
Country 68116 0
Australia
Phone 68116 0
+61755528403
Fax 68116 0
Email 68116 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

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