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Trial registered on ANZCTR


Registration number
ACTRN12616001154493
Ethics application status
Approved
Date submitted
22/08/2016
Date registered
25/08/2016
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Date results provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Women's Wellness Program: An e-Health lifestyle intervention for mid-life women living with type2 diabetes
Scientific title
Women's Wellness with Type 2 Diabetes: A 12 week lifestyle intervention to improve health related quality of life for mid-life women with type 2 diabetes
Secondary ID [1] 289987 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 299992 0
Condition category
Condition code
Metabolic and Endocrine 299885 299885 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week e-health lifestyle intervention, focusing on living well with type 2 diabetes for mid life and beyond females. (incorporating diet management, appropriate individually tailored exercise, management of menopausal and other symptoms associated with midlife and beyond.) 3 virtual consultations with an experienced nurse and access to a specifically designed web-site, I-Book and hard copy book. On assessment for eligibility for the study participants receive access to a specifically designed web site with information relating to type 2 diabetes, podcasts, discussion board and news board. They are also able to record their biophysical measurement, activity, and dietary and other changes on a secure. site. each participant has three consultations with an experienced clinical nurse at baseline, week 6 and week 12 as a minimum to assess individual need around management of appropriate diet and exercise and provide strategies for developing positive changed behaviour. To encourage adherence participants will receive email contact at week 3 and 9. Each participant is provided with a hard copy book incorporating information around diabetes management and wellness (developed in conjunction with diabetes Queensland and Kings College London and based on previous Women's Wellness materials - Women's Wellness after Cancer Program and Younger Women's Wellness after Cancer Program). The program incorporating all three elements described is a stepwise approach over the 12 week period.
Intervention adherence is assed through consultations with the clinical nurse and data collection points by the research assistant at weeks 0 and weeks 12.
Intervention code [1] 295685 0
Lifestyle
Intervention code [2] 295707 0
Behaviour
Intervention code [3] 295708 0
Treatment: Other
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299365 0
Health related quality of life using SF36 v2
Timepoint [1] 299365 0
Baseline and 12 weeks
Secondary outcome [1] 326942 0
Change in BMI through biophysical measures,
Timepoint [1] 326942 0
Baseline and 12 weeks
Secondary outcome [2] 326943 0
change in physical activity measured through International Physical activity Questionnaire (IPAQ)
Timepoint [2] 326943 0
baseline and 12 weeks
Secondary outcome [3] 326944 0
management of diabetes self efficacy measured through Diabetes Self Efficacy Scale
Timepoint [3] 326944 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
Australian and UK residents
Females
Diagnosed with type 2 Diabetes
Able to speak and read English
Own or has access to a computer or I-Pad tablet device
Computer literate
Has internet service at home address
Own or has access to body weight scale
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes
Any clinical, cognitive or psychiatric contraindications identified by treating staff

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Calculation for the feasibility study is 90 participants through G power, The study will also provide initial parameter estimates for the primary endpoint (HRQoL) from which sample size calculations can be performed for sufficient power for a larger RCT. Descriptive statistics will collect measures and participant characteristics and will also explore trends in the data over time. Collection of data is via on-line survey and research assistant measures. Data will be downloaded into IBM SPSS following completion of data collection week 12 for analysis. Measures used: SF36v2; self reported weight and height. Greene Climacteric Scale (GCS); Pittsburgh, Sleep Quality Index (PSQI); Diabetes Management Self Efficacy Scale (DMSES20). Diabetes Distress Scale, Food Frequency Questionnaire (FFQ) and International Physical Activity Questionnaire (IPAQ).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2016
Actual
2/09/2016
Date of last participant enrolment
Anticipated
1/03/2017
Actual
28/08/2017
Date of last data collection
Anticipated
30/06/2017
Actual
20/12/2017
Sample size
Target
90
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 8118 0
United Kingdom
State/province [1] 8118 0
london

Funding & Sponsors
Funding source category [1] 294358 0
Charities/Societies/Foundations
Name [1] 294358 0
Diabetes Queensland
Country [1] 294358 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University / Menzies Health Institute
School of Nursing and Midwifery
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
Country
Australia
Secondary sponsor category [1] 293199 0
None
Name [1] 293199 0
Address [1] 293199 0
Country [1] 293199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295776 0
HREC Griffith University
Ethics committee address [1] 295776 0
Ethics committee country [1] 295776 0
Australia
Date submitted for ethics approval [1] 295776 0
10/11/2015
Approval date [1] 295776 0
03/06/2016
Ethics approval number [1] 295776 0
2016/074

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

Contacts
Principal investigator
Name 68438 0
Prof Debra Anderson
Address 68438 0
School of Nursing and Midwifery
G16 Clinical Sciences
Griffith University
Parklands Drive
Southport
Queensland 4222
Country 68438 0
Australia
Phone 68438 0
+61 7 5552 8403
Fax 68438 0
Email 68438 0
debra.anderson@griffith.edu.au
Contact person for public queries
Name 68439 0
Nicole McDonald
Address 68439 0
Room1..32 Block L.08
Griffith University
Logan Campus
University Drive
Meadowbrook
Queensland 4131
Country 68439 0
Australia
Phone 68439 0
+61 7 3382 1407
Fax 68439 0
Email 68439 0
n.mcdonald@griffith.edu.au
Contact person for scientific queries
Name 68440 0
Debra Anderson
Address 68440 0
School of Nursing and Midwifery
G16 Clinical Sciences
Griffith University
Parklands Drive
Southport
Queensland 4222
Country 68440 0
Australia
Phone 68440 0
+61 7 5552 8403
Fax 68440 0
Email 68440 0
debra.anderson@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this was a feasibility study, we aim to conduct a larger trial to confirm the findings


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.