Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000688583
Ethics application status
Approved
Date submitted
6/05/2024
Date registered
30/05/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
30/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Sleep Intervention for Improving Sleep and Lifestyle (Diet, Physical Activity and Sedentary Behaviour) in Women with Polycystic Ovary Syndrome
Scientific title
A Pilot Randomized Controlled Trial to Assess the Feasibility of a Sleep Cognitive Behavioural Therapy Intervention Compared to a Minimal Sleep Intervention for Improving Sleep and Lifestyle (Diet, Physical Activity and Sedentary Behaviour) Outcomes in Women with Polycystic Ovary Syndrome
Secondary ID [1] 312026 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SNAPS (Sleep, Nutrition and Activity in PCOS Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome (PCOS) 333632 0
Condition category
Condition code
Public Health 330319 330319 0 0
Health promotion/education
Reproductive Health and Childbirth 330450 330450 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pragmatic Randomised Controlled Trial (RCT) that will evaluate the feasibility of a sleep cognitive behavioural therapy (CBT) intervention compared to a minimal intervention control in real-life routine practice conditions without intervening with participants usual care or treatment. Participants are required to commit for a total of 13-weeks throughout the duration of the study. The trial will recruit n = 40 participants with PCOS who attend the Monash Health PCOS clinic and be randomised into either the sleep CBT intervention group (n = 20) or the minimal intervention control group (n = 20). The sleep CBT intervention will be administered by trained healthcare professionals such as accredited practising Dietitians.

The sleep CBT intervention groups comprise of Intervention A group (In-person intervention delivery with the option of over-the-phone) or Intervention B group (remote online delivery only). Depending on where the participant lives, if they live in Melbourne, they will be assigned to Intervention A group as this requires them to attend some of the sessions face-to-face at Monash University and some sessions online via telehealth (Zoom) or over-the-phone with the research team. If the participant lives outside of Melbourne (within Australia), they will be assigned to Intervention B group as this requires them to attend all sessions remotely online via telehealth (Zoom) or over-the-phone.

Research activities for the Intervention A or B groups:
I) Routine collected data from medical records: All Intervention groups will have their routine collected data from PCOS clinic Monash Health medical records retrieved by the research team to assess PCOS diagnosis, anthropometric data, clinical and biochemical data. Baseline blood samples will be collected from the PCOS clinic as part of routine care and the following hormones are of interest: prolactin, 17-oh-progesterone, Thyroid Stimulating Hormone, Follicular Stimulating Hormone, Luteinizing Hormone, biochemical hyperandrogenism (Testosterone, sex hormone binding globulin (SHBG)).
ii) Menstrual cyclicity: All intervention groups will be asked to retrospectively report for 3 months their menses using a menses calendar and track their cycle throughout the study. Participants will be given the option to complete the menses calendar online or in hard copy.
iii) Sleep quality and quantity: Actigraphy (Actiwatch Spectrum Pro, Phillips) will only be given to the Intervention A group in-between study sessions. Participants to worn for 7 days and used to collect actigraphy data. To aid data cleaning the participants will also complete a 7-day sleep diary.
iv) Sleep CBT intervention: The sleep CBT intervention will be based on capability, opportunity and motivation–behaviour (COM-B) principles to support behaviour change for the participant (and bed partner if applicable) (1). This will be based on promoting healthy sleep practices delivered through four one-to-one over-the-phone or telehealth personalised sessions for 30-35 minutes each session at 0 (i.e., baseline), 2, 6, 10-12 weeks, followed up by a sheet to take home with a summary of the discussion. It will discuss in non-scientific terms the importance of sleep for overall health and wellbeing and the link between sleep, lifestyle, diet and chronic disease. There will be core components of the intervention including i) stimulus control, ii) encouraging a balanced attitude to sleep and iii) dealing with night-time worries. These will be provided in a stepwise approach through the intervention sessions. Elective components that can be selected from the Centre for Clinical Investigation Sleep Information sheet (2) and sleep support in isolation from Monash and Stanford Universities (3). These information sheets will be used as a basis of self-selecting sleep goals to drive behaviour change. Goals will be formulated according to SMART (specific, measurement, achievable, relevant and time-limited) principles. Weekly personalised and generic text messages (for 12-weeks) with tips about sleep behaviour will also be sent to the participant relating to goals set at intervention meeting.
v) Survey questionnaires: Online questionnaires on demographics, sleep, diet, mental health, quality of life, physical activity will be provided to all participants in the intervention groups upon enrolment into the study and during several visit study timepoints and where possible will be completed and returned to the researcher on the same day. Participants will be provided the option to complete these questionnaires in hard copy or electronically.
vi) Semi-structured interviews: Exit interview and (optional) focus group discussions at the end of trial to identify barriers and enablers to the sleep CBT intervention goals and to test the feasibility of the intervention. Behaviour change wheel of COM-B model will be explored during goal setting.

For intervention A group (Sleep CBT intervention delivery in-person or over-the-phone):
Participants will be asked to attend five study visits with the research team that includes two face-to-face and three over-the-phone or online via telehealth Zoom meetings at week-0 (for 2 to 3 hours), week-2 (for 30-35 minutes), week-6 (for 2 to 3 hours), week-10 to 12 (for 30-35 minutes), and week-13 (for 2 to 3 hours). Four out of five of these study visits will involve sleep CBT intervention consultation sessions by trained health professionals like Dietitians for 30-35 minutes per session at 0, 2, 6, 10-12 weeks. Participants will also receive weekly text messages for 12-weeks with tips about sleep behaviour relating to goals set at intervention sessions. Other study assessments will be administered by the research team that include sleep actigraphy (Actiwatch device) with sleep diary and survey questionnaires on demographics, sleep, diet, mental health, quality of life, physical activity, and menstrual cyclicity. The Actiwatch device may also be given out to the participants in-between study visits. An exit interview and (optional) focus group discussions at the end of trial administered by trained health professionals and/or study researchers, will identify barriers and enablers to the sleep CBT intervention goals and to test the feasibility of the intervention. Behaviour change wheel of COM-B model will be explored during goal setting. The estimated total time commitment to complete all study assessments (10 hours) and intervention delivery (3 hours) is 13 hours.

For intervention B group (Sleep CBT intervention delivery remote online):
There will be no in-person and sleep actigraphy measurements. All other data collection measures will be the same as per Intervention A group above, but will be administered online. Participants will be asked to attend five study visits with the research team over-the-phone or online via telehealth Zoom meetings at week-0 (for 2 to 3 hours), week-2 (for 30-35 minutes), week-6 (for 2 to 3 hours), week-10 to 12 (for 30-35 minutes), and week-13 (for 2 to 3 hours). Four out of five of these study visits will involve remote online sleep intervention consultation sessions by trained health professionals like Dietitians for 30-35 minutes per session at 0, 2, 6, 10-12 weeks. Participants will also receive weekly text messages for 12-weeks with tips about sleep behaviour relating to goals set at intervention sessions. Other study assessments will be administered by the research team that include survey questionnaires about demographics, sleep, diet, mental health, quality of life, physical activity, and menstrual cyclicity. An exit interview and (optional) focus group discussions at the end of trial administered by trained health professionals and/or study researchers, will identify barriers and enablers to the sleep CBT intervention goals and to test the feasibility of the intervention. Behaviour change wheel of COM-B model will be explored during goal setting. The estimated total time commitment to complete all study assessments (10 hours) and intervention delivery (3 hours) is 13 hours.

No specific training is needed prior to the first participant enrolment. since health professionals (Dietitians) involve in this study are qualified researchers with the skills and knowledge required to administer the sleep-CBT intervention and provide support during the study assessments.

Strategies used to monitor adherence to the intervention include using feasibility checklists for researchers to track at each study timepoint. These feasibility (intervention and text messages) checklists will capture participants completion of intervention components delivered by health professionals. At each intervention meeting, the health professional will discuss with the participant, their ability to adhere to the goals set in the previous session and explore any barriers and enablers.

References:
(1) Michie S, Van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implementation science. 2011;6(1):1-12.
(2) Centre for Clinical Interventions. Sleep Hygiene Centre for Clinical Interventions. doi:https://www.cci.health.wa.gov.au/~/media/CCI/Mental-Health-Professionals/Sleep/Sleep---Information-Sheets/Sleep-Information-Sheet---04---Sleep-Hygiene.pdf Accessed 12 August 2023.
(3) Bei B RS, Drummond S, Manber R. Sleeping tips when staying indoors during isolation period 2020. doi:https://github.com/beisci/SleepInfo/blob/master/sleep_in_isolation.md Accessed 12 August 2023.
Intervention code [1] 328475 0
Treatment: Other
Comparator / control treatment
The minimal intervention control group comprise of Control C (In-person intervention delivery with the option of over-the-phone) or Control D group (remote online delivery only) depending on where the participant lives. The control group will receive the minimal intervention which involves our research team handing out flyers in-person or via email respectively that contain information about sleep and good sleep quality to participants.

For Control C group (Minimal intervention in-person or over-the-phone), all data collection measures will be the same as per intervention A group. For Control D group (Minimal intervention remote online), all data collection measures will be the same as per intervention B group.
Control group
Active

Outcomes
Primary outcome [1] 338093 0
Acceptability
Timepoint [1] 338093 0
Following end of intervention (13-week)
Primary outcome [2] 338094 0
Implementation
Timepoint [2] 338094 0
Following end of intervention (13-week)
Primary outcome [3] 338095 0
Limited efficacy (composite primary outcome)
Timepoint [3] 338095 0
i) Sleep measures will be assessed at baseline (week 0), mid (week 6) and at the end (week 13) of the intervention. Actigraphy will be assessed at baseline (week 0) and end (week 13) of the intervention.
ii) Dietary intake will be assessed at baseline, week 6 and at the conclusion (week 13) of the intervention.
iii) Physical activity will be assessed at baseline, week 6 and the conclusion (week 13) of the intervention.
iv) Psychological factors will be assessed at baseline, week 6 and at the conclusion (week 13) of the intervention.
v) Menstrual cyclicity will be measured at baseline, week 6 and at the conclusion (week 13) of the intervention.
Secondary outcome [1] 434521 0
Practicality (Primary outcome)
Timepoint [1] 434521 0
Following end of intervention (13-week)
Secondary outcome [2] 435012 0
Demand (Primary outcome)
Timepoint [2] 435012 0
Following end of intervention (13-week)
Secondary outcome [3] 435013 0
Barriers and enablers to implementing behavioural lifestyle change (composite secondary outcome)
Timepoint [3] 435013 0
Following end of intervention (13-week)

Eligibility
Key inclusion criteria
For Intervention A group:
Women aged 18-45, have a diagnosis of PCOS, live in Melbourne, not co-sleeping with children, with poor sleep quality (Pittsburgh Sleep Quality Index, global PSQI score>5), have no clinical or have subthreshold insomnia (Insomnia Severity Index, ISI score <15) and/or low risk of sleep apnea (Berlin Questionnaire, only 1 or no categories where the BQ score is positive), using medication for psychological or mental health conditions, using hormonal contraceptives/insulin sensitizers, and with normal/mild/moderate/severe scores for depression, anxiety and/or stress from the Depression Anxiety Stress Scales (DASS-21) questionnaire.

For Intervention B group:
Inclusion criteria are the same as per intervention A above, except that participants in this group live outside of Melbourne (within Australia).

For Control C group:
Inclusion criteria are the same as per intervention A above.

For Control D group:
Inclusion criteria are the same as per intervention B above.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
For Intervention A group:
Women who are pregnant, live outside of Melbourne, actively trying to conceive or breastfeeding, co-sleeping with children, reproductive disorders other than PCOS, implanted cardiac devices, any history of clinical sleep conditions based on medical histories (obstructive sleep apnoea, insomnia, narcolepsy or circadian rhythm disorders), type 2 diabetes or other chronic illness that may affect study outcomes, shift workers (determined based on work schedules where working hours fall between 10:00 pm - 6:00 am), with good sleep as measured through the PSQI global score <=5, with clinical (moderate severity/severe) insomnia (ISI score >=15) and/or high risk of sleep apnea (2 or more categories where the BQ score is positive), and extremely severe scores for depression, anxiety and/or stress from the DASS-21 questionnaire.

For Intervention B group:
Exclusion criteria are the same as per intervention A above, except that participants in this group live outside of Melbourne (within Australia).

For Control C group:
Exclusion criteria are the same as per intervention A above.

For Control D group:
Exclusion criteria are the same as per intervention B above.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using computer by another staff member (not intervention provider)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer-generation of a randomisation sequence
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
As this pilot study aims to test the feasibility of a sleep CBT intervention for improving sleep and lifestyle in women with PCOS, and inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial, no formal hypothesis testing is required. As this is a pilot study, the level of missing data will be documented but no imputation will be undertaken, and no statistical power calculation will be taken. Any interpreted P-values in this pilot study should be with a disclaimer that the study is not adequately powered; and while post hoc power calculations are possible, they are generally not advisable. Instead, descriptive statistics, estimation and confidence intervals will be used to infer the size and direction of intervention effect.

Analyses was undertaken using the statistical software SPSS or STATA. Linear mixed models will be used to assess the association of randomisation, time and their interaction. Surveys will be analysed using descriptive statistics and t-tests. Potential confounders such as socio-demographic variables (e.g., ethnicity, socioeconomic status) and others (e.g., BMI, age) will be collected at baseline and adjust accordingly in the data analysis. We will analyse quantitative data as descriptive with outcomes being interval estimates of variables, relating to feasibility. For qualitative data, all interviews will be audio recorded and transcribed verbatim using professional transcription services. Transcripts will be analysed by 2 people and coded into themes using NVivo and mapped onto the Bowen feasibility framework or COM-B and Theoretical Domains Framework (TDF) frameworks.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26485 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 42475 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 316377 0
Government body
Name [1] 316377 0
National Health and Medical Research Council (NHMRC) Polycystic Ovary Syndrome Centre for Research Excellence
Country [1] 316377 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318573 0
None
Name [1] 318573 0
Address [1] 318573 0
Country [1] 318573 0
Other collaborator category [1] 283017 0
University
Name [1] 283017 0
Monash Centre for Health Research and Implementation (MCHRI)
Address [1] 283017 0
Country [1] 283017 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315185 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315185 0
Ethics committee country [1] 315185 0
Australia
Date submitted for ethics approval [1] 315185 0
19/02/2024
Approval date [1] 315185 0
08/07/2024
Ethics approval number [1] 315185 0
RES-24-0000-139A

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

Contacts
Principal investigator
Name 133922 0
Dr Christie Bennett
Address 133922 0
Monash University, Be Active Sleep Eat (BASE) Facility, Department of Nutrition, Dietetics and Food, Faculty of Medicine, Nursing and Health Sciences, 264 Ferntree Gully Rd, Notting Hill, Victoria, 3168
Country 133922 0
Australia
Phone 133922 0
+61 3 9905 3951
Fax 133922 0
Email 133922 0
Christie.Bennett@monash.edu
Contact person for public queries
Name 133923 0
Christie Bennett
Address 133923 0
Monash University, Be Active Sleep Eat (BASE) Facility, Department of Nutrition, Dietetics and Food, Faculty of Medicine, Nursing and Health Sciences, 264 Ferntree Gully Rd, Notting Hill, Victoria, 3168
Country 133923 0
Australia
Phone 133923 0
+61 3 9905 3951
Fax 133923 0
Email 133923 0
Christie.Bennett@monash.edu
Contact person for scientific queries
Name 133924 0
Christie Bennett
Address 133924 0
Monash University, Be Active Sleep Eat (BASE) Facility, Department of Nutrition, Dietetics and Food, Faculty of Medicine, Nursing and Health Sciences, 264 Ferntree Gully Rd, Notting Hill, Victoria, 3168
Country 133924 0
Australia
Phone 133924 0
+61 3 9905 3951
Fax 133924 0
Email 133924 0
Christie.Bennett@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All participants de-identified grouped data that have been collected in the trial
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigators (Dr Christie Bennett; Email: christie.bennett@monash.edu or Associate Professor Lisa Moran; Email: lisa.moran@monash.edu)


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.