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Trial registered on ANZCTR


Registration number
ACTRN12616001462471
Ethics application status
Approved
Date submitted
12/10/2016
Date registered
19/10/2016
Date last updated
28/10/2019
Date data sharing statement initially provided
28/10/2019
Date results information initially provided
28/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The SEED Project (Sleep, Eat, Emotions, and Development): Enhancing sleep and wellbeing in mothers and infants.
Scientific title
The SEED Project (Sleep, Eat, Emotions, and Development): A randomized controlled pilot study of a perinatal sleep intervention on sleep and wellbeing in mothers and infants.
Secondary ID [1] 290305 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
SEED (Sleep, Eat, Emotions, and Development)
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 300554 0
Insomnia 300586 0
Mood disturbance 300588 0
Condition category
Condition code
Reproductive Health and Childbirth 300440 300440 0 0
Normal pregnancy
Mental Health 300441 300441 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A summary of the Sleep SEED core content is as follows:
a) general information and skills for better sleep (e.g., typical sleep patterns of new parents and infants, sleep hygiene, relaxation and mindfulness exercise, dealing with nighttime worries);
b) fostering healthy attitudes and expectations about sleep during perinatal periods;
c) managing sleep challenges specific to perinatal period (e.g., physical discomfort, pain, sleep deprivation, daytime consequences of poor sleep);
d) infant sleep and settling skills;
e) identifying and managing symptoms of insomnia (e.g., self-monitoring, stimulus control, sleep scheduling, bed restriction).

At program entry, participants will receive a one-on-one program orientation (up to 1 hour) via telephone (recorded for quality control) by a registered psychologist or clinical psychology trainee under regular supervision of a registered clinical psychologist. The individual delivering the orientation will be trained by the chief investigator to follow pre-scripted protocol, which covers the following aspects:
a) overview and rationale of the program, including an introduction to the program's core principles (e.g., cognitive behavioral principles), an overview of topics covered, and introduction to the core components;
b) structure of the program and logistics;
c) importance of practice and regular strategies.

Following the program orientation, participants will receive intervention materials via emails at 6 different time points:
T1: 26-32 weeks gestation
T2: 35-36 weeks gestation
T3: 2 weeks postpartum
T4: 1.5 months postpartum
T5: 3 months postpartum
T6: 6 months postpartum

The intervention materials are tailored to, and delivered at, critical perinatal milestones that have specific challenges to sleep (e.g., physical discomfort in late pregnancy). The emails will contain text, graphics, and audio download links on relevant information. Adherence to the intervention is assessed after each intervention phase via self-report surveys.

If participants require additional information or support with the program, telephone consultation will be available from a clinical psychologist.
Intervention code [1] 296111 0
Behaviour
Intervention code [2] 296149 0
Prevention
Comparator / control treatment
Diet SEED has been adapted from the current consumer information fact sheets at the Royal Women's Hospital, in Melbourne, Australia.

A summary of the Diet SEED core content is as follows:
a) Nutrient required in greater amounts during the third trimester of pregnancy;
b) Symptoms that can become more severe towards the end of pregnancy, getting organised for the birth, and bringing a new baby home;
c) Nutrition for breast-feeding;
d) Weight management;
e) Introducing solid food for the baby;
f) Family eating.

At program entry, participants will receive a one-on-one program orientation via telephone (up to 1 hour, recorded for quality control) by a dietician, which covers the following aspects:
a) overview and rationale of the program, including an introduction to the program's core principles (e.g., cognitive behavioral principles), an overview of topics covered, and introduction to the core components;
b) structure of the program and logistics;
c) importance of practice and regular strategies.

Following the program orientation, participants will receive intervention materials via emails at 6 different time points:
T1: 26-32 weeks gestation
T2: 35-36 weeks gestation
T3: 2 weeks postpartum
T4: 1.5 months postpartum
T5: 3 months postpartum
T6: 6 months postpartum

The intervention materials are tailored to, and delivered at, critical perinatal milestones for diet (e.g., nutrient requirement in late pregnancy). Content will be delivered in a combination of text, graphics, and links to external nutrition guidelines. Adherence to the intervention is assessed after each intervention phase via self-report surveys.

If participants require additional information or support with the program, telephone consultation will be available from a dietitian.
Control group
Active

Outcomes
Primary outcome [1] 299854 0
Maternal sleep quality will be assessed using a) self-reported sleep behaviors over the past week (Carney et al., 2012), and b) PROMIS Sleep Disturbance instrument (Yu et al., 2012).
Timepoint [1] 299854 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T2: 35-36 weeks gestation (I week after intervention materials)
T4: 1.5 months postpartum (I week after intervention materials)
T5: 3 months postpartum (I week after intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Primary outcome [2] 299855 0
Symptoms of insomnia will be measured using Insomnia Severity Index (Bastien, Vallieres, & Morin, 2001), and the Insomnia module of the Duke Structured Interview for Sleep Disorders (Edinger et al., 2009).
Timepoint [2] 299855 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T2: 35-36 weeks gestation (I week after intervention materials)
T4: 1.5 months postpartum (I week after intervention materials)
T5: 3 months postpartum (I week after intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Primary outcome [3] 299856 0
Feasibility of the program and acceptability to patients (composite outcome) will be assessed implicitly via recruitment/dropout rates, and explicitly via the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982) and qualitative feedback in post-intervention questionnaires from patients.
Timepoint [3] 299856 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Secondary outcome [1] 328320 0
Maternal sleep-rated impairment will be assessed using PROMIS Sleep Related Impairment
Timepoint [1] 328320 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T2: 35-36 weeks gestation (I week after intervention materials)
T4: 1.5 months postpartum (I week after intervention materials)
T5: 3 months postpartum (I week after intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Secondary outcome [2] 328321 0
Maternal mental health will be measured with PROMIS Depression and Anxiety
Timepoint [2] 328321 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T2: 35-36 weeks gestation (I week after intervention materials)
T4: 1.5 months postpartum (I week after intervention materials)
T5: 3 months postpartum (I week after intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Secondary outcome [3] 328322 0
Maternal health-related quality of life will be assessed by EQ-5D-5L
Timepoint [3] 328322 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T2: 35-36 weeks gestation (I week after intervention materials)
T4: 1.5 months postpartum (I week after intervention materials)
T5: 3 months postpartum (I week after intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Secondary outcome [4] 328323 0
Relationship satisfaction will be assessed using the brief Dyadic Adjustment Scale
Timepoint [4] 328323 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T2: 35-36 weeks gestation (I week after intervention materials)
T4: 1.5 months postpartum (I week after intervention materials)
T5: 3 months postpartum (I week after intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Secondary outcome [5] 328324 0
Attachment quality will be measured with the a) Prenatal Attachment Inventory, b) the Mother to Infant Bonding Scale, and c) the Emotional Availability Scale (free play video).
Timepoint [5] 328324 0
T1: 26-32 weeks gestation (Immediately before intervention materials) - a) only
T2: 35-36 weeks gestation (I week after intervention materials) - a) only
T4: 1.5 months postpartum (I week after intervention materials) - b) only
T5: 3 months postpartum (I week after intervention materials) - b) only
T6: 6 months postpartum (I week after intervention materials) - b) and c)
Secondary outcome [6] 328411 0
Dietary intake (this is an exploratory aim) of the mother will be assessed using Australian Eating Survey,
Timepoint [6] 328411 0
T1: 26-32 weeks gestation (Immediately before intervention materials)
T6: 6 months postpartum (I week after intervention materials)
Secondary outcome [7] 328486 0
Weight status (also an exploratory aim associated the diet intervention), including
BMI, gestational weight gain, postpartum weight retention will be measured using self-reported a) weight and b) height.
Timepoint [7] 328486 0
T1: 26-32 weeks gestation (Immediately before intervention materials) - a) and b)
T2: 35-36 weeks gestation (I week after intervention materials) - a) only
T4: 1.5 months postpartum (I week after intervention materials) - a) only
T5: 3 months postpartum (I week after intervention materials) - a) only
T6: 6 months postpartum (I week after intervention materials) - a) only
Secondary outcome [8] 351834 0
Symptoms of insomnia will be measured using Insomnia Severity Index (Bastien, Vallieres, & Morin, 2001), and the Insomnia module of the Duke Structured Interview for Sleep Disorders (Edinger et al., 2009).
Timepoint [8] 351834 0
1 and 2 years postpartum.

Eligibility
Key inclusion criteria
a) Nulliparous (first time mothers);
b) Age >= 18;
c) Singleton pregnancy;
d) Able to understand intervention materials in English and complete surveys in English;
e) Have regular accessing to email and internet.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Participants who use medication or substances that directly affect sleep;
b) Unstable medical conditions that directly affect sleep;
c) Participants who show the following symptoms of sleep disturbance: sleep apnea, previously diagnosed Periodic Limb Movement Disorder, Restless Legs Syndrome;
d) Circadian rhythm disorders (based on DUKE): Irregular Sleep Wake Disorder, Non-24-Hour Sleep-Wake Syndrome, Advance Sleep-Phase Syndrome, Delayed Sleep-Phase Syndrome, Fixed night shift work between midnight and 5 a.m. or rotating work scheduled that required night shifts during course of pregnancy or participation;
e) Other previously diagnosed sleep disorders;
f) Mental health conditions as determined by the M.I.N.I. International Neuropsychiatric Interview 7.0 (referred for appropriate management): Major depressive disorder (current), posttraumatic stress disorder (current), panic disorder if associated with nocturnal panic attacks >4 times in the past month, bipolar disorder (lifetime), psychotic disorders (lifetime), substance abuse/dependence disorders (during pregnancy).

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)
Expectant mothers enrolled in Childbirth Education at the Royal Women's Hospital, Melbourne, Australia will be invited to participate in a research project that "aims to evaluate the benefits of two wellbeing programs for new mothers". Eligibility will be assessed via a structured interview. Treatment allocation will be conducted using computerized central randomization. Individual participant's allocation based on this plan will be stored in sealed envelopes, and will only be revealed immediately before randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomized into either the intervention or comparison condition using block randomization with random block sizes, which ensure equal sample sizes between groups over time. Randomization plan will be generated using an online tool (www.randomization.com), which generates permutations of group assignment in random blocks with equal numbers of either condition in each block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. Missing data will be assessed using full information maximum likelihood when structural equation modeling (SEM) frameworks are applied, and multiple imputation in other analyses.

To assess feasibility and acceptability of the program, descriptive statistics will be used to characterize recruitment/dropout rates and patient satisfaction/feedback data.

To examined group differences in primary and secondary outcomes at baseline and each subsequent time point, multiple regression analyses will be conducted with treatment condition (along with relevant covariates) as independent variables, and the outcome of interest as dependent variable. Changes in outcomes over time will be examined using latent growth models based on SEM; potential predictors of treatment response will be incorporated as relevant time-invariant and/or time-varying covariates in these models, so their effects on change trajectories can be examined.

Participants will be 150 expectant mothers, and their infants (150 mother-infant dyads, total N = 300). Mothers (n = 150) will be randomized. Assuming 5% missing data at T1 and 15% at each follow-up, the study is powered adequately at 80% (two-tailed alpha=0.05) to detect a moderate sized difference; moderate to large sized are expected for primary outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6803 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 14460 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 294687 0
Charities/Societies/Foundations
Name [1] 294687 0
Australasian Sleep Association Rob Pierce Grant-in-Aid
Address [1] 294687 0
114/30 Campbell St.
Blacktown 2148
New South Wales
Country [1] 294687 0
Australia
Funding source category [2] 294688 0
University
Name [2] 294688 0
Monash University Strategic Grant Scheme
Address [2] 294688 0
Faculty of Medicine, Nursing, and Health Sciences
10 Ancora Imparo Way,
Monash University
Clayton Victoria 3800
Country [2] 294688 0
Australia
Funding source category [3] 297880 0
Hospital
Name [3] 297880 0
Royal Women's Hospital Foundation
Address [3] 297880 0
The Royal Women's Hospital
Locked Bag 300
Grattan St & Flemington Rd
Parkville VIC 3052 AUSTRALIA
Country [3] 297880 0
Australia
Funding source category [4] 300652 0
Government body
Name [4] 300652 0
NHMRC Health Professional Research Fellowship
Address [4] 300652 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [4] 300652 0
Australia
Funding source category [5] 300653 0
Government body
Name [5] 300653 0
Australian Postgraduate Award
Address [5] 300653 0
Department of Education and Training
GPO Box 9880
Canberra ACT 2601
Country [5] 300653 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd.
Clayton, VIC, 3800
Country
Australia
Secondary sponsor category [1] 293532 0
Hospital
Name [1] 293532 0
Royal Women's Hospital
Address [1] 293532 0
Cnr Grattan St & Flemington Rd.
Parkville VIC 3052
Country [1] 293532 0
Australia
Secondary sponsor category [2] 293550 0
University
Name [2] 293550 0
Stanford University
Address [2] 293550 0
401 Quarry Rd
Stanford, CA 94305
Country [2] 293550 0
United States of America
Secondary sponsor category [3] 293551 0
Commercial sector/Industry
Name [3] 293551 0
Smiling Mind
Address [3] 293551 0
15/644 Chapel Street
South Yarra VIC 3141
Australia
Country [3] 293551 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296112 0
Royal Women's Hospital Research Ethics Committee
Ethics committee address [1] 296112 0
Cnr Grattan St & Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 296112 0
Australia
Date submitted for ethics approval [1] 296112 0
Approval date [1] 296112 0
04/05/2016
Ethics approval number [1] 296112 0
16/01
Ethics committee name [2] 296113 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 296113 0
Human Ethics Office
Monash University
Room 111, Chancellery Building E
24 Sports Walk, Clayton Campus, Wellington Rd, Clayton
VIC 3800
Ethics committee country [2] 296113 0
Australia
Date submitted for ethics approval [2] 296113 0
Approval date [2] 296113 0
17/05/2016
Ethics approval number [2] 296113 0
CF16/1561-2016000815

Summary
Brief summary
Sleep disturbance is experienced by the majority of child-bearing women during the pregnancy and post-partum periods. Physiological changes related to pregnancy and birth-giving (e.g., hormonal changes), and post-partum nighttime infant care are common factors that reduce/disrupt sleep opportunity. In addition, some women (~17%) experience clinically significant insomnia symptoms. The resulting sleep complaints have been associated with a range of poor maternal outcomes (e.g., mood disturbance, worse birth outcomes, poorer maternal-infant attachment).
Integrated behavioral and educational interventions have been consistently shown to improve sleep, and have lasting effects on sleep and wellbeing. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective insomnia treatment, and recently has been tailored to, and piloted on, women with comorbid postpartum depression and insomnia with significant improvements to sleep and mood.

Given the proven efficacy of CBT-I and the need to prioritize treatment accessibility in the community, the lack of a flexible delivery service platform for healthy sleep strategies represents a significant gap in clinical translation. Given the high prevalence of sleep disturbance in perinatal periods, a platform that can be easily integrated into routine perinatal care, as well as being accessible to a broad community is desirable. However, expectant mothers in most of Australia are not currently receiving evidence-based information and recommendations to prepare and support them through the many changes to sleep/wake cycles during the transition into motherhood.
This study will adapt an existing evidence-based perinatal sleep intervention for use in an Australian public hospital setting and include features that allow for sustainable integration into routine care, promoting eventual wider dissemination.

The primary aims of the study are to obtain pilot data on 1) the feasibility of integrating this adaptation in outpatient perinatal care, and 2) its treatment effect on sleep and wellbeing in mothers and infants. To achieve this aim, a comparison group, Diet SEED will be used.

A secondary aim of the study is exploratory, and assesses potential benefits of Diet SEED on participants' diet. From a diet perspective, the Sleep SEED group will be treatment as usual (as outpatients). Currently, diet related information is given to women in a text-dense booklet. By adapting content of this booklet to digestible sizes that are delivered at important perinatal milestones, Diet SEED has the potential to improve women's diet behaviors significantly compared to treatment as usual. Therefore, to achieve this aim, dietary measures will be compared between Sleep and Diet SEED groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69594 0
Dr Bei Bei
Address 69594 0
Monash Institute of Cognitive and Clinical Neurosciences
Sleep Program
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country 69594 0
Australia
Phone 69594 0
+61 3 9905 3903
Fax 69594 0
Email 69594 0
bei.bei@monash.edu
Contact person for public queries
Name 69595 0
Dr Bei Bei
Address 69595 0
Monash Institute of Cognitive and Clinical Neurosciences
Sleep Program
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country 69595 0
Australia
Phone 69595 0
+61 3 9905 3903
Fax 69595 0
Email 69595 0
bei.bei@monash.edu
Contact person for scientific queries
Name 69596 0
Dr Bei Bei
Address 69596 0
Monash Institute of Cognitive and Clinical Neurosciences
Sleep Program
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country 69596 0
Australia
Phone 69596 0
+61 3 9905 3903
Fax 69596 0
Email 69596 0
bei.bei@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent for IPD use not explicitly sought. However, an application for waiver will be made in the future, and if approved, IPD will be made available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary