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Trial registered on ANZCTR


Registration number
ACTRN12617000976381
Ethics application status
Approved
Date submitted
22/06/2017
Date registered
6/07/2017
Date last updated
17/11/2020
Date data sharing statement initially provided
17/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing obesity through sleep education in infants
Scientific title
Targeting infant sleep for prevention of overweight: a pilot study to inform a proposed randomised controlled trial
Secondary ID [1] 291975 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 303319 0
Condition category
Condition code
Public Health 302762 302762 0 0
Health promotion/education
Diet and Nutrition 302983 302983 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study proposes a preliminary trial of methods in 20 families, who would be the target of a proposed intervention, i.e. those at risk of having an infant becoming overweight or obese in later years. Potential parents will be identified from the point of antenatal booking to the local maternity hospital or through lead maternity carers. Parents will be invited to link to an online survey that will assess their eligibility to enrol in the study using prenatal risk factors for child overweight based on maternal pre-pregnancy and paternal BMI, gestational smoking, ethnicity, young maternal age (less than 20 years) and proxies for low SES. They will be eligible if both parents are overweight (BMI of at least 25) or at least one is obese (BMI of at least 30) plus at least one other risk factor is present. Families will be retrospectively excluded if their infant is born preterm (less than 36 weeks), or if a congenital abnormality or a physical or intellectual disability is present that is likely to affect sleep, feeding or growth. Families will receive one antenatal education session (around 37 weeks gestation) & 3 postnatal consultations (3 wks, 12wks, 5 mnths). All sessions will take place within the participant’s homes with a trained sleep educator (Registered Nurse with over 20 years research experience). Antenatal sessions will include education about normal developmental sleep patterns and the practice of enabling infants to self-settle to sleep. Parents will receive a video demonstrating self-settling (http://www.raisingchildren.org.nz/stories/newborn-sleeping/), written guidelines & reference tools (from our earlier POI study, Pediatrics 2017:139:e20162037). Postnatal visits will offer support tailored to each infant’s sleep & family routines, with an emphasis on self-settling techniques. At 5 months, parents will complete a 7 day sleep diary prior to the consultation, so that a plan specifically tailored to any infant sleep problem can be addressed. Between intervention study support will include brief monthly phone calls & a cell phone number for participants to call or text at any time to discuss sleep issues with the educator. All resources are based on sleep tools established in previous studies by our group. Assessment methods to be tested include the use of fixed video cameras and self-worn auto-cameras to capture sleep & wake activity & self-settling behaviour. A current project is determining the wearability of these cameras & how well they capture self-settling and sleep timing, whilst ensuring a number of privacy issues are upheld. Acceptance of the trial methods and intervention will be ascertained when the infant is aged 5 months, through a questionnaire & face-to-face exit interviews. Families will be asked to rate the intervention as a whole, as well as individual components of the intervention. Other data will be collected as part of the trial including demographic information, anthropometry, feeding practices, and sleep behaviour (actigraphy).
At recruitment & 5 months of age, validated questionnaires will be used to assess parental sleep quantity & quality (Pittsburgh Sleep Quality Index), fatigue (Fatigue Assessment Scale), symptoms of depression (Edinburgh Postnatal Depression Scale) & parental expectations & interpretations around infant sleep behaviour (Brief Infant Sleep Questionnaire, Maternal Cognitions about Infant Sleep Questionnaire). Data will not be sufficient to use these questionnaires as formal outcome measures. However, we need to include them as part of our piloting as they would be included in a larger trial.
In summary, taking part in the study will involve (for families):
- Either a clinic visit or a home visit during pregnancy to talk about infant sleep and to complete some questionnaires (up to 60 minutes). Resources provided to the family include information on normal sleep, safe sleep practices, sleep expectations and a gentle introduction to self-settling.
- A home visit when baby is 3 weeks old to talk about the baby’s sleep. The researcher will leave a sleep diary to complete (over 2 days) and set up a small camera for the baby to wear to record sleep (up to 60 minutes). Resources include a video clip from the Raising Children network site (NZ) http://www.raisingchildren.org.nz/stories/newborn-sleeping/, and a comprehensive booklet outlining how to encourage healthy sleep patterns in the infant.
- A home visit when baby is 12 weeks old to talk about the baby’s sleep. The researcher will leave a sleep diary to complete (over 2 days) (up to 60 minutes). Resources include information on bedtime practices and handouts on techniques for improving sleep if required (parental presence, camping out and controlled comforting). Verbal discussion and support is also provided.
- A home visit when baby is 5 months old to talk about baby’s’ sleep, measure baby, complete some questionnaires and to attach a watch-like device that measures when baby is sleeping or awake. The researcher will leave a sleep diary to complete (over 2 days) and set up a small camera for baby to wear to record sleep (up to 60 minutes). Resources include information about encouraging good sleep in later infancy and the toddler years.
The main aim of all these visits is to support the family by helping with baby’s sleep, as well as gathering information for research purposes. At the end of the study researchers will ask questions about how it was for the family taking part in the study and how researchers can improve any part of it for the bigger study. Intervention fidelity will not be assessed formally as it is being delivered by a single researcher.
Intervention code [1] 298102 0
Prevention
Intervention code [2] 298103 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302153 0
To assess the acceptability of an infant sleep intervention by parents who are at risk of having an overweight or obese child, Acceptability will be measured using a single question (5-point Likert scale).
Timepoint [1] 302153 0
When infants are 5 months old (study end point).
Secondary outcome [1] 334974 0
To assess the feasibility of the intervention. This will be determined from qualitative analysis of exit interviews with parents. We will ask about i) how they found the intervention, ii) what aspects they thought were useful/not useful, iii) what changes they would recommend, and iv) how they found the questionnaires and other assessments.
Timepoint [1] 334974 0
When infants are 5 months old (study end point),

Eligibility
Key inclusion criteria
Infants of parents with pre-natal risk factors for child overweight based on maternal pre-pregnancy and paternal Body Mass Index (BMI), gestational smoking, ethnicity, young maternal age (less than 20years) and proxies for low socioeconomic status will be eligible.
They will be eligible if both parents are overweight (BMI of at least 25) or at least one is obese (BMI of at least 30) plus at least one other risk factor is present.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families will be retrospectively excluded if their infant is born preterm (<36 weeks), or if the infant has a congenital abnormality or a physical or developmental disability is likely to affect sleep, feeding or growth.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No sequence generation applied
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot study of 20 families only (to inform a proposed RCT).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Summary statistics will be used to describe parental responses to the evaluation questionnaire. Statistical anaylses will be completed using STATA 13.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
1/10/2017
Date of last participant enrolment
Anticipated
31/01/2018
Actual
30/04/2018
Date of last data collection
Anticipated
28/02/2019
Actual
31/01/2019
Sample size
Target
20
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 8908 0
New Zealand
State/province [1] 8908 0
OTAGO

Funding & Sponsors
Funding source category [1] 296484 0
University
Name [1] 296484 0
Univeristy of Otago Research Grant
Country [1] 296484 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Barbara Galland
Address
Department of Women's and Children's Health
Dunedin School of Medicine
University of Otago
PO BOX 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 295442 0
Individual
Name [1] 295442 0
Professor Rachael Taylor
Address [1] 295442 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country [1] 295442 0
New Zealand
Other collaborator category [1] 279578 0
Individual
Name [1] 279578 0
Professor Barry Taylor
Address [1] 279578 0
Deans Department
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country [1] 279578 0
New Zealand
Other collaborator category [2] 279579 0
Individual
Name [2] 279579 0
Rachel Sayers
Address [2] 279579 0
Department of Women's and Children's Health
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country [2] 279579 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297706 0
Health and Disability Ethics Committees
Ethics committee address [1] 297706 0
Ethics committee country [1] 297706 0
New Zealand
Date submitted for ethics approval [1] 297706 0
11/05/2017
Approval date [1] 297706 0
07/07/2017
Ethics approval number [1] 297706 0
17/CEN/96

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

Contacts
Principal investigator
Name 74898 0
A/Prof Barbara Galland
Address 74898 0
Department of Women's and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 74898 0
New Zealand
Phone 74898 0
+64 3 470 9478
Fax 74898 0
Email 74898 0
barbara.galland@otago.ac.nz
Contact person for public queries
Name 74899 0
Rachel Sayers
Address 74899 0
Department of Women's and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 74899 0
New Zealand
Phone 74899 0
+64 3 4709760
Fax 74899 0
Email 74899 0
rachel.sayers@otago.ac.nz
Contact person for scientific queries
Name 74900 0
Barbara Galland
Address 74900 0
Department of Women's and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 74900 0
New Zealand
Phone 74900 0
+64 3 470 9478
Fax 74900 0
Email 74900 0
barbara.galland@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9773Study protocol  barbara.galland@otago.ac.nz
9774Informed consent form  barbara.galland@otago.ac.nz
9776Ethical approval  barbara.galland@otago.ac.nz



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.