Skip to content

Preventing obesity through sleep education in infants

Targeting infant sleep for prevention of overweight: a pilot study to inform a proposed randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000976381
Acronym
TOTS
Enrollment
21
Registered
2017-07-06
Start date
2017-10-01
Completion date
2018-04-30
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our recent Prevention of Obesity in Infancy (POI) study demonstrated that a brief sleep intervention in infancy did not significantly affect mean body mass index at the group level. However, children who received the sleep intervention had approximately half the risk of obesity at two years of age, despite no change to sleep behaviours. Given these intriguing findings, we wish to trial a more intensive sleep intervention in those who would be more likely to benefit from such an intervention; families with infants at high risk of obesity later in childhood. Before we undertake a large controlled trial, we need to pilot i) recruitment strategies identifying children at risk of obesity from demographic details at birth, ii) new tools for objectively measuring sleep behaviour and iii) the feasibility and acceptability of the intervention for these groups. In summary, 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.

Interventions

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 overw

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.

Sponsors

Associate Professor Barbara Galland
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026