title: Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.
abstract: BACKGROUND
  Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.
  
  
  METHODS
  The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months.
  
  
  CONCLUSIONS
  The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.
  
  
  BACKGROUND
  ClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil. inasantos@uol.com.br.
authors: Ina S
authors: IS
authors: Santos
authors: Centre for Global Child Health, The Hospital for Sick Children and Department of Pediatrics, University of Toronto, Toronto, Canada.
authors: Diego G
authors: DG
authors: Bassani
authors: Department of Preventive Medicine, School of Medicine, University of Sao Paulo, São Paulo, SP, Brazil.
authors: Alicia
authors: A
authors: Matijasevich
authors: Hospital da Criança Conceição - Ministry of Health, Porto Alegre, RS, Brazil.
authors: Camila S
authors: CS
authors: Halal
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil.
authors: Bianca
authors: B
authors: Del-Ponte
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil.
authors: Suélen Henriques
authors: SH
authors: da Cruz
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil.
authors: Luciana
authors: L
authors: Anselmi
authors: Department of Maternal and Child Health, Faculty of Medicine, Federal University of Pelotas, Pelotas, RS, Brazil.
authors: Elaine
authors: E
authors: Albernaz
authors: Oxford Maternal and Perinatal Health Institute International Research Fellow, Nuffield Department of Obstetrics and Gynaecology, The John Radcliffe Hospital, University of Oxford, Toronto, UK.|Core Clinical Fellow in Paediatrics, Department of Paediatrics, Southampton General Hospital and Southampton University, Southampton, UK.
authors: Michelle
authors: M
authors: Fernandes
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil.
authors: Luciana
authors: L
authors: Tovo-Rodrigues
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil.
authors: Mariangela F
authors: MF
authors: Silveira
authors: Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil.
authors: Pedro C
authors: PC
authors: Hallal
mesh_terms: D002657:Child Development; D002675:Child, Preschool; D002985:Clinical Protocols; D037001:Directive Counseling; D005260:Female; D006792:House Calls; D006801:Humans; D007223:Infant; D007224:Infant Care / Q000379:methods*; D009035:Mothers; D000068356:Self-Control; D016037:Single-Blind Method; D012890:Sleep; D000070263:Sleep Hygiene; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: Child development; Child growth; Sleep