The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
Condition: Weight Gain; Obesity
MeSH terms: Obesity; Weight Gain
Study type: Interventional
Phase: Phase 1

Summary: 
      Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even
      among very young children. Because the current evidence base regarding potentially effective
      early intervention components to prevent obesity is so incomplete, it is logical to initiate
      obesity prevention intervention research during infancy, focusing on the two major components
      of the infant lifestyle, sleeping and feeding.
    

Detailed description: 
      Rationale: Childhood obesity has reached epidemic proportions and its prevalence continues to
      rise, even among very young children. A recent report from the National Health and Nutrition
      Examination Survey (NHANES) revealed that between 2003-2004, a staggering 26.2% of children
      aged 2 to 5 years were already overweight or at-risk for overweight. As such, in the summary
      of the "Conference on Preventing Childhood Obesity," it was remarked that researchers should
      particularly consider the youngest of children when planning obesity related interventions.
      Because the current evidence base regarding potentially effective early intervention
      components is so incomplete, it is logical to initiate obesity prevention intervention
      research during infancy, focusing on the two major components of the infant lifestyle,
      sleeping and feeding.

      Key Objectives:

      Aim 1: To evaluate the effect of simple procedures, taught to parents in the home environment
      by visiting nurses, that trains parents to calm their infants and increase their nocturnal
      sleep duration, thereby influencing sleep duration, nocturnal feeding frequency, and weight
      gain during infancy.

      Aim 2: To evaluate a simple training procedure for parents, taught in the home environment by
      visiting nurses, that promotes infants' acceptance of nutritious, developmentally appropriate
      weaning foods.

      Aim 3: To evaluate the delivery of these behavioral interventions to parents by community
      based home health nurses.

      Aim 4: To examine the effect of a soothing intervention designed to increase sleep duration
      on overall maternal regulation of emotion, self-regulation of emotion, and weight gain.

      Study Population: 160 newborns and mothers that demonstrate intent to breastfeed during the
      newborn nursery stay will be recruited during the maternity hospitalization. Approximately
      25-50 physicians from the university affiliated pediatric and family practices.
    

Intervention name(s): Infant Sleeping and Soothing; Repeated Food Exposure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.; Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Infant Sleep; Infant Diet; Infant Temperament; Rapid Infant weight gain; Infant Development; Parenting Competence; infant weight gain