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Completed

NCT Number: NCT00359242

The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project

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.

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Key information

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 34 0/7 weeks gestational age
  • Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
  • Singleton infant
  • Nursery or NICU stay of 7 days or less
  • Primiparous mother
  • Maternity stay of 7 days or less
  • Pediatric primary care provider from one of 3 University-affiliated pediatric practices or University-affiliated family medicine practices
  • Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
  • English speaking mother.

Exclusion criteria

  • Newborn nursery, NICU, or maternity stay > 7 days
  • Exclusive formula feeding in the nursery or NICU
  • Multiparous mother
  • Any metabolic condition that requires feedings at precise intervals
  • Gestational age of 33 6/7 weeks or less
  • Presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip or cleft palate) or sleeping (hyperexplexia - exaggerated startle reflex)
  • Non-singleton newborn

Treatment and study plan

Infant Sleeping and Soothing

Behavioral

Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.

Repeated Food Exposure

Behavioral

Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.

Primary outcomes

  1. Percent of infants sleeping 5 consecutive hours at night at 2 months of age

    Time frame: 2.5 years

Secondary outcomes

  1. Duration breastfed

    Time frame: 2 years

  2. Rate of weight gain

    Time frame: 2.5 years

  3. Self-regulation of emotion

    Time frame: 3 years

  4. Timing of introduction of solids

    Time frame: 3 years

  5. Infant dietary variety

    Time frame: 3 years

  6. Maternal feeding style

    Time frame: 3 years

  7. Infant temperament

    Time frame: 3 years

  8. Body Composition

    Time frame: 3 years

  9. Lab evaluation

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Gerber Products Company
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Primary Prevention of Obesity Through Infancy Interventions

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 1, 2006
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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