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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Prevention of Obesity Through Infancy Interventions

Conditions
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Weight Gain, Obesity

Intervention / Treatment
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* Behavioral: Infant Sleeping and Soothing
* Behavioral: Repeated Food Exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Soothing and Calming instructions given at 2 weeks of life | Behavioral: Infant Sleeping and Soothing<br>* Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.<br>|
| Experimental: 2<br>Repeated food exposure instructions given between 4 and 6 months of life | Behavioral: Repeated Food Exposure<br>* Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.<br>|
| Experimental: 3<br>Receive both interventions: Soothing and Calming and Repeated food exposure | Behavioral: Infant Sleeping and Soothing<br>* Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.<br>Behavioral: Repeated Food Exposure<br>* Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.<br>|
| No Intervention: 4<br>Group receiving neither of the interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of infants sleeping 5 consecutive hours at night at 2 months of age |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration breastfed |  | 2 years | 
| Rate of weight gain |  | 2.5 years | 
| Self-regulation of emotion |  | 3 years | 
| Timing of introduction of solids |  | 3 years | 
| Infant dietary variety |  | 3 years | 
| Maternal feeding style |  | 3 years | 
| Infant temperament |  | 3 years | 
| Body Composition |  | 3 years | 
| Lab evaluation |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Sleep, Infant Diet, Infant Temperament, Rapid Infant weight gain, Infant Development, Parenting Competence, infant weight gain