Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359242
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2006-07-28
Brief Title:
The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life SLIMTIME Project
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Primary Prevention of Obesity Through Infancy Interventions
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 262 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant Number R56DK072996 | None | None | None |