NCT00359242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

July 28, 2006

Last Update Submit

July 25, 2017

Conditions

Weight GainObesity

Keywords

Infant SleepInfant DietInfant TemperamentRapid Infant weight gainInfant DevelopmentParenting Competenceinfant weight gain

Outcome Measures

Primary Outcomes (1)

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

    2.5 years

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

Soothing and Calming instructions given at 2 weeks of life

Behavioral: Infant Sleeping and Soothing

2

EXPERIMENTAL

Repeated food exposure instructions given between 4 and 6 months of life

Behavioral: Repeated Food Exposure

3

EXPERIMENTAL

Receive both interventions: Soothing and Calming and Repeated food exposure

Behavioral: Infant Sleeping and SoothingBehavioral: Repeated Food Exposure

4

NO INTERVENTION

Group receiving neither of the interventions.

Interventions

Infant Sleeping and SoothingBEHAVIORAL

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

13
Repeated Food ExposureBEHAVIORAL

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

23

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \> 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Related Publications (1)

  • Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19.

    PMID: 20725058DERIVED

Related Links

MeSH Terms

Conditions

Weight GainObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Leann Birch, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Ian M Paul, MD, MSc

    Milton S. Hershey Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

June 1, 2006

Primary Completion

November 1, 2008

Study Completion

December 1, 2009

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

US(1)