Healthy Sleeping and Feeding During Infancy

NCT00125580 | Completed Phase 1

• 1 other identifier: 20970EP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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 from 1999 to 2002, 10.3% of children ages 2 to 5 were overweight, an increase from 7% in 1994. Epidemiologic evidence is now emerging that suggests obesity in childhood and adulthood may often originate from accelerated weight gain during infancy. Further data are accumulating that link short sleep duration with obesity during childhood and later life. Prospective data are lacking that demonstrate whether the accelerated weight gain during infancy can be prevented and whether interventions to improve sleep early in life can prevent childhood obesity. Key Objectives: The key objectives are:

• To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care; and
• To evaluate, in the primary care setting, the effect of a simple training procedure on overnight sleep duration and rate of weight gain during the first four months of life.

Conditions

Obesity

Keywords

Obesity; Childhood Obesity; Infant Sleep; Infant growth; Infant feeding

Outcome Measures

Primary Outcomes (1)

• The rate of sleeping through the night at 8 weeks of age between treatment groups (intervention versus standard treatment)

Secondary Outcomes (1)

• Across the study period, infant weight gain will be measured to study differences between treatment groups.

Interventions

Infant sleep instruction BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥37 weeks gestation
• Primiparous mother (first pregnancy)
• Singleton
• Breast or bottle-fed
• Birth weight ≥2500 grams

You may not qualify if:

• \<37 weeks gestation
• Multiparous mother {see above comment}
• Twin or multiple infant
• Birth weight \<2500 grams
• Maternal conditions causing prolonged hospital stay or "non-routine" postpartum follow-up (except for diabetes mellitus: type 1, 2, or gestational)
• Infants with chronic illnesses or anomalies that require non-routine care or follow-up

Sponsors & Collaborators

• Penn State University: lead

Study Sites (2)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Paul, MD, MSc

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 1, 2005
• Study Start: August 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (2)