Healthy Sleeping and Feeding During Infancy

November 21, 2017 updated by: Penn State University

Healthy Sleeping and Feeding During Infancy: Pilot Study for the Primary Prevention of Obesity in Primary Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this proposal is to test, in a primary care setting, the effect of an established intervention designed to promote healthy feeding and sleeping behaviors early in life on risk factors for subsequent obesity. Because nocturnal feeding of infants, short sleep duration, and childhood obesity are linked, the procedure is designed to prevent short sleep duration and subsequently accelerated weight gain during infancy, two emerging risk factors for obesity in childhood and adulthood. In this study, 40 participants will be randomized to receive either an intervention that teaches infants to sleep through the night by 8 weeks of age or standard care. The procedure instructs parents to offer a "focal feed" before bedtime, avoid feeding as the first alternative to infant waking and distress, and carry out environmental control measures that emphasize day/night differences. In assessing the impact of the intervention, night wakening, and rate of weight gain will be assessed between birth and 4 months of age. The current proposal will test the feasibility of delivering this proven intervention in the primary care setting, an environment that must be included in primary preventive strategies for childhood obesity.

Aim 1: To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care.

This procedure, which instructs parents to offer a "focal feed" before bedtime, avoid feeding as the first alternative to infant waking and distress, and carry out environmental control measures that emphasize day/night differences has been successful at prolonging sleep duration in experimental settings. By demonstrating that subjects can be recruited from the newborn nursery, be taught the procedure at a primary care visit, and followed for four months, the feasibility of a larger study will be more apparent to external funding agencies.

Aim 2: 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.

It is hypothesized that the positive effect of the procedure in an experimental setting will be replicated in a randomized controlled trial in the primary care setting. By definition, teaching infants to sleep through the night will be manifest in longer sleep duration, which has been shown to be protective for childhood obesity in epidemiological studies. Sleeping through the night is hypothesized to promote protective factors for childhood obesity by supporting

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Investigators

  • Principal Investigator: Ian Paul, MD, MSc, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 29, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20970EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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