Tummytime: Determining Optimal Dosage of Prone Positioning in Early Infancy

Sponsor
State University of New York - Upstate Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03134859
Collaborator
(none)
35
3
43

Study Details

Study Description

Brief Summary

The proposed study is a longitudinal, randomized control trial designed to determine the dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and healthy body composition. Infants will be randomly assigned to one of three 'tummy time' groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to achieve the maximal minutes prescribed for their group and will keep a log of their daily tummy time. Participating infants will be assessed in their home for motor development and body composition at study entry and again every month for 12 months, at 15 months of age and at 18 months of age.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tummy Time
N/A

Detailed Description

Prone positioning or 'tummy time' in early infancy is advocated as important to support early motor development, improve overall strength, and prevent flattening of the back of the head. The American Academy of Pediatrics state that "a certain amount of prone positioning, or 'tummy time,' while the infant is awake and being observed is recommended to help prevent the development of flattening of the occiput and to facilitate development of the upper shoulder girdle necessary for timely attainment of certain motor milestones." However, specific recommendations on appropriate dosage of prone positioning are not available. In the absence of these specific recommendations, many infants may not be engaging in sufficient 'tummy time' for timely motor development. Moreover, insufficient 'tummy time' is linked to heightened obesity risk in early life. Given the increasing incidence of obesity in infants, primary preventative efforts need to begin early to reduce this risk.

The proposed study is a longitudinal, randomized control trial designed to determine the dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and healthy body composition. Infants will be randomly assigned to one of three 'tummy time' groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to achieve the maximal minutes prescribed for their group and will keep a log of their daily tummy time. Participating infants will be assessed in their home for motor development and body composition at study entry and again every month for 12 months, at 15 months of age and at 18 months of age. Once a participant can independently transition in and out of the sitting position, the family will no longer be responsible for performing deliberate 'tummy time' activities or logging, but monthly motor development and body composition will continue to be monitored until the participant is 18 months of age.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Determining Optimal Dosage of Prone Positioning to Facilitate Motor Development and Body Composition in Early Infancy
Anticipated Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0 to 30 min/day tummy time

Group tasked to engage in an accumulation of 0 to 30 minutes of deliberate tummy time activities daily from study entry until the time at which the infant can independently transition in and out of sitting

Behavioral: Tummy Time
deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
Other Names:
  • prone positioning
  • Experimental: 31-60 min/day tummy time

    Group tasked to engage in an accumulation of 31 to 60 minutes of deliberate tummy time activities daily from study entry until the time at which the infant can independently transition in and out of sitting

    Behavioral: Tummy Time
    deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
    Other Names:
  • prone positioning
  • Experimental: >61 min/day tummy time

    Group tasked to engage in an accumulation of 61 or more minutes of deliberate tummy time activities daily from study entry until the time at which the infant can independently transition in and out of sitting

    Behavioral: Tummy Time
    deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
    Other Names:
  • prone positioning
  • Outcome Measures

    Primary Outcome Measures

    1. Motor Development over time (longitudinal design) [study entry to 18 months of age]

      Motor skills as determined by the Bayley Motor Scales, 3rd edition

    2. Ponderal Index over time (longitudinal design) [study entry to 18 months of age]

      Estimate of body composition in infants (weight in kg/height in meters cubed)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 8 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • full term infants with typical development
    Exclusion Criteria:
    • premature birth before 37 weeks gestation; known medical condition or diagnosis; any complications that limit full participation in the intervention activities

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • State University of New York - Upstate Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erin Wentz PT PhD PCS, Assistant Professor, Department of Physical Therapy, State University of New York - Upstate Medical University
    ClinicalTrials.gov Identifier:
    NCT03134859
    Other Study ID Numbers:
    • TTDSUNYMU
    First Posted:
    May 1, 2017
    Last Update Posted:
    May 5, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Erin Wentz PT PhD PCS, Assistant Professor, Department of Physical Therapy, State University of New York - Upstate Medical University

    Study Results

    No Results Posted as of May 5, 2017