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Clinical Trials/NCT05322174
NCT05322174
Completed
N/A

The Baby Care Study: Online Support for New Parents

State University of New York at Buffalo1 site in 1 country74 target enrollmentApril 13, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sleep
Sponsor
State University of New York at Buffalo
Enrollment
74
Locations
1
Primary Endpoint
Number of infant night wakings
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The objective of this study is to provide pilot data on the feasibility and effectiveness of a web-based social networking intervention designed to promote sleep early in infancy and to explore the potential for this approach to promote healthy feeding routines, eating behaviors, and weight outcomes in subsequent larger-scale intervention research. First-time parents will be recruited (n=66) and randomized to an 8-week web-based social networking sleep intervention or general baby care control group with interventions beginning at infant age 8 weeks. Parents will complete online surveys, with research questions including: 1) whether the sleep intervention leads to longer nighttime and total sleep duration and decreased night waking among infants and 2) longer infant sleep bouts and improved parent sleep duration, stress, parenting efficacy, and parenting satisfaction. We will also examine infants' routines, feeding and eating behaviors, and emotion regulation to inform the application of this approach for childhood obesity prevention. The pilot research will provide insights into intervention feasibility, effects on infant sleep, and potential impacts on feeding and eating outcomes, informing our next steps.

Registry
clinicaltrials.gov
Start Date
April 13, 2022
End Date
February 3, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Anzman-Frasca

Associate Professor of Pediatrics

State University of New York at Buffalo

Eligibility Criteria

Inclusion Criteria

  • English-speaking, first-time parents/legal guardians \>18 years of a young infant who is \< 6 weeks at the time of recruitment (or pregnant first-time parents expecting an infant soon). We will not include any parents who report that they do not have access to or an interest in using a private group on social media and/or online surveys.

Exclusion Criteria

  • We will exclude families not meeting age criteria, as well as any parents who report that they do not have access to or an interest in using a private group on social media and/or online surveys. We will also exclude parents of infants who are born premature (prior to 37 weeks gestational age) and parents of multiples (twins, triplets, etc.).

Outcomes

Primary Outcomes

Number of infant night wakings

Time Frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)

Number of night wakings for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)

Nighttime infant sleep duration

Time Frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)

Total hours of nighttime sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)

Total infant sleep duration

Time Frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)

Total hours of sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)

Secondary Outcomes

  • Parenting satisfaction(From baseline (infant age 6 weeks) to follow-up (age 7 months))
  • Infant's longest sleep bout(From baseline (infant age 6 weeks) to follow-up (age 7 months))
  • Parent sleep duration(From baseline (infant age 6 weeks) to follow-up (age 7 months))
  • Parent stress(From baseline (infant age 6 weeks) to follow-up (age 7 months))
  • Parenting self-efficacy(From baseline (infant age 6 weeks) to follow-up (age 7 months))

Study Sites (1)

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