The Baby Care Study

Not Applicable

Completed

• Conditions: Sleep; Parenting; Eating Behavior; Obesity

• Registration Number: NCT05322174
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Study Start: 2022-04-13
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of infant night wakings	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	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	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 Outcome Measures

Name	Time	Method
Parenting satisfaction	From baseline (infant age 6 weeks) to follow-up (age 7 months)	Satisfaction scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston \& Wandersman)
Infant's longest sleep bout	From baseline (infant age 6 weeks) to follow-up (age 7 months)	Longest sleep bout for the infant, item written by the study team
Parent sleep duration	From baseline (infant age 6 weeks) to follow-up (age 7 months)	Total hours of sleep per night reported by the parent, from the Pittsburgh Sleep Quality Index (Buysse)
Parent stress	From baseline (infant age 6 weeks) to follow-up (age 7 months)	Stress scores from the Perceived Stress Scale (Cohen) (minimum value = 0, maximum value = 40; higher scores mean more stress)
Parenting self-efficacy	From baseline (infant age 6 weeks) to follow-up (age 7 months)	Efficacy scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston \& Wandersman)

Trial Locations

Locations (1)

University at Buffalo; 🇺🇸 Buffalo, New York, United States