The Baby Care Study

Study Overview
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Brief Summary
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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.

Official Title
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The Baby Care Study: Online Support for New Parents

Conditions
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Sleep, Parenting, Eating Behavior, Obesity

Intervention / Treatment
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* Behavioral: Baby Sleep
* Behavioral: Baby Care


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baby Sleep<br>Those randomized to this intervention group will receive an interactive online intervention focused on promoting infant sleep. This will include membership in a private Facebook group with support provided in the group, including weekly resources in the form of videos and tip sheets. To supplement this, they will also receive items meant to help with sleep (ex. sleep sack, baby sleep book). | Behavioral: Baby Sleep<br>* See arm description<br>|
| Active Comparator: Baby Care<br>The active control condition will parallel the intervention, but will be focused on general baby care and not sleep. Participants will be added to a private Facebook group in which general baby care information will be shared (e.g., bathing, play) and will receive items to help with general baby care (e.g., baby care kit with items such as nail clippers and comb; general baby care book). Topics related to sleep and feeding will not be highlighted in this group. | Behavioral: Baby Care<br>* See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nighttime infant sleep duration | Total hours of nighttime sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh) | From baseline (infant age 6 weeks) to follow-up (age 7 months) | 
| Total infant sleep duration | Total hours of sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh) | From baseline (infant age 6 weeks) to follow-up (age 7 months) | 
| Number of infant night wakings | Number of night wakings for the infant, from the Brief Infant Sleep Questionnaire (Sadeh) | From baseline (infant age 6 weeks) to follow-up (age 7 months) | 

Secondary Outcome Measures

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