The Baby Care Study

The Baby Care Study: Online Support for New Parents

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Sleep; Parenting; Eating Behavior
• Intervention / Treatment: Behavioral: Baby Sleep; Behavioral: Baby Care

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby Sleep; 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; See arm description
Active Comparator: Baby Care; 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; See arm description

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant routines	Routine subscale from the Infant Parenting Styles Questionnaire (Arnott & Brown)	Mid-point (infant age 3 months) to post-test (infant age 4 months)
Limit exposure	Limit exposure subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Mealtime routines	Mealtime routines subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Restriction	Restriction subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Pressure to eat	Pressure to eat subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Nutritional quality	We will create a composite variable that is a proxy for nutritional quality using the frequencies that the consumption of various food groups (vegetables, fruit, fried food, sweets) are reported	Follow-up (infant age 7 months)
Emotion regulation	Regulation superfactor from the Infant Behavior Questionnaire Very Short Form (Rothbart)	Follow-up (infant age 7 months)

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00005999

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No