Clinical trial NCT05322174: The Baby Care Study
Official title: The Baby Care Study: Online Support for New Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Parenting
Eating Behavior
Obesity
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.).

Primary outcomes:
measure: Nighttime infant sleep duration
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
measure: Total infant sleep duration
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
measure: Number of infant night wakings
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Secondary outcomes:
measure: Infant's longest sleep bout
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
measure: Parent sleep duration
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
measure: Parent stress
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
measure: Parenting self-efficacy
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
measure: Parenting satisfaction
timeFrame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Other outcomes:
measure: Infant routines
timeFrame: Mid-point (infant age 3 months) to post-test (infant age 4 months)
measure: Limit exposure
timeFrame: Follow-up (infant age 7 months)
measure: Mealtime routines
timeFrame: Follow-up (infant age 7 months)
measure: Restriction
timeFrame: Follow-up (infant age 7 months)
measure: Pressure to eat
timeFrame: Follow-up (infant age 7 months)
measure: Nutritional quality
timeFrame: Follow-up (infant age 7 months)
measure: Emotion regulation
timeFrame: Follow-up (infant age 7 months)
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
References: