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The Baby Care Study

The Baby Care Study: Online Support for New Parents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05322174
Enrollment
74
Registered
2022-04-11
Start date
2022-04-13
Completion date
2023-02-03
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Behavior, Obesity, Parenting, Sleep

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.

Interventions

BEHAVIORALBaby Sleep

See arm description

BEHAVIORALBaby Care

See arm description

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Participants are randomly assigned to one of two online, behavioral interventions. Because the participants will know which behaviors are promoted to their group, and study staff will be interacting with the participants in their groups, masking is not possible. However, which group is considered the main intervention versus the attention control will not be known to participants.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.).

Design outcomes

Primary

MeasureTime frameDescription
Nighttime infant sleep durationFrom 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)
Number of infant night wakingsFrom 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)
Total infant sleep durationFrom 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

MeasureTime frameDescription
Infant's longest sleep boutFrom 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 durationFrom 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 stressFrom 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-efficacyFrom baseline (infant age 6 weeks) to follow-up (age 7 months)Efficacy scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston & Wandersman)
Parenting satisfactionFrom baseline (infant age 6 weeks) to follow-up (age 7 months)Satisfaction scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston & Wandersman)

Other

MeasureTime frameDescription
Limit exposureFollow-up (infant age 7 months)Limit exposure subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
RestrictionFollow-up (infant age 7 months)Restriction subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Mealtime routinesFollow-up (infant age 7 months)Mealtime routines subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Pressure to eatFollow-up (infant age 7 months)Pressure to eat subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Nutritional qualityFollow-up (infant age 7 months)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
Emotion regulationFollow-up (infant age 7 months)Regulation superfactor from the Infant Behavior Questionnaire Very Short Form (Rothbart)
Infant routinesMid-point (infant age 3 months) to post-test (infant age 4 months)Routine subscale from the Infant Parenting Styles Questionnaire (Arnott & Brown)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026