The Baby Care Study

Obesity Clinical Trial

Official title:

The Baby Care Study: Online Support for New Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322174
• Other study ID #: STUDY00005999
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: October 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Eating Behavior
• Obesity
• Parenting
• Sleep

Intervention

Behavioral:
• Baby Sleep
See arm description
• Baby Care
See arm description

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Limit exposure	Limit exposure subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Other	Mealtime routines	Mealtime routines subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Other	Restriction	Restriction subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Other	Pressure to eat	Pressure to eat subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)	Follow-up (infant age 7 months)
Other	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)
Other	Emotion regulation	Regulation superfactor from the Infant Behavior Questionnaire Very Short Form (Rothbart)	Follow-up (infant age 7 months)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)