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Completed

NCT Number: NCT05322174

The Baby Care Study

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.

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Key information

Conditions

Sleep Behavior Behavior, Animal Body Weight Eating Behavior Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Parenting Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14214, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Baby Sleep

Behavioral

See arm description

Baby Care

Behavioral

See arm description

Primary outcomes

  1. Nighttime infant sleep duration

    Time frame: From 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)

  2. Total infant sleep duration

    Time frame: From 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)

  3. Number of infant night wakings

    Time frame: From 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)

Secondary outcomes

  1. Infant's longest sleep bout

    Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)

    Longest sleep bout for the infant, item written by the study team

  2. Parent sleep duration

    Time frame: From 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)

  3. Parent stress

    Time frame: From 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)

  4. Parenting self-efficacy

    Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)

    Efficacy scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston & Wandersman)

  5. Parenting satisfaction

    Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)

    Satisfaction scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston & Wandersman)

Other outcomes

  1. Infant routines

    Time frame: Mid-point (infant age 3 months) to post-test (infant age 4 months)

    Routine subscale from the Infant Parenting Styles Questionnaire (Arnott & Brown)

  2. Limit exposure

    Time frame: Follow-up (infant age 7 months)

    Limit exposure subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)

  3. Mealtime routines

    Time frame: Follow-up (infant age 7 months)

    Mealtime routines subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)

  4. Restriction

    Time frame: Follow-up (infant age 7 months)

    Restriction subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)

  5. Pressure to eat

    Time frame: Follow-up (infant age 7 months)

    Pressure to eat subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)

  6. Nutritional quality

    Time frame: Follow-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

  7. Emotion regulation

    Time frame: Follow-up (infant age 7 months)

    Regulation superfactor from the Infant Behavior Questionnaire Very Short Form (Rothbart)

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

The Baby Care Study: Online Support for New Parents

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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