SleepNCT05322174
The Baby Care Study
A study testing Baby Sleep and Baby Care in people with Sleep and Parenting, run by State University of New York at Buffalo at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Parenting, Eating Behavior
- What is being tested?
- Baby Sleep and Baby Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2022to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep, Parenting, Eating Behavior, Obesity
- Being tested
- Baby Sleep, Baby Care
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby SleepBehavioural
See arm description
Baby CareBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Baby Sleep | Experimental | 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). Receives: Behavioral: Baby Sleep |
| Baby Care | Active comparator | 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. Receives: Behavioral: Baby Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime infant sleep duration
Total hours of nighttime sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)
Measured: 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)
Measured: 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)
Measured: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Secondary outcomes (5)
Infant's longest sleep bout
Longest sleep bout for the infant, item written by the study team
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start13 Apr 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Anzman-Frasca, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322174
- Sponsor's protocol ID
- STUDY00005999
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anzman-Frasca S, Goldsmith J, Hassinger AB, Wilding G, Buxton OM, Savage JS. Exploring Effects of a Randomized Online Infant Sleep Intervention on Weight-Related Outcomes Into Toddlerhood. Obesity (Silver Spring). 2026 Jun;34 Suppl 1:9-17. doi: 10.1002/oby.70037. Epub 2025 Oct 26.
PubMed 41140015Anzman-Frasca S, Goldsmith J, Hassinger AB, Savage JS, Gupta V. Implementation and Effects of an Online Intervention Designed to Promote Sleep During Early Infancy: A Randomized Trial. Nat Sci Sleep. 2025 May 24;17:1037-1048. doi: 10.2147/NSS.S501807. eCollection 2025.
PubMed 40438635
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Baby Care Study: Online Support for New Parents
- ClinicalTrials.gov ID
- NCT05322174
- Acronym / sponsor ID
- STUDY00005999
- Conditions
- Sleep, Parenting, Eating Behavior, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby Sleep | Experimental | Behavioral: Baby SleepThose 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). |
| Baby Care | Active comparator | Behavioral: Baby CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby SleepSee arm description | Behavioural | Baby Sleep |
| Baby CareSee arm description | Behavioural | Baby Care |
Primary outcome
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)
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)
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)
5 secondary outcomes
Infant's longest sleep bout
Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Parent sleep duration
Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Parent stress
Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Parenting self-efficacy
Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Parenting satisfaction
Time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 41140015Anzman-Frasca S, Goldsmith J, Hassinger AB, Wilding G, Buxton OM, Savage JS. Exploring Effects of a Randomized Online Infant Sleep Intervention on Weight-Related Outcomes Into Toddlerhood. Obesity (Silver Spring). 2026 Jun;34 Suppl 1:9-17. doi: 10.1002/oby.70037. Epub 2025 Oct 26.
- Derived from this study: PubMed 40438635Anzman-Frasca S, Goldsmith J, Hassinger AB, Savage JS, Gupta V. Implementation and Effects of an Online Intervention Designed to Promote Sleep During Early Infancy: A Randomized Trial. Nat Sci Sleep. 2025 May 24;17:1037-1048. doi: 10.2147/NSS.S501807. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Sleep and Baby Care in people with Sleep and Parenting, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nighttime infant sleep duration (time frame: From baseline (infant age 6 weeks) to follow-up (age 7 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.