The Baby Care Study

October 3, 2023 updated by: Stephanie Anzman-Frasca, State University of New York at Buffalo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baby Sleep
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).
Behavioral: Baby Sleep
See arm description
Active Comparator: Baby Care
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.
Behavioral: Baby Care
See arm description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From baseline (infant age 6 weeks) to follow-up (age 7 months)
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)
From baseline (infant age 6 weeks) to follow-up (age 7 months)
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)
From baseline (infant age 6 weeks) to follow-up (age 7 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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)
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)
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)
Efficacy scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston & Wandersman)
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)
Satisfaction scale from the Parenting Sense of Competence Questionnaire (Gibaud-Wallston & Wandersman)
From baseline (infant age 6 weeks) to follow-up (age 7 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Mid-point (infant age 3 months) to post-test (infant age 4 months)
Limit exposure
Time Frame: Follow-up (infant age 7 months)
Limit exposure subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Follow-up (infant age 7 months)
Mealtime routines
Time Frame: Follow-up (infant age 7 months)
Mealtime routines subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Follow-up (infant age 7 months)
Restriction
Time Frame: Follow-up (infant age 7 months)
Restriction subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Follow-up (infant age 7 months)
Pressure to eat
Time Frame: Follow-up (infant age 7 months)
Pressure to eat subscale from the Structure & Control in Parent Feeding Questionnaire (Savage)
Follow-up (infant age 7 months)
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
Follow-up (infant age 7 months)
Emotion regulation
Time Frame: Follow-up (infant age 7 months)
Regulation superfactor from the Infant Behavior Questionnaire Very Short Form (Rothbart)
Follow-up (infant age 7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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