NCT05322174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

March 28, 2022

Last Update Submit

October 3, 2023

Conditions

SleepParentingEating BehaviorObesity

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (5)

  • Infant's longest sleep bout

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

  • Parent sleep duration

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

  • Parent stress

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

  • Parenting self-efficacy

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

  • Parenting satisfaction

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

Other Outcomes (7)

  • Infant routines

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

  • Limit exposure

    Follow-up (infant age 7 months)

  • Mealtime routines

    Follow-up (infant age 7 months)

  • +4 more other outcomes

Study Arms (2)

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).

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.

Behavioral: Baby Care

Interventions

Baby SleepBEHAVIORAL

See arm description

Baby Sleep
Baby CareBEHAVIORAL

See arm description

Baby Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (2)

  • 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). 2025 Oct 26. doi: 10.1002/oby.70037. Online ahead of print.

    PMID: 41140015DERIVED

  • Anzman-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.

    PMID: 40438635DERIVED

MeSH Terms

Conditions

Feeding BehaviorObesity

Interventions

Infant Care

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 11, 2022

Study Start

April 13, 2022

Primary Completion

February 3, 2023

Study Completion

February 3, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

US(1)