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Postpartum DepressionNCT06148831

Carrying for the Culture

A study testing Infant Carrier in people with Postpartum Depression and Breast Feeding, run by Nurturely at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Suboptimal postpartum health outcomes in the US, including low rates of lactation and high rates of postpartum depression, contribute to high rates of perinatal mortality and morbidity as well as long-term and intergenerational health outcomes. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Depression, Breast Feeding
What is being tested?
Infant Carrier
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
8 Jan 2024to 27 Jan 2026
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Current participant of one of the participating agencies
  • 18 years of age or over
  • Currently pregnant
  • Singleton pregnancy
  • Fluent in one of the study languages
  • Consistent access to a smartphone with internet access
  • Working email account
  • Physical and mental capability to use an infant carrier, follow study plan, and document participation

Who cannot join

  • Not a current participant of a partner agency
  • Under 18 years of age
  • More than a singleton birth
  • Inconsistent access to smartphone or internet access
  • No working email
  • Cannot use an infant carrier

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nurturely

    Eugene, Oregon, 97401

Other trials in United States

About this study

Official title: Carrying for the Culture: RCT

Suboptimal postpartum health outcomes in the US, including low rates of lactation and high rates of postpartum depression, contribute to high rates of perinatal mortality and morbidity as well as long-term and intergenerational health outcomes. Black birthing parents and infants are at the highest risk, with the lowest rates of lactation and the highest rates of postpartum depression. Yet most interventions to support lactation and postpartum mental health are based on models of care that are unrepresentative of Black and global majority communities. The principal investigator's previous Randomized Controlled Trial (RCT) using soft infant carriers to increase parent-infant physical contact was effective in increasing lactation and decreasing postpartum depression in a sample of Latinx postpartum parents. Infant carrying, or "babywearing," is a culturally relevant prevention strategy based on models of parenting representative of Black and global majority communities. In this study, the investigators use strategies from implementation research and clinical effectiveness research to assess an infant carrier intervention within a community-based, culturally specific perinatal home visiting program for Black birthing parents.

Read the detailed description

Low rates of lactation and high rates of postpartum depression contribute to perinatal mortality and morbidity and Black birthing parents and infants are at the highest risk. Yet most interventions to support lactation and postpartum mental health are based on models of care that are unrepresentative of Black and global majority communities. The principal investigator's (PI) previous Randomized Controlled Trial (RCT) using soft infant carriers was effective in increasing lactation and decreasing postpartum depression in a sample of Latinx postpartum parents.

Black infants are half as likely as white infants to be breastfed at 3 and 6 months, and 12 months. Black parents also experience an increased risk of perinatal mental health challenges like postpartum depression yet are less likely to initiate and/or follow up with mental health treatment due to societal stigma on mental health and lack of access to financial resources, amongst other reasons. Low lactation rates are associated with immediate threats to infant and parental health, including increased risk of infection, asthma risk, and diarrhea. Longer-term health impacts are suboptimal brain development, decreased academic and cognitive performance, an increased risk of childhood obesity, and an increased risk of breast and ovarian cancer and diabetes in the parent. Supporting lactation and mental health in the postpartum period provides an opportunity for immediate, long-term, and intergenerational impact. Yet most interventions to support lactation and mental health are based on cultural models of care that are unrepresentative of the postpartum practices of Black and global majority communities. They can also be costly and add burdens to both parents and the professionals supporting intervention implementation.

This study employs carrying as an intervention that is culturally rooted, cost-effective, and does not add burdens. Keeping a baby strapped to a caregiver's body with a textile-based device, known as "babywearing," "backing," or simply "infant carrying," is a practice that has likely existed since the beginning of human history. Among the global majority, infant carrying and sustained parent-infant contact is not only culturally and historically ubiquitous but is also very well understood for its benefits. International fieldwork (Guatemala and Congo) by the PI and others document the ubiquity of parent-infant physical contact. This cultural variation in mother-infant physical contact is reflected in patterns of breastfeeding behavior, such that in communities where infants are in more physical contact with caregivers they are breastfed for longer, a pattern that has been documented both across cultures (e.g., between parents in Washington DC and Central African Republic) and within cultures (two groups of parents in London). Only a handful of studies have tested whether this cultural practice of infant carrying is contributing to lactation outcomes. An RCT published by the PI demonstrated that an infant carrier intervention increased lactation rates in a low-income Latina population. Using a randomized two-arm, parallel-group trial conducted in collaboration with a home-visiting program in a low-income, urban, and primarily Latinx community, 50 parents were randomly assigned to receive an ergonomic infant carrier and instruction on proper use to facilitate increased physical contact with infants (intervention group), and 50 parents were assigned to a waitlist control group. Parents in the intervention group were more likely to be breastfeeding or feeding expressed human milk at 6 months (68%) than control group parents (40%; P = .02). Another study in Italy showed that an intervention with infant carriers to increase mother-infant physical contact increased the likelihood of continued breastfeeding, and two US-based studies demonstrated increased attachment between parent and infant after an intervention with infant carriers. These effects of infant carrying in the months after birth align with the decades of evidence from RCTs in hospital and NICU settings demonstrating that skin-to-skin contact immediately after birth has both immediate and long-term benefits after preterm birth, including increased lactation and decreased postpartum depression. Though effectiveness has now been demonstrated in some communities, no research thus far has tested the effectiveness of infant carrying interventions among Black parents in the US, who are experiencing the most inequities in lactation and postpartum mental health. Furthermore, no research has assessed strategies for effectively implementing this intervention in scalable, community-based settings.

Being tested
Infant Carrier
Medical subject headings
Depression, Postpartum, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infant CarrierDevice

    The assigned home visitor will provide a participant with an infant carrier and will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client to practice using the carrier and will provide materials to support continued learning.

    All home visitors participated in an infant carrier training developed by Nurturely, centered on carrying as a cultural practice, utilizing culturally relevant visuals as well as easy-to-remember acronyms to promote safe and ergonomic use (i.e., the STOP acronym developed by Nurturely, signifying that all knots are Secure, infant is attached high enough to kiss the top of their head and Tight to the caregiver's body, nose and mouth are visible and airway is Open, and hips are Positioned in an ergonomic spread squat).

Study groups in NCT06148831
Study groupRoleWhat they receive
Infant CarrierExperimentalIn the intervention group, in the prenatal period (~37 weeks gestation) will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.
Receives: Device: Infant Carrier
Infant Carrier WaitlistNo interventionParticipants assigned to the waitlist control will receive home visitation care as usual. At 6-months postpartum they will watch a short training video on how to use the carrier, including a demonstration of safe and ergonomic use. The home visitor will support the client in practicing using the carrier and will provide materials to support continued learning.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression Scale Score of Each Participant

    Edinburgh Post Natal Depression Scale: The score ranges from 0 to 30 with a score of 13-30 indicating a high risk of depressive illness

    Measured: Postpartum week 6, 12, 24

  2. Number of Weeks of Lactation of Each Participant

    Self reported duration of lactation

    Measured: Postpartum week 6, 12, 24, 52

  3. Proportion of Parents who Exclusively Breastfed their Infant

    Self reported exclusive breastfeeding (yes/no)

    Measured: Postpartum week 6, 12, 24, 52

  4. Lactation Frequency of Each Participant

    Self-reported frequency of human milk feeds per day

    Measured: Postpartum week 6, 12, 24, 52

  5. Cultural Models of Infant Care Score of Each Participant

    Parenting Ethnotheories Scale: The score ranges from 10 to 50 with higher scores indicating a greater alignment with proximal care parenting practices and a lower score indicating a greater alignment with distal care parenting practices

    Measured: Postpartum week 6, 12, 24

Secondary outcomes (5)
  1. Average Crying Frequency of Infant

    Self-reported average number of hours infant cries per day

    Measured: Postpartum week 6, 12, 24

  2. Participant Breastfeeding Self-Efficacy Score

    Breastfeeding Self-Efficacy Scale - Short Form: The score ranges from 14 to 70 with higher scores indicating more confidence in breastfeeding

    Measured: Postpartum week 6, 12, 24

  3. Participant Ability to Access Human Milk Score

    Nurturely Milk Mobility Scale: The score ranges from 16 to 80 with a higher score indicating more ability to access milk (either on their own or from donors).

    Measured: Postpartum week 6, 12, 24

  4. Participant Responsiveness to Infant Feeding Cues Score

    Nurturely Feeding Responsiveness Scale: The score ranges from 9 to 45 with a higher score indicating increased responsiveness to infant cues during feeding

    Measured: Postpartum week 6, 12, 24

  5. Mother to Infant Bonding Scale Score

    Mother to Infant Bonding Scale: The score ranges from 0 to 16 with a higher score indicating less bonding

    Measured: Postpartum week 6, 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2023
  2. Study start8 Jan 2024
  3. Primary completion27 Jan 2026
  4. Study completion27 Jan 2026

Why it stopped: Lack of Funding

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06148831
Sponsor's protocol ID
23
Status last verified
Jan 2026
First submitted
9 Nov 2023
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Little EE, Cioffi CC, Bain L, Legare CH, Hahn-Holbrook J. An Infant Carrier Intervention and Breastfeeding Duration: A Randomized Controlled Trial. Pediatrics. 2021 Jul;148(1):e2020049717. doi: 10.1542/peds.2020-049717. Epub 2021 Jun 30.

    PubMed 34193622
  • Little EE, Polanco MA, Baldizon SR, Wagner P, Shakya H. Breastfeeding knowledge and health behavior among Mayan women in rural Guatemala. Soc Sci Med. 2019 Dec;242:112565. doi: 10.1016/j.socscimed.2019.112565. Epub 2019 Sep 26.

    PubMed 31627080
  • Little EE, Bain L, Hahn-Holbrook J. Randomized controlled trial to prevent postpartum depressive symptomatology: An infant carrier intervention. J Affect Disord. 2023 Nov 1;340:871-876. doi: 10.1016/j.jad.2023.08.044. Epub 2023 Aug 15.

    PubMed 37586649
  • Little EE, Legare CH, Carver LJ. Culture, carrying, and communication: Beliefs and behavior associated with babywearing. Infant Behav Dev. 2019 Nov;57:101320. doi: 10.1016/j.infbeh.2019.04.002. Epub 2019 May 16.

    PubMed 31103747
  • Little EE, Legare CH, Carver LJ. Mother(-)Infant Physical Contact Predicts Responsive Feeding among U.S. Breastfeeding Mothers. Nutrients. 2018 Sep 6;10(9):1251. doi: 10.3390/nu10091251.

    PubMed 30200623

Questions about this trial

What is this clinical trial studying?

A study testing Infant Carrier in people with Postpartum Depression and Breast Feeding, run by Nurturely 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Jan 2026. 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 was withdrawn before enrolling participants, so there are no results.

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?

Depression Scale Score of Each Participant (time frame: Postpartum week 6, 12, 24). The study lists 5 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 NCT06148831, which also lists 5 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 29 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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