Carrying for the Culture

NCT06148831 | Withdrawn

• 1 other identifier: 23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postpartum Depression; Breast Feeding

Outcome Measures

Primary Outcomes (5)

• 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

  Postpartum week 6, 12, 24

• Number of Weeks of Lactation of Each Participant

  Self reported duration of lactation

  Postpartum week 6, 12, 24, 52

• Proportion of Parents who Exclusively Breastfed their Infant

  Self reported exclusive breastfeeding (yes/no)

  Postpartum week 6, 12, 24, 52

• Lactation Frequency of Each Participant

  Self-reported frequency of human milk feeds per day

  Postpartum week 6, 12, 24, 52

• 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

  Postpartum week 6, 12, 24

Secondary Outcomes (5)

• Average Crying Frequency of Infant

  Postpartum week 6, 12, 24

• Participant Breastfeeding Self-Efficacy Score

  Postpartum week 6, 12, 24

• Participant Ability to Access Human Milk Score

  Postpartum week 6, 12, 24

• Participant Responsiveness to Infant Feeding Cues Score

  Postpartum week 6, 12, 24

• Mother to Infant Bonding Scale Score

  Postpartum week 6, 12, 24

Study Arms (2)

Infant Carrier

EXPERIMENTAL

In 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.

Device: Infant Carrier

Infant Carrier Waitlist

NO INTERVENTION

Participants 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.

Interventions

Infant Carrier DEVICE

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).

Infant Carrier

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: has a uterus; currently pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current participant of one of the participating agencies
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurturely: lead

Study Sites (1)

Nurturely

Eugene, Oregon, 97401, United States

Location

Related Publications (5)

• 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.

  PMID: 34193622 BACKGROUND

• 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.

  PMID: 31627080 BACKGROUND

• 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.

  PMID: 37586649 BACKGROUND

• 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.

  PMID: 31103747 BACKGROUND

• 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.

  PMID: 30200623 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Breast Feeding

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: At the time of consent, the participant is randomly assigned to the intervention or control group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 28, 2023
• Study Start: January 8, 2024
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)