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| Name | Class |
|---|---|
| Project Concern International | OTHER |
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To test the hypothesis that increased mother-infant physical contact affects the likelihood of mothers exclusively breastfeeding their child for the first six months of life, the investigators will randomly assign half of the participating mothers to receive a baby carrier to use with their baby (to facilitate increased physical contact) while the other half of babies and mothers will receive standard care.
One hundred mothers participating in the California Border Healthy Start (CBHS) program will be randomly assigned to the physical contact group or the control group. Mothers in the physical contact group will be provided with an infant carrier to use from birth to facilitate increased mother-infant physical contact. In the control group, mothers will be provided with an infant carrier, but will not receive the carrier until postpartum week 24, once study measures have been collected. This type of multiple-baseline design will allow the investigators to objectively assess the effect of physical contact during the first six months, but will also ensure that mothers in both groups have the opportunity to benefit from the potentially positive intervention of a high quality infant carrier to promote increased mother-infant physical contact. The two groups will be compared on: 1) likelihood of exclusive breastfeeding, 2) extent of breastfeeding exclusivity (proportion of feeds that are breastmilk versus formula or other), 3) likelihood of initiating feeding in response to hunger cues versus crying (i.e., maternal responsiveness during feeding), 4) maternal score on the Edinburgh Postnatal Depression Scale (EPDS), 5) prevalence of breastfeeding difficulties, 6) score on the Mother-Infant Bonding Scale, and 7) beliefs about breastfeeding and infant care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Contact | Experimental | Baby carrier (and education) provided to mother to increase physical contact with baby |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Babywearing | Behavioral | Increase mother-infant physical contact through babywearing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of infant feeds coming from breastmilk versus formula | Self-report feeding log | Postpartum Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Edinburgh Postnatal Depression Scale (EPDS) | Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased depressive symptoms | Postpartum Week 6 |
| Score on the Mother-Infant Bonding Questionnaire |
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Inclusion Criteria:
To be eligible to participate in this study, participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily E Little, PhD | Nurturely | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Concern International | San Diego | California | 92105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37586649 | Derived | 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. | |
| 34193622 | Derived | 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. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
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Standardized self-report questionnaire with a possible score from 0-30, with a higher score indicating increased problems with bonding |
| Postpartum Week 24 |
| Score on the Proximal Care Beliefs Questionnaire | Standardized self-report questionnaire with a possible score from 6-30, with a higher score indicating increased alignment with the caretaking practices of proximal care culture | Postpartum Week 12 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |