Increase Breastfeeding Duration Among Puerto Rican Mothers

Study Overview
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Brief Summary
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This study is to determine preliminary effects of home-based individual breastfeeding consultation with and without cash incentives to increase breastfeeding (BF) duration among low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Detailed Description
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This study is to determine feasibility, acceptability, and preliminary effect sizes of home-based individual breastfeeding consultation alone and combined with financial incentives to increase breastfeeding (BF) duration among low-income Puerto Rican mothers. These interventions will be tested in a Women, Infants, and Children (WIC) program, which capitalizes on the current goals of WIC and on the current practice of using incentives to support BF - factors that are likely to increase potential for sustainability and dissemination of the intervention. We will follow a three phase strategy. During the Formative Phase we will consult WIC staff, Puerto Rican postpartum mothers, and experts in BF, behavioral health incentives, and WIC populations and settings to develop intervention and research manuals. During the Implementation Phase, we will pilot the interventions and research procedures. We will randomly assign 60 Puerto Rican women who initiate BF to: Treatment-as-Usual (TAU) or TAU with financial incentives (also known as Contingency Management; (CM). A bilingual breastfeeding counselor visits participants at home for problem solving issues around breastfeeding. Participants also receiving CM will receive cash incentives if they show breastfeeding. We will conduct assessments at baseline, 1, 3, and 6 months postpartum, measuring BF duration, BF exclusivity, BF self-efficacy, and infant weight gain. In the Evaluative Phase, we will examine monthly recruitment, consent, and enrollment rates, as well as attendance and retention rates for the interventions and for research participation (i.e., feasibility and acceptability).

Official Title
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Intervention to Increase Breastfeeding Duration Among Puerto Rican Mothers

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify as Puerto Rican or of Puerto Rican descent be able to read Spanish or English currently live in the area and plan to stay until 12 months postpartum be able to participate in Spanish-speaking peer-support group meetings consent to participate pass an informed consent quiz successfully initiate BF be within 15-44 years of age Exclusion Criteria: Have ongoing illicit drug use have current active suicidal thoughts or a past suicide attempt, or a psychiatric hospitalization within the last 3 months have untreated HIV (BF contraindicated) are currently prescribed psychotropic medication (i.e., antidepressants, antipsychotics, mood stabilizers, anxiolytics) have serious postpartum medical problems (e.g., postpartum hemorrhage, infections and serious jaundice requiring exchange transfusion)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual<br>Participants in Treatment as Usual (TAU) will receive standard breastfeeding (BF) services from the WIC program and participate in research assessments. Standard services include an on-site and home-visiting lactation consultant, occasional one-on-one peer counseling, and an enhanced food package for BF women. | |
| Experimental: Contingency Management<br>These participants will receive usual WIC care. The frequency, duration, content, and size of the meetings and participation requirements will be the same as for the TAU group, except that this group will also receive contingency management (CM). Members will demonstrate breastfeeding and receive cash incentives weekly if they breastfeed. | Behavioral: Contingency Management<br>* Participants in this condition will receive usual WIC care in addition to Contingency Management (CM). BF will be determined by direct observation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of breastfeeding | Observe breastfeeding (BF) behavior looking for one of the following indicators of successful BF in the infant: audible swallowing, a regular suck/swallow/breathe pattern, or visible milk in the infant's mouth after they are not latched anymore. For a mother who pumps milk, observation of pumping combined with observation of the resulting milk being fed to the infant will be observed. | 6-month postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant weight | An infant will be weighed at each assessment time point using a portable Health O Meter Infant Scale. | 1-month, 3-month, and 6-month postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding duration, Puerto Rican mothers, WIC program, Home-based individual breastfeeding consultation