Clinical trial NCT02148237: Increase Breastfeeding Duration Among Puerto Rican Mothers
Official title: Intervention to Increase Breastfeeding Duration Among Puerto Rican Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding duration
Puerto Rican mothers
WIC program
Home-based individual breastfeeding consultation
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-05-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

1. Identify as Puerto Rican or of Puerto Rican descent
2. be able to read Spanish or English
3. currently live in the area and plan to stay until 12 months postpartum
4. be able to participate in Spanish-speaking peer-support group meetings
5. consent to participate
6. pass an informed consent quiz
7. successfully initiate BF
8. be within 15-44 years of age

Exclusion Criteria:

1. Have ongoing illicit drug use
2. have current active suicidal thoughts or a past suicide attempt, or a psychiatric hospitalization within the last 3 months
3. have untreated HIV (BF contraindicated)
4. are currently prescribed psychotropic medication (i.e., antidepressants, antipsychotics, mood stabilizers, anxiolytics)
5. have serious postpartum medical problems (e.g., postpartum hemorrhage, infections and serious jaundice requiring exchange transfusion)

Primary outcomes:
measure: Duration of breastfeeding
timeFrame: 6-month postpartum
Secondary outcomes:
measure: Infant weight
timeFrame: 1-month, 3-month, and 6-month postpartum
Other outcomes:
measure: Coercion assessment
timeFrame: Weekly group meetings, assessments after delivery, 1-month postpartum, 3-month postpartum, and 6-month postpartum
measure: Postnatal Depression
timeFrame: After delivery, 1-month, 3-month, and 6-month postpartum
measure: Breastfeeding self-efficacy scale
timeFrame: After delivery, 1-month, 3-month, and 6-month postpartum
measure: Satisfaction survey
timeFrame: 6-month postpartum
Locations:
city: Philadelphia
country: United States
facility: Special Supplemental Nutrition Program for Women, Infants, and Children
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Yukiko Washio, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: