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Completed

NCT Number: NCT02148237

Increase Breastfeeding Duration Among Puerto Rican Mothers

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).

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Key information

Age range

15 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Special Supplemental Nutrition Program for Women, Infants, and Children

Philadelphia, Pennsylvania, 19134, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contingency Management

Behavioral

Participants in this condition will receive usual WIC care in addition to Contingency Management (CM). BF will be determined by direct observation.

Primary outcomes

  1. Duration of breastfeeding

    Time frame: 6-month postpartum

    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.

Secondary outcomes

  1. Infant weight

    Time frame: 1-month, 3-month, and 6-month postpartum

    An infant will be weighed at each assessment time point using a portable Health O Meter Infant Scale.

Other outcomes

  1. Coercion assessment

    Time frame: Weekly group meetings, assessments after delivery, 1-month postpartum, 3-month postpartum, and 6-month postpartum

    The Coercion Assessment Scale (CAS) is a 11-item questionnaire that measures perceived coercion to participate in research. The items examine pressures emanating from WIC staff and the research assistant. An initial support for the instrument's internal consistency, factor structure, and discriminative validity has been provided.

  2. Postnatal Depression

    Time frame: After delivery, 1-month, 3-month, and 6-month postpartum

    Edinburgh postnatal depression scale (EPDS) is a 10-item questionnaire that identifies patients at risk for perinatal depression. The EPDS was found to be sensitive and specific, especially sensitive to change in the severity of depression over time. The scale can be completed in about 5 minutes and scoring is very simple.

  3. Breastfeeding self-efficacy scale

    Time frame: After delivery, 1-month, 3-month, and 6-month postpartum

    Breastfeeding self-efficacy scale (BSES) is a 39-item questionnaire to measure maternal confidence in new BF mothers. The scale has demonstrated its predictive validity showing a positive correlation between BSES scores and infant feeding patterns at 6-week postpartum. The scale has been also useful to identify new mothers with low BF confidence at high risk for premature weaning. The scale has been translated into Spanish and replicated its validity and reliability with Puerto Rican mothers.

  4. Satisfaction survey

    Time frame: 6-month postpartum

    This is a brief 10-item inventory to assess the acceptability and satisfaction with the intervention It will be conducted with the 20 participants in the CM condition.. The questionnaire will include an item that (if applicable) asks why the participant did not complete the study.

Sponsors and collaborators

Lead sponsor

Treatment Research Institute

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Intervention to Increase Breastfeeding Duration Among Puerto Rican Mothers

Acronym: BFCM

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 28, 2014
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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