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Increase Breastfeeding Duration Among Puerto Rican Mothers (BFCM)

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ClinicalTrials.gov Identifier: NCT02148237
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Treatment Research Institute

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).

Condition or disease Intervention/treatment Phase
Breastfeeding Behavioral: Contingency Management Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention to Increase Breastfeeding Duration Among Puerto Rican Mothers
Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
No Intervention: Treatment as Usual
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
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
Participants in this condition will receive usual WIC care in addition to Contingency Management (CM). BF will be determined by direct observation.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148237


Locations
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United States, Pennsylvania
Special Supplemental Nutrition Program for Women, Infants, and Children
Philadelphia, Pennsylvania, United States, 19134
Sponsors and Collaborators
Treatment Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Yukiko Washio, Ph.D. Treatment Research Institute

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Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT02148237     History of Changes
Other Study ID Numbers: R03HD077057 ( U.S. NIH Grant/Contract )
1R03HD077057-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Treatment Research Institute:
Breastfeeding duration
Puerto Rican mothers
WIC program
Home-based individual breastfeeding consultation