NCT02148237

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

May 23, 2014

Last Update Submit

March 27, 2023

Conditions

Breastfeeding

Keywords

Breastfeeding durationPuerto Rican mothersWIC programHome-based individual breastfeeding consultation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Infant weight

    1-month, 3-month, and 6-month postpartum

Other Outcomes (4)

  • Coercion assessment

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

  • Postnatal Depression

    After delivery, 1-month, 3-month, and 6-month postpartum

  • Breastfeeding self-efficacy scale

    After delivery, 1-month, 3-month, and 6-month postpartum

  • +1 more other outcomes

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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.

Contingency Management

EXPERIMENTAL

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

Interventions

Contingency ManagementBEHAVIORAL

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

Contingency Management

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Supplemental Nutrition Program for Women, Infants, and Children

Philadelphia, Pennsylvania, 19134, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Yukiko Washio, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

US(1)