Increase Breastfeeding Duration Among Puerto Rican Mothers

NCT ID: NCT02148237

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-04-30

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).

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

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

Interventions

Contingency Management

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Treatment Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yukiko Washio, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Treatment Research Institute

Locations

Special Supplemental Nutrition Program for Women, Infants, and Children

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

1R03HD077057-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R03HD077057

Identifier Type: NIH

Identifier Source: org_study_id

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