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临床试验/NCT02148237
NCT02148237已完成不适用

Intervention to Increase Breastfeeding Duration Among Puerto Rican Mothers

Treatment Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Duration of breastfeeding

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Contingency Management (Behavioral)

结局指标

主要结局

Duration of breastfeeding

时间窗: 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.

次要结局

  • Infant weight(1-month, 3-month, and 6-month postpartum)

研究者

发起方
Treatment Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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