Novel Intervention to Increase Lactation Practices by African American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Breastfeeding rates
研究概览
简要总结
This trial studies how well an informational intervention works in increasing lactation practices by African American women. Giving additional information about breastfeeding and breast cancer risks to African American women may help doctors understand the factors that affect the decision to breast feed and to test whether providing useful information about breastfeeding will change breastfeeding behavior.
详细描述
PRIMARY OBJECTIVES:
I. Develop appropriate intervention strategies about the "breastfeeding-breast cancer connection" appropriate for use by experienced Women, Infants and Children (WIC) Peer Counselors (PCs) to disseminate to African-American mothers through a community-based participatory research (CBPR) approach including social media..
II. Assess the comparative cognitive (e.g., knowledge, utility, cost-benefit), affective association (e.g., feelings), socioeconomic, familial and intent/outcome (e.g., breastfeeding) measures pre- and post-intervention to determine effectiveness of the content to impact cognitive and feeling measures and increase breastfeeding in young African-American mothers compared to an existing counseling program.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: Participants receive standard information about pregnancy and breastfeeding. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant African American women participating in the Catholic Charities WIC Program
- •INCLUSION - FOCUS GROUPS: Representative mothers, spouses/partners, influential family members (e.g., grandmothers, sisters) from the families served during the study.
- •INCLUSION - FOCUS GROUPS: Partners/spouses may include men or women.
排除标准
- •Unwilling or unable to follow protocol requirements.
结局指标
主要结局
Breastfeeding rates
时间窗: Up to 1 year
Will be assessed by estimating a logistic regression model with breastfeeding as the dichotomous outcome variable and intervention condition as a predictor variable.
Affective associations with breastfeeding
时间窗: Up to 1 year
Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which affective associations with breastfeeding mediate any intervention impact on breastfeeding behavior and behavioral intentions.
Perceived risk for breast cancer
时间窗: Up to 1 year
Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which perceived risk for breast cancer mediate any intervention impact on breastfeeding behavior and behavioral intentions.
Qualitative analysis of focus group and key informant interviews
时间窗: Up to 1 year
Will be recorded and transcribed. This text will be coded and categorized by Erwin following methods established in earlier research. The PEN-3 Model analysis will focus on the most salient factors as they apply to what will be considered the ?Positive, Existential, Negative? influences within the Cultural Empowerment domain in reference to breastfeeding and formula feeding topics. Will sort the responses into categories in a 3 x 3 table according to the Relationships and Expectations domain factors, ?Perceptions, Enablers, Nurturers,? on one axis, and the ?Positive, Existential, Negative? factors across the other axis. This categorical analysis will be reviewed and edited and the Women, Infants and Children (WIC) peer counselors (PCs) to increase validity of the process.
Behavioral intentions for breastfeeding
时间窗: Up to 1 year
Linear regression analyses will be conducted with condition and necessary covariates as predictors.
Perceptions of benefits and barriers to breastfeeding
时间窗: Up to 1 year
Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which perceptions of benefits and barriers to breastfeeding mediate any intervention impact on breastfeeding behavior and behavioral intentions.
次要结局
未报告次要终点