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临床试验/NCT03964454
NCT03964454已完成不适用

Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers

Philadelphia College of Osteopathic Medicine4 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2019年6月19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
入组人数
168
试验地点
4
主要终点
Number of Participants Breastfeeding Their Infants at 1 Month

研究概览

简要总结

This behavioral intervention trial will test whether a standard care breastfeeding intervention from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program plus monthly financial incentives contingent on observed breastfeeding will improve breastfeeding duration among low-income mothers compared to a standard (WIC) care control. Investigators hypothesize that the standard care plus monthly contingent financial incentives intervention will promote longer breastfeeding duration, fewer infant health issues, and greater healthcare cost savings than the standard care (control) intervention.

详细描述

Low-income racial/ethnic-minority women have greater challenges with breastfeeding uptake and duration than the general population, resulting in an average breastfeeding duration of four months. This duration is substantially shorter than evidence-based recommendations by the American Academy of Pediatrics to exclusively breastfeed for six months in addition to continued breastfeeding through the first year. Insufficient duration of any breastfeeding is related to multiple maternal and child health problems and increases in breastfeeding duration could be cost saving medically and societally.

Even though breastfeeding counseling and peer support have been effective in prolonging breastfeeding duration in the general maternal population, the effect has not been as strong for WIC-eligible (Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)), low-income mothers. Examining novel adjunctive intervention components that could enhance standard WIC counseling and support is warranted. We tested an incentive-based intervention among low-income Puerto Rican mothers in a pilot study. Results suggested strong potential for efficacy of monthly financial incentives contingent on observed breastfeeding for 6 months combined with WIC usual care, compared to WIC usual care only.

The current, full-scale randomized trial will test the efficacy and generalizability of the 6-month incentive-based approach to increase breastfeeding duration in WIC-eligible mothers through 12 months. The aims of the study are guided by the mission of NICHD's Pregnancy and Perinatology Branch to improve the long-term maternal and infant health of low-income populations via encouraging breastfeeding in the translational research context.

This study is a 2-group, multi-site, parallel randomized controlled trial. The study will be conducted in two regional sites with high concentrations of low-income racial/ethnic minority mothers, Philadelphia, PA and Newark, DE. Participants (n=168) include WIC-eligible mothers who will be allocated into one of the two study groups: (1) A Standard Care Control (SC) group consisting of breastfeeding support through WIC, with home-based individual support, or (2) Standard Care plus Incentives contingent on demonstrating successful breastfeeding (SC+BFI).

Participants randomized into SC will receive standard breastfeeding services from WIC plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. Participants randomized into SC+BFI will receive the same WIC services and monthly home visits as the SC group, with addition of financial incentives following each home visit that are contingent on observed breastfeeding.

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
Single (Outcomes Assessor)

盲法说明

Those who are providing home visitations on a monthly basis will be blinded to which condition a participant gets randomized.

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • mothers must initiate breastfeeding
  • mothers must be WIC-enrolled or eligible to enroll in WIC services
  • mothers must reside and plan to stay in the study county for 12 months postpartum
  • mothers must consent voluntarily
  • mothers must understand fifth grade level of English
  • mothers must be at least 18 years old

排除标准

  • mothers whose babies are medically contraindicated against breastfeeding
  • mothers who are hospitalized for severe postpartum medical issues
  • mothers who have ongoing illicit drug use issues
  • mothers who had a psychiatric hospitalization within the last three months
  • mothers who currently have suicidal thoughts or attempts

研究组 & 干预措施

SC + BFI

Experimental

Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding.

干预措施: WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) (Behavioral)

SC

Active Comparator

Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.

干预措施: WIC support + home-based individual support (SC) (Behavioral)

结局指标

主要结局

Number of Participants Breastfeeding Their Infants at 1 Month

时间窗: 1 month

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Number of Participants Breastfeeding Their Infants at 3 Months

时间窗: 3 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Number of Participants Breastfeeding Their Infants at 6 Months

时间窗: 6 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Number of Participants Breastfeeding Their Infants at 9 Months

时间窗: 9 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Number of Participants Breastfeeding Their Infants at 12 Months

时间窗: 12 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

次要结局

  • Infant Weight(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yukiko Washio

Research Faculty

Philadelphia College of Osteopathic Medicine

研究点 (4)

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