Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,050
- 试验地点
- 2
- 主要终点
- Percent adoption of the program
研究概览
简要总结
The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(Implementation Group (Low Touch and High Touch)):
- •Confirmed pregnant and <20 weeks 0 days gestational age
- •receiving care at one of the 10 clinics
- •≥18 years old
- •able to speak and read English or Spanish
- •Has a smartphone or mobile device with a data plan to accept text messages and internet connection to watch videos
- •Inclusion Criteria (Follow-up Group):
- •Enrolled as a subject in the Implementation Group (Low Touch or High Touch) within the first trimester (before the end of the 13th week (13w6d))
- •willing and able to provide consent for baseline and follow up surveys
排除标准
- •Significant psychiatric or developmental disability as noted in the medical record.
研究组 & 干预措施
Technology supported (Low Touch) Strategy
During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.
干预措施: Low Touch - Text Messaging Implementation Strategy (Behavioral)
Community Health Worker (High Touch Group)
During the intervention period (high touch) asynchronous and synchronous learning whereby content will be delivered by trained M-CHWs who are equipped to directly address social determinants of health-related needs and barriers to prenatal care.
干预措施: High Touch - Community Health Worker (CHW) Implementation Strategy (Behavioral)
结局指标
主要结局
Percent adoption of the program
时间窗: End of study (up to 5 years)
Adoption of the program will be measured as the number of patients correctly referred and enrolled offset by the number of eligible pregnant subjects screened
次要结局
- Adequacy of Prenatal Care Utilization Index Score(Month 12)
- Mean gestational weight gain(12 weeks postpartum)
- Number of subjects with post-partum depression(12 weeks postpartum)
- Mean number of videos viewed(Month 12)
- Level of adherence(Month 12)
- Number of postpartum follow-up visits attended(12 weeks postpartum)
- Number of subjects who had a pre-term delivery(12 weeks postpartum)
- Mean number of sessions completed(Month 12)
- Percent sustainability (continued adoption) following the M-CHW implementation period(End of study (up to 5 years))
- Program Costs(End of study (up to 5 years))