Home Visiting for Low Income, Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Exclusive breastfeeding
研究概览
简要总结
In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive health care model that increases the opportunities for families to make healthy choices -- in their homes, schools & communities. The project's key element is: Lay community health workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to pregnant mothers & newly-delivered mothers who have agreed to participate in the research study.
Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare adherence.
Investigators will implement the study with 6 MMs, who will maintain an average caseload of 16 women each across an 18-month period. Each participant will be visited (or receive the intervention by telephone) twice per month.
Separate Assessment Team members will conduct assessments at: Baseline, within a week of birth of the target child, and 6 months from birth.
详细描述
After participant mothers have been recruited, screened, and consented into the study, each woman will be contacted by a member of the Assessment Team to schedule the in-home Baseline Assessment. The Baseline Assessment will take approximately 90 minutes to complete.
Follow-up Assessments will take place: within a week of delivery and 6 months after delivery. Interviews will be audio-recorded for quality assurance purposes. The domains of the Follow-up Assessments will be 1) maternal weight, height, and eating and exercise routines; 2) feeding routines, style, and frequency; 3) substance use; and 4) adherence to health care prenatally and postnatally, immunizations, and illnesses for mothers and babies. Secondarily, investigators will assess the mother's pregnancy, general health, mental health, social support, the father of the child, use of alternative medicine and health care, reproductive health, HIV, relationships and violence, baseline knowledge of antenatal health, baseline knowledge of delivery health, and baseline stated future plans.
All in-home interviews will take place in a private room or area of the participant's home. If an in-home interview is not practical or appropriate for any reason, the interviewer will conduct the interview at the Robert F. Kennedy Community Schools campus, UCLA, or another site.
Assessment team in-home interviews will be audio-recorded for quality assurance & supervision purposes. Telephone interviews will not be audio-recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older;
- •Currently pregnant;
- •Living in the Pico/Union Koreatown community;
- •Ability to provide informed consent;
- •Speaks English or Spanish
排除标准
- •Under 18 years of age;
- •Not currently pregnant;
- •Not living in the Pico/Union Koreatown community;
- •Unable to provide informed consent;
- •Does not speak English or Spanish
结局指标
主要结局
Exclusive breastfeeding
时间窗: Six months post-birth
Maternal BMI
时间窗: Six months post-birth
次要结局
- Alcohol, tobacco, and drug use in pregnancy(one week post-birth)
- Adherence to well-baby clinic visits(six months post-birth)
- World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference(six months post-birth)
- Adherence to prenatal clinic visits(one week post-birth)
研究者
Mary Jane Rotheram-Borus
Director, Global Center for Children and Families
University of California, Los Angeles