Pilot Adaptive Tool To Encourage Risk Reduction in iNfancy (PATTERN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire
研究概览
简要总结
The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. The study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life. Parents will receive information about changes and some tools and materials to take home with them. Some parents may receive phone calls between visits as well. The study takes place from soon after birth through the infant's age of 9 months. The estimated total time of interaction between the study staff and parents during the study period is 4 hours.
详细描述
As this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks
排除标准
- •non-English-speaking; infant with serious disease or disorder affecting growth and nutrition
结局指标
主要结局
Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire
时间窗: 3 to 6 months after baseline assessment
Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied
Percentage of Successful Contacts With Families Via Telephone and/or in Clinic
时间窗: 3 to 6 months after baseline assessment
Number of successful contacts with families divided by number of attempts to contact by research staff x 100
次要结局
- Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age(3 to 6 months after baseline assessment)
- Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age(3 to 6 months after baseline assessment)
- Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age(3 to 6 months after baseline assessment)