A Pilot Feasibility Study of Digitally Delivered Modules Focused on Preventing the Development of Obesity During the First Year of Life Within an Existing Statewide Home Visitation Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Child Weight for Length
研究概览
简要总结
The goal of this clinical trial is to determine feasibility and acceptability of a digitally-based obesity prevention intervention for mothers of infants participating in a home visitation program.
The main questions it aims to answer are:
- What impact does the digitally based obesity prevention intervention for parents have on children's weight?
- What impact does the digitally based obesity prevention intervention have on mothers' feeding practices, child sleep, and child screen time? Researchers will compare the digital intervention to home visiting standard curriculum to see if the intervention results in larger improvements.
Participants will view several digital modules including videos on feeding, activity and family topics over the course of 1 year. They will complete questionnaires at the beginning of the study and again at 4, 6 and 12 months and their child will be weighed and measured at each time point.
详细描述
The first 1,000 days (conception to age 2) have been deemed a critical period for obesity prevention yet, effective, sustainable efforts are lacking. Current home visitation programs (HVP) targeting at-risk families for other child development related issues are a potential innovative opportunity for early childhood obesity prevention. The overall goal of the project is to reduce the prevalence of overweight and obesity in children under the age of 1 year thereby reducing obesity rates of older children and adults in the long term. Prior pilot work by members of the research team demonstrated feasibility of embedding an early childhood obesity prevention (ECHO) program in an existing home visitation program (HVP+) during an infant's first year of life.
Five obesity-associated behaviors (i.e., breastfeeding, introduction to solids, limiting juice, sleep routines, screen time) were emphasized through brief interactive lessons utilizing behavior change strategies and an ecological approach by providing linkages to community resources that support healthy behaviors. The pilot program was well received by families, mothers breastfed longer, infants had fewer nocturnal awakenings, were less likely to receive juice, and had a lower weight-for-length (WFL) z-score at 12 months. However, there is a critical need for alternative and innovative, consistent, and sustainable digital delivery methods especially during times when face-to-face home visits are not feasible. Qualitative interviews were conducted with home visitors (n=27) from Florida's (FL) Maternal, Infant Early Childhood Home Visitation (MIECHV) Program and revealed that they were highly receptive to using digital learning with at-risk families.
The specific aims of the proposed research are to a) Develop, refine, and conduct usability testing of early childhood obesity prevention digital learning modules with mothers participating in FL MIECHV; and b) Conduct a pilot RCT of a 12 month digitally-enhanced early childhood obesity prevention intervention (HVP+E), with 50 mother-infant pairs (25 HVP+E/25 standard HVP) participating in FL MIECHV to determine feasibility and acceptability of the HVP+E intervention and study recruitment, implementation and evaluation protocols; and obtain data on preliminary efficacy of the intervention on children's WFL z-scores (primary outcome), maternal feeding practices, child sleep and screen time (secondary outcomes).
Mother-infant dyads (n=50) enrolled in the Maternal, Infant Early Childhood Home Visitation (MIECHV) Program parentally or within one month of giving birth will be randomized to receive either the standard home visitation program (HVP) or the digitally delivered obesity prevention-enhanced home visitation program (HVP+E) for 1 year. HVP+E content will also be expanded to support mothers in engaging fathers and other family members in target behaviors. Mother-infant dyads will be assessed at study entry and at 4, 6 and 12 months. If efficacious, the intervention has potential for public health impact through early childhood obesity prevention in an underserved population, and dissemination through home visitation programs nationwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in or eligible for home visiting program
- •Ages 16 years or older
- •Speaks and reads English
- •Has no chronic health condition affecting growth or development
- •Has a singleton birth > 37 weeks gestation.
排除标准
- •Child has a major malformation
- •Child admitted to the NICU
- •Child considered small for gestation age (SGA) and/or have a low birth weight (<2500 gms)
- •Mother has a significant maternal morbidity (e.g. cancer) or hospitalization for psychiatric disorder in past 6 months
- •Extended hospital stay for mom or infant > 5 days
- •Unable to speak and read English.
研究组 & 干预措施
standard home visiting curriculum
standard home visiting program for parents
干预措施: Home visiting curriculum (Behavioral)
Digital intervention
digitally delivered childhood obesity prevention intervention for parents
干预措施: digital intervention + home visiting curriculum (Behavioral)
结局指标
主要结局
Child Weight for Length
时间窗: 0, 4, 6, 12 months
Weight for Length (WFL) z-score. A z-score of 0 indicates a child is a the median for WFL. Scores above 0 indicate that a child has a higher WFL and may be at risk for overweight or obesity. Scores below 0 indicate that a child has a lower WFL and may be at risk for undernutrition.
次要结局
- Brief Infant Sleep Questionnaire(0, 4, 6 and 12 months)
- Postnatal Edinburgh Depression Scale(0, 4, 6 and 12 months)
- Baby's Basic Needs Questionnaire (BBNQ)(0, 4, 6, and 12 months)
- Feeding behaviors of parents (breastfeeding, timing of juice and solid food introduction)(0, 4, 6 and 12 months)
- Family Social Support Questionnaire(0, 4, 6 and 12 months)
- Perceived Stress Scale(0, 4, 6 and 12 months)
- Structure and Control in Parent Feeding Questionnaire (SCFQ)(0, 4, 6, 12 months)
- Parental obesity prevention knowledge, attitudes, and behaviors(From date of randomization until date of completion of the digital modules, assessed up to 1 year.)
- Dietary Screener Questionnaire(0, 4, 6 and 12 months)
- Activity and Screen time(0, 4, 6 and 12 months)