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临床试验/NCT06319807
NCT06319807已完成不适用

Using Digital Health Technologies to Prevent Obesity Among Infants of Parents Receiving Nutrition Assistance Benefits.

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年10月28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
69
试验地点
1
主要终点
Engagement - average text message completion rate

研究概览

简要总结

The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.

详细描述

Assess the feasibility and acceptability of a digital intervention aimed at increasing responsive infant feeding behaviors, beginning 1 month postpartum and continuing through 3-months postpartum, among a prospective cohort of women receiving WIC benefits.

Use qualitative methods to explore barriers and facilitators to participation in a digital infant feeding intervention among women receiving WIC benefits during early postpartum

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

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

  • •Aged ≥18 years
  • •as a smartphone and an email address
  • •willing to send and receive daily text messages
  • •can read and write in English
  • •child is <=6 weeks

排除标准

  • •participating in in a different research study that, in the opinion of the investigator, would conflict or would otherwise be too problematic if the subject were to participate in this study
  • •planning to leave North Carolina in the next 6 months
  • •subjects who do not have the capacity to give legally effective consent
  • •any medical or congenital condition that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate)

研究组 & 干预措施

Digital Health Intervention

Experimental

Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) tips to foster self-efficacy and skills training around responsive feeding - provide fully automated tailored feedback, which will include theory-driven content that aims to normalize common issues and problems, provide active solutions to feeding problems and affirm positive behavior. Participants will receive daily text messages for 12 weeks. Twice a week participants will be asked to self-monitor their adherence to goals in response to a text messaging prompt and will immediately receive tailored feedback and tips.

干预措施: Digital Health Intervention (Behavioral)

Safety Control

Active Comparator

Participants will receive tips to foster self-efficacy and skills training around infant safety. Participants will receive daily text messages for 12 weeks. Twice a week participants will be asked to self-monitor their adherence to safety goals in response to a text messaging prompt and will immediately receive tailored feedback and tips.

干预措施: Safety Control (Behavioral)

结局指标

主要结局

Engagement - average text message completion rate

时间窗: Week 12

Engagement will be assessed by reporting the average text message completion rate over the 12-week intervention period.

次要结局

  • Satisfaction Scores - Acceptability(Week 12)
  • Satisfaction Scores - Frequency(Week 12)
  • Satisfaction Scores - Timing(Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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