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临床试验/NCT05990439
NCT05990439已完成不适用

Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain

Florida International University2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
2
主要终点
Diet Quality

研究概览

简要总结

This study will test the Baby-Feed web platform among 160 parents with infants aged 1-3 months at the time of enrollment and follow them through their 9-month well-child visit (about a total of 6 months) using a mixed-methods approach (randomized control trial with qualitative interviews).

详细描述

This study will test the Baby-Feed web platform among 160 parents with infants aged 1-3 months at the time of enrollment and follow them through their 9-month well-child visit (about a total of 6 months) using a mixed-methods approach (randomized control trial with qualitative interviews). This age range was chosen as this is the period in which parents initiate and continue complementary foods in their infants' diets. Procedures: Participants randomized to the intervention arm (n=80) will have full access to the Baby-Feed web application and receive automated weekly text messages to complement the information received in Baby-Feed and to remind them to access the web application. Within the Baby-Feed platform, the intervention arm will assess the online infant FFQ to complete it at the required intervals (before the 4-month, 6-month, and 9-month well-child visits) and receive automatic feedback for obtaining recommended intake of food groups as well as input bi-weekly tracking goals. They will also record their infant's weight and length as provided from the well-child visits, which will plot on the WHO CDC 0-24 months growth chart and provide feedback to their infant's growth pattern. Caregivers will also have access to educational resources to aid them in reading and viewing appropriate infant guidance. Participants randomized to the control arm (n=80) will have access to certain components of the Baby-Feed web application, such as the online infant FFQ to complete it at the same intervals (before the 4-month, 6-month, and 9-month well-child visits) and infant's weight and length as recorded in the well-child visits, but without any automatic results or feedback. Risks and anticipated benefits: It is anticipated that this trial will have minimal risks as it is self-reported data only. Anticipated benefits include caregivers receiving dietary and weight gain guidance during the study which may assist with optimal nutritional and weight status. The importance of the knowledge that may reasonably be expected to result: The importance of this knowledge could lead to public use of the Baby-Feed web application leads to improvements in diet and weight gain during this critical time of growth and by potentially becoming a routine and accessible tool for clinicians to recommend their patients to support optimal growth and development for infants

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 (Participant, Investigator)

盲法说明

randomization, assignment of arms, assessments

入排标准

年龄范围
1 Month 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 1-3 months old at time of enrollment, term healthy infant, any weight status, parent/family member must be primary caretakers, have internet access, agree to receive text messaging service for communication and reminders, willing to participate for full study duration, and English or Spanish language literate.

排除标准

  • Infants with special diets, preterm birth (<37 weeks), caregiver inability to consent to participate, unwillingness to be randomized, and unable to read in English or Spanish.

结局指标

主要结局

Diet Quality

时间窗: 9 months

It will be analyzed from the responses to the infant FFQ using the Diet Quality Index Score (DQIS)

Rate of weight gain

时间窗: 9 months

It will be analyzed from the plotted weight and length as recorded by caregivers in the WHO gender-specific growth chart table in Baby-Feed after each well-child visit (4, 6, and 9 months) to calculate weight-for-length z-score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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