Multi-site Trial Using Short Mobile Messages (SMS) to Improve Infant Weight in Low-income Minorities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Excessive weight gain
研究概览
简要总结
The goals of this multi-site clinical trial are to pilot test weekly SMS sent to parents/caregivers of infants to improve feeding practices and decrease excessive weight gain in infants who are participants of the Women, Infants and Children (WIC) program in Puerto Rico and Hawaii. The intervention consists of weekly SMS for 4 months to reinforce the feeding messages provided by WIC.
详细描述
The goals of this multi-site clinical trial are to pilot test weekly SMS sent to parents/caregivers of infants to improve feeding practices and decrease excessive weight gain in infants who are participants of the WIC program in two distinct locations, Puerto Rico and Hawaii; to assess acceptability and practicality of the intervention; and to assess acceptability of collecting blood spots in future studies. The investigators will recruit a convenience sample of parent/caregivers of infants 0-2 months participating in the WIC program in Puerto Rico and Hawaii to send weekly SMS for 4 months. The weekly messages will focus on reinforcing the breastfeeding messages provided by WIC, preventing overfeeding, delaying introduction of solid foods, and delaying and reducing baby juice consumption, which are key issues in low-income populations. Participants will complete validated questionnaires and anthropometry before and after the trial and results will be compared to the control group (no messages). Participants will also answer short questions by SMS at different points and an interview at the end of the trial to assess the SMS. The investigators will assess how many participants agree to collect blood spots in their infants in future studies.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver age 18 years and older
- •owner of a mobile phone with unrestricted SMS capability
- •responsible for the care of the infant and willing to actively participate for the full duration of the study.
排除标准
- •infants with special diets
- •infants with limited mobility
- •pre-term birth (<37 weeks)
- •small or large for gestational age (birthweight <10th or >90th p)
- •inability to consent to participate in the study
- •unwillingness to be randomized and not being able to read
研究组 & 干预措施
Nutrition messages
The intervention will focus on reinforcing the WIC breastfeeding messages, preventing overfeeding (i.e. using spoon to feed baby, not adding baby food or cereal to bottle, not placing their babies to sleep with a bottle, feeding their babies without distractions, etc), delaying introduction of solid foods, and delaying and reducing baby juice consumption. Constructs in the transtheoretical model such as self-efficacy and decisional balance will be used to address key determinants of behavior change to ensure relevance to the audience, and will target individuals both at the earlier and later stages of change. The messages are written at a grade 5 level in Spanish (PR site) and English (Hawaii site) and will be sent on different days and times of the week.
干预措施: SMS (Behavioral)
General health messages
The control group will receive weekly SMS about general infant's health issues, such as placing the infant on his/her back to sleep, the timeline for immunizations, the proper use of car seats, asthma and other respiratory conditions common among small children, and other health information relevant to infants. The investigators will follow the same protocol (schedule, length, language, etc.) as for the intervention messages.
干预措施: SMS (Behavioral)
结局指标
主要结局
Excessive weight gain
时间窗: 0-6 months
Infant weight-for-length percentile will be calculated using the World Health Organization growth charts, as recommended by the Center for Disease Control and Prevention (CDC) for this age. Excessive weight will be categorized as ≥90th percentile
次要结局
- Acceptability of the intervention - from short SMS(0-6 months)
- Acceptability of the intervention - from exit interview(0-6 months)
- Acceptability of collecting blood spots(0-2 months)
- Practicality of the intervention - from short SMS(0-6 months)
- Practicality of the intervention - from exit interview(0-6 months)
- Infant food frequency(0-6 months)
- General infant feeding practices(0-6 months)
研究者
Cristina Palacios
Associate Professor
University of Puerto Rico