Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
The goal of this clinical trial is to test an online program that teaches healthy habits during pregnancy and infant to prevent early child obesity in Latino families. Specifically, this pilot trial will determine how well we can deliver and test the effects of the program, and how acceptable it is to participants.
The main question it aims to answer are:
• Is a randomized controlled trial of StEP OUT versus infant safety education control feasible to conduct and acceptable to participants? Researchers will compare StEP OUT to infant safety education control to see if participants enroll in and engage with the program, complete surveys, and learn the content we are teaching.
Participants will:
- Be assigned to receive StEP OUT or Infant Safety Education
- If receiving StEP OUT, they will participant in group text chats and video calls
- If receiving Infant Safety Education, they will receive periodic text messages with helpful links and tips
- Respond to periodic surveys
详细描述
Our objective is to conduct a pilot RCT to evaluate the acceptability, feasibility, and preliminary effectiveness of StEP OUT.
Hypothesis
The intervention and control conditions of StEP OUT will be acceptable to families and feasible, as measured by recruitment, randomization, retention, usability, and fidelity. H3b (exploratory): Families exposed to StEP OUT will have improved obesity-related outcomes (knowledge, styles, practices, and infant adiposity) compared to controls.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant with singleton of 24 to 32 weeks estimated gestational age
- •Self-identify as Hispanic/Latinx
- •Speak fluent English or Spanish
- •At least 18 years of age
- •Has a phone or device to participate in video calls
- •Receiving or eligible to receive New York State Medicaid benefits
排除标准
- •Diminished mental capacity
- •Serious medical or psychiatric illness
- •Fetal condition expected to substantially influence infant feeding (anatomic abnormality, such as cleft lip/palate or one that will require surgery within the first six months of life, chromosomal abnormality, such as Down's syndrome or other trisomy, etc.)
研究组 & 干预措施
StEP OUT
Online nutrition education and parenting support with group chat.
干预措施: StEP OUT (Behavioral)
Infant Safety Education
Periodic text messages with links to prenatal and infant health and safety resources.
干预措施: Infant Safety Education (Behavioral)
结局指标
主要结局
Acceptability
时间窗: From enrollment through the end of the study after child age 6 months
We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.
次要结局
- Feasibility(From enrollment to study completion after infant age 6 months.)