Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Intervention Acceptability Survey
研究概览
简要总结
This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.
详细描述
This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities.
In this study, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Women age 18 years and older
- •Enrolled in Medicaid at the time of study enrollment
- •Overweight or obese (BMI >= 25, calculated using self-reported pre-pregnancy height and weight)
- •Subjects able to speak, read and write in English
- •Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site
- •Received prenatal care
- •Own a smartphone with both a data and text plan
- •Able to use their phone to obtain photographs and videos prior to enrollment
排除标准
- •Cannot provide consent.
- •Non-English speaking.
- •Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression
- •Diagnosed with gestational diabetes during pregnancy with their newborn
- •Had a multiple pregnancy.
- •Premature delivery (before 37 weeks) of their newborn.
- •Have a newborn who was hospitalized in the Neonatal Intensive Care Unit (NICU) for one week or longer.
结局指标
主要结局
Intervention Acceptability Survey
时间窗: Study end (approximately 2 months)
Satisfaction with the overall intervention will be assessed for mothers using a standard survey. Subjects will be asked a series of open-ended and Likert-scaled questions.
Study population eligibility and interest
时间窗: Study end (approximately 2 months)
* Proportion of all mothers contacted who meet enrollment criteria * Proportion of mothers meeting enrollment criteria who enroll These proportions will be calculated using study recruitment records.
Participant engagement
时间窗: Study end (approximately 2 months)
* Proportion of enrolled mother-infant dyads that comply with intervention participation requirements * Proportion of enrolled mother-infant dyads that complete each weekly module activity * Proportion of enrolled mother-infant dyads that complete each study measure * Number and type of each participant's Facebook group interactions per week (posts, comments, "Likes") * Frequency, type, and content of each contact between moderator/study staff and each participant This study process data will be obtained from the Facebook group and study records at study end.
Week 1 Curriculum Module Acceptability Survey
时间窗: 1 week (approximately)
Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 2 Curriculum Module Acceptability Survey
时间窗: 2 weeks (approximately)
Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 3 Curriculum Module Acceptability Survey
时间窗: 3 weeks (approximately)
Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 4 Curriculum Module Acceptability Survey
时间窗: 4 weeks (approximately)
Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 5 Curriculum Module Acceptability Survey
时间窗: 5 weeks (approximately)
Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 6 Curriculum Module Acceptability Survey
时间窗: 6 weeks (approximately)
Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 7 Curriculum Module Acceptability Survey
时间窗: 7 weeks (approximately)
Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 8 Curriculum Module Acceptability Survey
时间窗: 8 weeks (approximately)
Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
次要结局
未报告次要终点