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临床试验/NCT01977105
NCT01977105已完成不适用

Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年9月1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
9
试验地点
1
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.

研究组 & 干预措施

Pilot Intervention Group

Experimental

Mothers who are screened and determined to be eligible for this single-group pilot study will be enrolled along with their infants in the Grow Together peer group intervention.

干预措施: Grow Together peer group (Behavioral)

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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