A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Parents Consented
研究概览
简要总结
The goal of this qualitative trial study is to assess the usefulness and acceptability of the intervention in diverse clinical and community settings. The main questions it aims to answer are:
- How many parents were approached and consented to participate?
- How many parents viewed the videos via link versus viewed the video with a discussion in group sessions?
- How did parents feel about the process of being recruited and interventions that they participated in?
- How did the providers feel about the intervention recruitment and delivery?
- How did the facilitators feel about their delivery of the material? Participants will complete a survey and an interview after completing second part of the intervention.
Researchers will compare handout, online-only video, and group class interventions to see if an intervention delivery is useful and accepted by parents or providers.
详细描述
This is a pilot randomized trial to assess feasibility and acceptability of STORY. The study will recruit 30 parents. Parents will be randomized to the control group or 1 of 2 intervention delivery approaches (IA). Parents will be given a handout (controls), links to the videos to watch independently (IA 1), or information on how they will be contacted to schedule their intervention sessions (IAs 2). After 2 video/sessions, all parents will complete a written survey assessing their experience with the intervention and any change same at home; the written survey will reassess baseline measures. Intervention parents will also complete a semi-structured interview to assess the experience with the STORY trial.
Sub aim 2a: Feasibility: number of parents approached, number of parents consented Sub aim 2b: Adherence: number of parents who complete videos or sessions Sub aim 2c: Acceptability to parents and providers
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of 2-4 year old child
- •Is at least 18 years old
- •Participant can read and write English
- •The participant's child has no medical conditions that affect development, feeding, or growth
排除标准
- •Participant is not a parent of a 2-4 year old child
- •Parent is less than 18 years old
- •Parent can not read and write English
- •Participant's child has a medical condition that affects development, feeding, or growth
- •Family/household member participating in study
研究组 & 干预措施
Group Sessions
Parents will participate in 2 weekly group sessions with video viewing and group discussion.
干预措施: Video Series (Behavioral)
Group Sessions
Parents will participate in 2 weekly group sessions with video viewing and group discussion.
干预措施: Group Discussion Sessions (Behavioral)
Handout Only
Parents in this group receive an educational handout at the baseline visit.
干预措施: Educational Handout (Behavioral)
Online-Only Video Series
Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward.
干预措施: Video Series (Behavioral)
结局指标
主要结局
Number of Parents Consented
时间窗: Baseline
Number of parents that consented to participating in the study.
Facilitator Acceptance of Intervention - Percent of facilitators
时间窗: Month 4
Measure facilitator acceptability using semi-structured interviews - Percent of facilitators who respond on the survey that the intervention was acceptable or completely acceptable to them
Number of Parents Approached
时间窗: Baseline
Number of parents who are approached for participation at 3 primary care offices.
Number of Parents who Viewed Videos Provided by Provider
时间窗: Month 2
tracking the number of videos viewed by each parent
Number of Parents who Complete In-Person Group Sessions
时间窗: Month 2
tracking the number of sessions attended by each parent
Provider Acceptance of Intervention - Percent of providers
时间窗: Month 4
Measure provider acceptability using a short survey - Percent of providers who respond on the survey that the intervention was acceptable or completely acceptable to them
Parent Acceptance of Intervention - Percent of parents
时间窗: Month 4
Measure parent acceptability of intervention using brief survey and semi-structured interview responses - Percent of parents who respond on the survey that the intervention was acceptable or completely acceptable to them
Number of Parents Who Viewed Videos Provided by Provider
时间窗: Month 2
tracking the number of videos viewed by each parent
Number of Parents Who Complete In-Person Group Sessions
时间窗: Month 2
number of parents who complete two in-person group sessions
Parent Acceptance of Intervention - Percent of Parents
时间窗: Month 4
Percent of parents who responded that the intervention was acceptable or completely acceptable to them
Facilitator Acceptance of Intervention - Percent of Facilitators
时间窗: Month 4
Measure facilitator acceptability using semi-structured interviews - Percent of facilitators who respond on the survey that the intervention was acceptable or completely acceptable to them
次要结局
- Mean food responsiveness score(Month 4)
- Percentage of families eating family meals at least 3 times per week(Month 4)
- Enactment percentage(month 4)
- Mean pressure to eat score (Child Feeding Questionnaire)(Month 4)
- Mean satiety responsiveness score(Month 4)
- Percentage of Parents that are categorized into four feeding styles (Caregiver's Feeding Styles Questionnaire Reduced Version)(month 4)
- Fidelity of Receipt - : Percentage of parents(month 4)
- Mean restriction score (Child Feeding Questionnaire)(Month 4)
- Fidelity of intervention delivery - Percentage of key points(month 4)
- Facilitator Self-Competence Percentage - Percentage of facilitators(month 4)
- Percentage of Parents who Identified a Goal(month 4)
- Mean enjoyment of food score(Month 4)
- Mean of families using structured mealtime practices(Month 4)
- Mean Pressure to Eat Score (Child Feeding Questionnaire)(Month 4)
- Mean Restriction Score (Child Feeding Questionnaire)(Month 4)
- Mean Satiety Responsiveness Score(Month 4)
- Mean Food Responsiveness Score(Month 4)
- Mean Enjoyment of Food Score(Month 4)
- Mean of Families Using Structured Mealtime Practices(Month 4)
- Percentage of Families Eating Family Meals at Least 3 Times Per Week(Month 4)
- Fidelity of Intervention Delivery - Percentage of Key Points(month 4)
- Facilitator Self-Competence Percentage - Percentage of Facilitators(month 4)
- Fidelity of Receipt - Percentage of Parents(month 4)
- Percentage of Parents Who Identified a Goal(month 4)
- Enactment Percentage(month 4)