Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a pilot randomized trial to assess feasibility and acceptability of STORY. The study will recruit 30 parents. Parents will complete a questionnaire and dyad's heights and weights will be measured. Families 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 family's 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

Official Title
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A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Educational Handout
* Behavioral: Video Series
* Behavioral: Group Discussion Sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Handout Only<br>Parents in this group receive an educational handout at the baseline visit. | Behavioral: Educational Handout<br>* Educational handout describing responsive feeding practices.<br>|
| Active Comparator: Online-Only Video Series<br>Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward. | Behavioral: Video Series<br>* Videos geared toward responsive feeding practices.<br>|
| Active Comparator: Group Sessions<br>Parents will participate in 2 weekly group sessions with video viewing and group discussion. | Behavioral: Video Series<br>* Videos geared toward responsive feeding practices.<br>Behavioral: Group Discussion Sessions<br>* Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Parents Approached | Number of parents who are approached for participation at 3 primary care offices. | Baseline | 
| Number of Parents Consented | Number of parents that consented to participating in the study. | Baseline | 
| Number of Parents who Viewed Videos Provided by Provider | tracking the number of videos viewed by each parent | Month 2 | 
| Number of Parents who Complete In-Person Group Sessions | tracking the number of sessions attended by each parent | Month 2 | 
| Parent Acceptance of Intervention - Percent of parents | 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 | Month 4 | 
| Provider Acceptance of Intervention - Percent of providers | 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 | Month 4 | 
| Facilitator Acceptance of Intervention - Percent of facilitators | 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 | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pressure to eat score (Child Feeding Questionnaire) | The 4-item subscale from the Child Feeding Questionnaire, called Pressure to Eat, measures parents' tendency to pressure their children to eat more food, typically at mealtimes. Possible scores range from 1-5, with higher scores indicating greater severity of parents' tendency to pressuring their children to eat more food. Information to be utilized in a future larger study. | Month 4 | 
| Mean restriction score (Child Feeding Questionnaire) | The 8-item subscale from the Child Feeding Questionnaire, called Restriction, measures the extent to which parents restrict their child's access to foods. Possible scores range from 1-5, with higher scores indicating greater severity of parents restricting their child's access to foods. Information to be utilized in a future larger study. | Month 4 | 
| Mean satiety responsiveness score | Mean satiety responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores indicating higher self-regulation. Information to be utilized in a future larger study. | Month 4 | 
| Mean food responsiveness score | Mean food responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study. | Month 4 | 
| Mean enjoyment of food score | Mean enjoyment of food score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study. | Month 4 | 
| Mean of families using structured mealtime practices | The 10-item Structure of Family Meals subscale from the Meals in our Household Questionnaire measures how often families spend their mealtimes in a specific setting. Possible scores range from 0-4, with higher scores indicating higher occurrences of specific mealtime settings. Information to be utilized in a future larger study. | Month 4 | 
| Percentage of families eating family meals at least 3 times per week | Percentage of families eating family meals at least 3 times per week using Family Meal Frequency Questionnaire which asks how many times a week the family eats dinner together, both at home and at a restaurant. Information to be utilized in a future larger study. | Month 4 | 
| Fidelity of intervention delivery - Percentage of key points | Study staff will complete Evaluation Checklist of key points communicated during each session to determine intervention delivery - Percentage of key points communicated during the sessions from the Evaluation Checklist | month 4 | 
| Facilitator Self-Competence Percentage - Percentage of facilitators | Facilitator self-competence percentage will be collected from facilitators responding to an open-ended question after each session to evaluate the strong and weak points of their own delivery - : Percentage of facilitators who respond agree or strongly agree to survey question about perceived self-competence | month 4 | 
| Fidelity of Receipt - : Percentage of parents | Percentage of parents who respond agree or strongly agree to survey question about whether the video content was relevant | month 4 | 
| Percentage of Parents who Identified a Goal | Receipt will be collected through the follow-up survey. Information collected includes a response of yes or no by parent expert assessment of whether the parent identified an attainable, specific, and measurable goal. Percentage of parents who identified a goal will include the percentage who answer yes. | month 4 | 
| Enactment percentage | Enactment will be collected through the follow-up survey. Enactment Percentage will include those considered by an expert to have made a specific and measurable change in feeding practices. | month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, young children, feeding practices, obesity prevention, obesity intervention, child feeding questionnaire, satiety responsiveness, food responsiveness, family meal frequency questionnaire, structure of family meals