Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT05994924
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Educational handout describing responsive feeding practices.
Videos geared toward responsive feeding practices.
Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.
Time frame: Baseline
Number of parents who are approached for participation at 3 primary care offices.
Time frame: Baseline
Number of parents that consented to participating in the study.
Time frame: Month 2
tracking the number of videos viewed by each parent
Time frame: Month 2
number of parents who complete two in-person group sessions
Time frame: Month 4
Percent of parents who responded that the intervention was acceptable or completely acceptable to them
Time frame: 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
Time frame: Month 4
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.
Time frame: Month 4
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.
Time frame: Month 4
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.
Time frame: Month 4
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.
Time frame: Month 4
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.
Time frame: Month 4
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.
Time frame: Month 4
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.
Time frame: month 4
Study staff will complete Evaluation Checklist of 9 essential key points communicated during each group session to determine intervention delivery. Out of the possible 18 key points the percentage of key points communicated during the sessions will be tallied.
Time frame: month 4
Percentage of facilitators who respond Agree or Strongly Agree to survey question about perceived self-competence
Time frame: month 4
Percentage of parents who respond Agree or Strongly Agree to survey question about whether the video content was relevant
Time frame: month 4
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".
Time frame: month 4
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.
Time frame: month 4
Information collected from semi-structured interviews. Thematic analysis performed and coded by two independent investigators. Representative quotes will be recorded, and transcript codes will be grouped into similar categories. Investigators will interpret themes and sub-themes from these categories.
Time frame: 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
Time frame: month 4
The 10-item questionnaire is measured on a 5-point Likert scale (ranging from 1=never to 5=always). The demandingness and responsiveness scores are used to categorize parent feeding style into one of four categories: authoritative, authoritarian, indulgent, and uninvolved styles.
Wake Forest University Health Sciences
Other
A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
Acronym: STORY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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