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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Educational Handout; Behavioral: Video Series; Behavioral: Group Discussion Sessions

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
Percentage of Parents that are categorized into four feeding styles (Caregiver's Feeding Styles Questionnaire Reduced Version)	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.	month 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Analysis	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.	month 4

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Callie Brown, MD, MPH, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: obesity; young children; obesity prevention; obesity intervention; food responsiveness; satiety responsiveness; feeding practices; child feeding questionnaire; family meal frequency questionnaire; structure of family meals
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB00078071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No