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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05994924
Acronym
STORY
Enrollment
60
Registered
2023-08-16
Start date
2024-02-06
Completion date
2024-09-12
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

obesity, young children, feeding practices, obesity prevention, obesity intervention, child feeding questionnaire, satiety responsiveness, food responsiveness, family meal frequency questionnaire, structure of family meals

Brief summary

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

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

Interventions

Educational handout describing responsive feeding practices.

BEHAVIORALVideo Series

Videos geared toward responsive feeding practices.

BEHAVIORALGroup Discussion Sessions

Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Parents ApproachedBaselineNumber of parents who are approached for participation at 3 primary care offices.
Number of Parents ConsentedBaselineNumber of parents that consented to participating in the study.
Number of Parents Who Viewed Videos Provided by ProviderMonth 2tracking the number of videos viewed by each parent
Number of Parents Who Complete In-Person Group SessionsMonth 2number of parents who complete two in-person group sessions
Parent Acceptance of Intervention - Percent of ParentsMonth 4Percent of parents who responded that the intervention was acceptable or completely acceptable to them
Facilitator Acceptance of Intervention - Percent of FacilitatorsMonth 4Measure facilitator acceptability using semi-structured interviews - Percent of facilitators who respond on the survey that the intervention was acceptable or completely acceptable to them

Secondary

MeasureTime frameDescription
Mean Pressure to Eat Score (Child Feeding Questionnaire)Month 4The 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.
Mean Restriction Score (Child Feeding Questionnaire)Month 4The 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.
Mean Satiety Responsiveness ScoreMonth 4Mean 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.
Mean Food Responsiveness ScoreMonth 4Mean 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.
Mean Enjoyment of Food ScoreMonth 4Mean 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.
Mean of Families Using Structured Mealtime PracticesMonth 4The 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.
Percentage of Families Eating Family Meals at Least 3 Times Per WeekMonth 4Percentage 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.
Fidelity of Intervention Delivery - Percentage of Key Pointsmonth 4Study 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.
Facilitator Self-Competence Percentage - Percentage of Facilitatorsmonth 4Percentage of facilitators who respond Agree or Strongly Agree to survey question about perceived self-competence
Fidelity of Receipt - Percentage of Parentsmonth 4Percentage of parents who respond Agree or Strongly Agree to survey question about whether the video content was relevant
Percentage of Parents Who Identified a Goalmonth 4Receipt 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".
Enactment Percentagemonth 4Enactment 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCallie Brown, MD, MPH

Wake Forest University Health Sciences

Participant flow

Recruitment details

Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.

Pre-assignment details

Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
60 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
High School Education
High school graduate
15 Participants
High School Education
Less than high school diploma
11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
10 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
8 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 200 / 20
other
Total, other adverse events
0 / 200 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 200 / 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026