Obesity, ChildhoodSTORYNCT05994924
Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
A study testing Educational Handout, Video Series and Group Discussion Sessions in people with Obesity, Childhood, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Educational Handout, Video Series and Group Discussion Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Childhood
- Being tested
- Educational Handout, Video Series, Group Discussion Sessions
- 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
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational HandoutBehavioural
Educational handout describing responsive feeding practices.
Video SeriesBehavioural
Videos geared toward responsive feeding practices.
Group Discussion SessionsBehavioural
Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.
| Study group | Role | What they receive |
|---|---|---|
| Handout Only | Active comparator | Parents in this group receive an educational handout at the baseline visit. Receives: Behavioral: Educational Handout |
| Online-Only Video Series | Active comparator | Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward. Receives: Behavioral: Video Series |
| Group Sessions | Active comparator | Parents will participate in 2 weekly group sessions with video viewing and group discussion. Receives: Behavioral: Video Series; Behavioral: Group Discussion Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Parents Approached
Number of parents who are approached for participation at 3 primary care offices.
Measured: Baseline
Number of Parents Consented
Number of parents that consented to participating in the study.
Measured: Baseline
Number of Parents Who Viewed Videos Provided by Provider
tracking the number of videos viewed by each parent
Measured: Month 2
Number of Parents Who Complete In-Person Group Sessions
number of parents who complete two in-person group sessions
Measured: Month 2
Parent Acceptance of Intervention - Percent of Parents
Percent of parents who responded that the intervention was acceptable or completely acceptable to them
Measured: 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
Measured: Month 4
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 4
Fidelity of Intervention Delivery - Percentage of Key Points
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.
Measured: month 4
Facilitator Self-Competence Percentage - Percentage of Facilitators
Percentage of facilitators who respond Agree or Strongly Agree to survey question about perceived self-competence
Measured: 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
Measured: 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".
Measured: 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.
Measured: month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start6 Feb 2024
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Callie Brown, MD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994924
- Sponsor's protocol ID
- IRB00078071
- Acronym
- STORY
- Status last verified
- May 2024
- First submitted
- 9 Aug 2023
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
- ClinicalTrials.gov ID
- NCT05994924
- Acronym / sponsor ID
- STORY / IRB00078071
- Conditions
- Obesity, Childhood
- Keywords
- obesity, young children, feeding practices, obesity prevention, obesity intervention, child feeding questionnaire, satiety responsiveness, food responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Handout Only | Active comparator | Behavioral: Educational HandoutParents in this group receive an educational handout at the baseline visit. |
| Online-Only Video Series | Active comparator | Behavioral: Video SeriesParents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward. |
| Group Sessions | Active comparator | Behavioral: Video Series, Behavioral: Group Discussion SessionsParents will participate in 2 weekly group sessions with video viewing and group discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational HandoutEducational handout describing responsive feeding practices. | Behavioural | Handout Only |
| Video SeriesVideos geared toward responsive feeding practices. | Behavioural | Group Sessions, Online-Only Video Series |
| Group Discussion SessionsGroup discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education. | Behavioural | Group Sessions |
Primary outcome
Number of Parents Approached
Time frame: Baseline
Number of parents who are approached for participation at 3 primary care offices.
Number of Parents Consented
Time frame: Baseline
Number of parents that consented to participating in the study.
Number of Parents Who Viewed Videos Provided by Provider
Time frame: Month 2
tracking the number of videos viewed by each parent
Number of Parents Who Complete In-Person Group Sessions
Time frame: Month 2
number of parents who complete two in-person group sessions
Parent Acceptance of Intervention - Percent of Parents
Time frame: Month 4
Percent of parents who responded that the intervention was acceptable or completely acceptable to them
Facilitator Acceptance of Intervention - Percent of Facilitators
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
12 secondary outcomes
Mean Pressure to Eat Score (Child Feeding Questionnaire)
Time frame: Month 4
Mean Restriction Score (Child Feeding Questionnaire)
Time frame: Month 4
Mean Satiety Responsiveness Score
Time frame: Month 4
Mean Food Responsiveness Score
Time frame: Month 4
Mean Enjoyment of Food Score
Time frame: Month 4
Mean of Families Using Structured Mealtime Practices
Time frame: Month 4
Percentage of Families Eating Family Meals at Least 3 Times Per Week
Time frame: Month 4
Fidelity of Intervention Delivery - Percentage of Key Points
Time frame: month 4
Facilitator Self-Competence Percentage - Percentage of Facilitators
Time frame: month 4
Fidelity of Receipt - Percentage of Parents
Time frame: month 4
Percentage of Parents Who Identified a Goal
Time frame: month 4
Enactment Percentage
Time frame: month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Callie Brown, MD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Handout, Video Series and Group Discussion Sessions in people with Obesity, Childhood, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Parents Approached (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.