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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:
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Handout Only | Active Comparator | Parents in this group receive an educational handout at the baseline visit. |
|
| 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. |
|
| Group Sessions | Active Comparator | Parents will participate in 2 weekly group sessions with video viewing and group discussion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Handout | Behavioral | Educational handout describing responsive feeding practices. |
|
| 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 | number of parents who complete two in-person group sessions | Month 2 |
| Parent Acceptance of Intervention - Percent of Parents | Percent of parents who responded 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Callie Brown, MD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.
Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Handout Only | Parents in this group receive an educational handout at the baseline visit. Educational Handout: Educational handout describing responsive feeding practices. |
| FG001 | Online-Only Video Series | Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward. Video Series: Videos geared toward responsive feeding practices. |
| FG002 | Group Sessions | Parents will participate in 2 weekly group sessions with video viewing and group discussion. Video Series: Videos geared toward responsive feeding practices. Group Discussion Sessions: Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Handout Only | Parents in this group receive an educational handout at the baseline visit. Educational Handout: Educational handout describing responsive feeding practices. |
| BG001 | Online-Only Video Series |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Parents Approached | Number of parents who are approached for participation at 3 primary care offices. | Posted | Number | parents approached | Baseline |
|
|
baseline through month 4
Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Handout Only | Parents in this group receive an educational handout at the baseline visit. Educational Handout: Educational handout describing responsive feeding practices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Callie Brown, MD | Atrium Health Wake Forest Baptist | 336.716.4987 | Callie.L.Brown@wfusm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2023 | Mar 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2024 | Sep 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Video Series | Behavioral | Videos geared toward responsive feeding practices. |
|
| Group Discussion Sessions | Behavioral | Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education. |
|
| 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 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. | 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 | 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 |
| 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 |
| Caregiver's Feeding Styles Questionnaire Score | 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 |
Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward.
Video Series: Videos geared toward responsive feeding practices.
| BG002 | Group Sessions | Parents will participate in 2 weekly group sessions with video viewing and group discussion. Video Series: Videos geared toward responsive feeding practices. Group Discussion Sessions: Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| High School Education | Count of Participants | Participants |
|
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| Primary | Number of Parents Consented | Number of parents that consented to participating in the study. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Primary | Number of Parents Who Viewed Videos Provided by Provider | tracking the number of videos viewed by each parent | Videos were only made available to parents in the online-only video series arm | Posted | Count of Participants | Participants | Month 2 |
|
|
|
| Primary | Number of Parents Who Complete In-Person Group Sessions | number of parents who complete two in-person group sessions | group sessions were not offered to the Handout Only and Online-Only arms | Posted | Count of Participants | Participants | Month 2 |
|
|
|
| Primary | Parent Acceptance of Intervention - Percent of Parents | Percent of parents who responded that the intervention was acceptable or completely acceptable to them | Posted | Number | percent of parents | Month 4 |
|
|
|
| Primary | 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 | Posted | Number | percent of facilitators | Month 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | Month 4 |
|
|
|
| Secondary | 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. | Key points communicated only applied to the Group Sessions arm | Posted | Number | percentage of key points communicated | month 4 |
|
|
|
| Secondary | Facilitator Self-Competence Percentage - Percentage of Facilitators | Percentage of facilitators who respond Agree or Strongly Agree to survey question about perceived self-competence | Posted | Number | percentage of facilitators | month 4 |
|
|
|
| Secondary | 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 | Posted | Number | percentage of parents | month 4 |
|
|
|
| Secondary | 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". | This outcome measure only applied to the Group Sessions arm. | Posted | Number | percentage of parents | month 4 |
|
|
|
| Secondary | 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. | This outcome measure only applied to the Group Sessions arm. | Posted | Number | percentage of parents | month 4 |
|
|
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| Other Pre-specified | 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. | Not Posted | month 4 | Participants |
| Other Pre-specified | 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 | Not Posted | Month 4 | Participants |
| Other Pre-specified | Caregiver's Feeding Styles Questionnaire Score | 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. | Not Posted | month 4 | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Online-Only Video Series | Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward. Video Series: Videos geared toward responsive feeding practices. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Group Sessions | Parents will participate in 2 weekly group sessions with video viewing and group discussion. Video Series: Videos geared toward responsive feeding practices. Group Discussion Sessions: Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |