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

Primary Purpose

Obesity, Childhood

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Handout
Video Series
Group Discussion Sessions
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring obesity, young children, feeding practices, obesity prevention, obesity intervention, child feeding questionnaire, satiety responsiveness, food responsiveness, family meal frequency questionnaire, structure of family meals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atrium Health Wake Forest Baptist

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Handout Only

Online-Only Video Series

Group Sessions

Arm Description

Parents in this group receive an educational handout at the baseline visit.

Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward.

Parents will participate in 2 weekly group sessions with video viewing and group discussion.

Outcomes

Primary Outcome Measures

Number of Parents Approached
Number of parents who are approached for participation at 3 primary care offices.
Number of Parents Consented
Number of parents that consented to participating in the study.
Number of Parents who Viewed Videos Provided by Provider
tracking the number of videos viewed by each parent
Number of Parents who Complete In-Person Group Sessions
tracking the number of sessions attended by each parent
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
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
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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
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
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
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".
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.

Full Information

First Posted
August 9, 2023
Last Updated
September 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05994924
Brief Title
Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
Acronym
STORY
Official Title
A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Handout Only
Arm Type
Active Comparator
Arm Description
Parents in this group receive an educational handout at the baseline visit.
Arm Title
Online-Only Video Series
Arm Type
Active Comparator
Arm Description
Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward.
Arm Title
Group Sessions
Arm Type
Active Comparator
Arm Description
Parents will participate in 2 weekly group sessions with video viewing and group discussion.
Intervention Type
Behavioral
Intervention Name(s)
Educational Handout
Intervention Description
Educational handout describing responsive feeding practices.
Intervention Type
Behavioral
Intervention Name(s)
Video Series
Intervention Description
Videos geared toward responsive feeding practices.
Intervention Type
Behavioral
Intervention Name(s)
Group Discussion Sessions
Intervention Description
Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.
Primary Outcome Measure Information:
Title
Number of Parents Approached
Description
Number of parents who are approached for participation at 3 primary care offices.
Time Frame
Baseline
Title
Number of Parents Consented
Description
Number of parents that consented to participating in the study.
Time Frame
Baseline
Title
Number of Parents who Viewed Videos Provided by Provider
Description
tracking the number of videos viewed by each parent
Time Frame
Month 2
Title
Number of Parents who Complete In-Person Group Sessions
Description
tracking the number of sessions attended by each parent
Time Frame
Month 2
Title
Parent Acceptance of Intervention - Percent of parents
Description
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
Time Frame
Month 4
Title
Provider Acceptance of Intervention - Percent of providers
Description
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
Title
Facilitator Acceptance of Intervention - Percent of facilitators
Description
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
Secondary Outcome Measure Information:
Title
Mean pressure to eat score (Child Feeding Questionnaire)
Description
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
Title
Mean restriction score (Child Feeding Questionnaire)
Description
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
Title
Mean satiety responsiveness score
Description
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
Title
Mean food responsiveness score
Description
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
Title
Mean enjoyment of food score
Description
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
Title
Mean of families using structured mealtime practices
Description
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
Title
Percentage of families eating family meals at least 3 times per week
Description
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
Title
Fidelity of intervention delivery - Percentage of key points
Description
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
Time Frame
month 4
Title
Facilitator Self-Competence Percentage - Percentage of facilitators
Description
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
Time Frame
month 4
Title
Fidelity of Receipt - : Percentage of parents
Description
Percentage of parents who respond agree or strongly agree to survey question about whether the video content was relevant
Time Frame
month 4
Title
Percentage of Parents who Identified a Goal
Description
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
Title
Enactment percentage
Description
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
Other Pre-specified Outcome Measures:
Title
Qualitative Analysis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Callie Brown, MD, MPH
Phone
336-716-4987
Email
calbrown@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Callie Brown, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Callie Brown, MD, MPH
Phone
336-716-4987
Email
calbrown@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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