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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05994924
Other study ID # IRB00078071
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 6, 2024
Est. completion date June 2024

Study information

Verified date June 2023
Source Wake Forest University Health Sciences
Contact Callie Brown, MD, MPH
Phone 336-716-4987
Email calbrown@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Handout
Educational handout describing responsive feeding practices.
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.

Locations

Country Name City State
United States Atrium Health Wake Forest Baptist Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary Number of Parents Approached Number of parents who are approached for participation at 3 primary care offices. Baseline
Primary Number of Parents Consented Number of parents that consented to participating in the study. Baseline
Primary Number of Parents who Viewed Videos Provided by Provider tracking the number of videos viewed by each parent Month 2
Primary Number of Parents who Complete In-Person Group Sessions tracking the number of sessions attended by each parent Month 2
Primary 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
Primary 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
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 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. 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. 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. 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. 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. 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. 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. Month 4
Secondary 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
Secondary 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
Secondary 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
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 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". 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. month 4
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