Clinical trial NCT05994924: Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
Official title: A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Number of Parents Approached
timeFrame: Baseline
measure: Number of Parents Consented
timeFrame: Baseline
measure: Number of Parents who Viewed Videos Provided by Provider
timeFrame: Month 2
measure: Number of Parents who Complete In-Person Group Sessions
timeFrame: Month 2
measure: Parent Acceptance of Intervention - Percent of parents
timeFrame: Month 4
measure: Provider Acceptance of Intervention - Percent of providers
timeFrame: Month 4
measure: Facilitator Acceptance of Intervention - Percent of facilitators
timeFrame: Month 4
Secondary outcomes:
measure: Mean pressure to eat score (Child Feeding Questionnaire)
timeFrame: Month 4
measure: Mean restriction score (Child Feeding Questionnaire)
timeFrame: Month 4
measure: Mean satiety responsiveness score
timeFrame: Month 4
measure: Mean food responsiveness score
timeFrame: Month 4
measure: Mean enjoyment of food score
timeFrame: Month 4
measure: Mean of families using structured mealtime practices
timeFrame: Month 4
measure: Percentage of families eating family meals at least 3 times per week
timeFrame: Month 4
measure: Percentage of Parents that are categorized into four feeding styles (Caregiver's Feeding Styles Questionnaire Reduced Version)
timeFrame: month 4
measure: Fidelity of intervention delivery - Percentage of key points
timeFrame: month 4
measure: Facilitator Self-Competence Percentage - Percentage of facilitators
timeFrame: month 4
measure: Fidelity of Receipt - : Percentage of parents
timeFrame: month 4
measure: Percentage of Parents who Identified a Goal
timeFrame: month 4
measure: Enactment percentage
timeFrame: month 4
Other outcomes:
measure: Qualitative Analysis
timeFrame: month 4
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Callie Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: