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

NCT05994924 | Completed

• 1 other identifier: IRB00078071
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

  tracking the number of sessions attended by each parent

  Month 2

• 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

• 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

• 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 Outcomes (13)

• Mean pressure to eat score (Child Feeding Questionnaire)

  Month 4

• Mean restriction score (Child Feeding Questionnaire)

  Month 4

• Mean satiety responsiveness score

  Month 4

• Mean food responsiveness score

  Month 4

• Mean enjoyment of food score

  Month 4

Other Outcomes (1)

• Qualitative Analysis

  month 4

Study Arms (3)

Handout Only

ACTIVE COMPARATOR

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

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.

Behavioral: Video Series

Group Sessions

ACTIVE COMPARATOR

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

Behavioral: Video Series; Behavioral: Group Discussion Sessions

Interventions

Educational Handout BEHAVIORAL

Educational handout describing responsive feeding practices.

Handout Only

Video Series BEHAVIORAL

Videos geared toward responsive feeding practices.

Group Sessions; Online-Only Video Series

Group Discussion Sessions BEHAVIORAL

Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.

Group Sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Callie Brown, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: February 6, 2024
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: March 14, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)