NCT06259539

Brief Summary

Parents as primary caregivers play an important role in shaping children's mealtime and eating behaviors; and in preventing weight gain. Conventionally, in-person, parent-implemented treatments have worked well for children with autism, however, post-COVID-19 pandemic there is a need for virtual, evidence-based training for parents to improve nutrition in children with autism and weight issues. This study aims to: a) increase self-efficacy among parents of children with autism and overweight or obesity to feed their children a healthy diet, b) improve parental nutrition knowledge and skills on how to feed their child with autism and overweight or obesity a healthier diet, c) improve their child's mealtime behaviors, and d) increase the child's dietary variety.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Keywords

Mixed-methods researchYouTubeNutrition education

Outcome Measures

Primary Outcomes (2)

  • Parental self-efficacy

    The study utilized a previously validated 9-item list questionnaire that measured their level of confidence (self-efficacy) in their ability to make nutrition-related decisions for their child with autism and overweight or obesity

    8 weeks

  • Parents's nutrition knowledge

    To test this, a previously validated 18-item questionnaire was administered to test their knowledge of family mealtimes, food groups, and meal planning.

    8 weeks

Secondary Outcomes (2)

  • Brief Autism Mealtime Behavior Inventory (BAMBI)

    8 weeks

  • Child's food intake

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

This group completed an 8-week virtual, YouTube-delivered nutrition education intervention. They were expected to watch the assigned videos per week at least once and practice the skills and strategies with their child with autism. This group completed all the baseline, mid-point, and end-point data using the questionnaires/surveys on Qualtrics.

Behavioral: YouTube nutrition education

Control

NO INTERVENTION

This group completed all surveys but received no intervention. They received access to all study materials at the end of the study.

Interventions

For those in the intervention group, the YouTube training modules had step-by-step recipe demonstrations, strategies on how to get your child to eat more new foods, social stories, First-Then visual chart, and other nutrition education materials. All the videos were less than 5 minutes long, and parents were assigned 2 videos per week for 8 consecutive weeks. Parents answered 2 open-ended questions each week related to the educational materials they reviewed.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants have a child between the ages of 6 to 11 years with a diagnosis of autism
  • have a child with autism with a Body Mass Index (BMI) equal to or greater than the 85 percentile
  • they can read and understand English
  • they can access the internet and participate in online research
  • their child with autism accepts at least 20 foods
  • their child with autism is not on a special restricted diet
  • their child with autism does not consume any medications affecting eating.
  • they are 18 years of age or older

You may not qualify if:

  • if the child is on medication such as antidepressants, antipsychotics, or SSRIs
  • if the child has high food selectivity (eats less than 20 foods).
  • if the child has a healthy body weight.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Denton, Texas, 76204, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderPediatric Obesity

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Miteshri D Prajapati, M.S

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

September 7, 2023

Primary Completion

February 10, 2024

Study Completion

February 13, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations