- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06259539
A YouTube Curriculum for Children With Autism and Obesity
Effectiveness of a YouTube-delivered Nutrition Education Intervention Among Parents of Children With Obesity and Autism: The Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study sought to recruit 24 parents of children with Autism Spectrum Disorder (ASD), and overweight or obesity via emails, digital flyers, and handouts on social media (Facebook), in the USA. This randomized, controlled trial behavioral intervention was conducted from September 2023 to February 2024 and included a YouTube-delivered, 8-week, virtual, nutrition education intervention for the parents.
Participants were randomly allotted to either the intervention or control group by using the randomization (RAND) function on Microsoft Excel. Participants in the intervention group received access to the 16 YouTube videos, educational handbook, recipe modeling, and other training, while participants in the control group only got access to the questionnaires/surveys.
All 8 video modules focused on increasing parental nutrition knowledge, skills, and perceived confidence in making food and nutrition-related decisions to feed their child and address mealtime problems, which aligns with Bandura's Social Cognitive Theory constructs of self-efficacy and behavioral capabilities.
Participants were asked to complete validated questionnaires at baseline, mid-point, and end: parental self-efficacy; the Nutrition knowledge survey; Brief Autism Mealtime Behavior Inventory (BAMBI), followed by a small qualitative open-ended questionnaire for parental feedback on the overall acceptability and satisfaction of the intervention at the end of 8-weeks. All participants were asked to use the ASA-24 (National Cancer Institute) to complete a 24-hour food recall for their child with autism at baseline and end-point.
Demographic data was collected at baseline for all participants. Participants were selected if a) they were 18 years or older; b)had a child with autism between the ages 6 and 11 years c) child's Body Mass Index was > 85th percentile; d) child accepted at least 20 foods e) child did not take any medicines that affect appetite and weight.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Denton, Texas, United States, 76204
- Texas Woman's University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
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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.
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No Intervention: Control
This group completed all surveys but received no intervention.
They received access to all study materials at the end of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental self-efficacy
Time Frame: 8 weeks
|
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
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8 weeks
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Parents's nutrition knowledge
Time Frame: 8 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Autism Mealtime Behavior Inventory (BAMBI)
Time Frame: 8 weeks
|
This is an 18-item questionnaire designed to evaluate mealtime behaviors in your child with autism.
|
8 weeks
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Child's food intake
Time Frame: 8 weeks
|
The Automated Self-Administered 24-hour (ASA24®) dietary assessment tool was used to collect and analyze the child's dietary intake to monitor any changes pre and post-intervention.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Miteshri D Prajapati, M.S, Texas Woman's University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2023-307
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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