Autism Spectrum DisorderNCT06259539
A YouTube Curriculum for Children With Autism and Obesity
A study testing YouTube nutrition education in people with Autism Spectrum Disorder and Obesity, Childhood, run by Texas Woman's University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Obesity, Childhood
- What is being tested?
- YouTube nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a YouTube-delivered Nutrition Education Intervention Among Parents of Children With Obesity and Autism: The Intervention Study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Obesity, Childhood
- Being tested
- YouTube nutrition education
- Keywords
- Mixed-methods research, YouTube, Nutrition education
- Medical subject headings
- Autism Spectrum Disorder, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouTube nutrition educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
Brief Autism Mealtime Behavior Inventory (BAMBI)
This is an 18-item questionnaire designed to evaluate mealtime behaviors in your child with autism.
Measured: 8 weeks
Child's food intake
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start7 Sep 2023
- Primary completion10 Feb 2024 (estimated)
- Study completion13 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Woodcock Institute for the Advancement of Neurocognitive Research and Applied Practice
- Responsible party
- Sponsor
- Investigators
- Miteshri D Prajapati, M.S, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259539
- Sponsor's protocol ID
- IRB-FY2023-307
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a YouTube-delivered Nutrition Education Intervention Among Parents of Children With Obesity and Autism: The Intervention Study
- ClinicalTrials.gov ID
- NCT06259539
- Acronym / sponsor ID
- IRB-FY2023-307
- Conditions
- Autism Spectrum Disorder, Obesity, Childhood
- Keywords
- Mixed-methods research, YouTube, Nutrition education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Woodcock Institute for the Advancement of Neurocognitive Research and Applied Practice
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 13 Feb 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: YouTube nutrition educationThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YouTube nutrition educationFor 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. | Behavioural | Intervention |
Primary outcome
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
Parents's nutrition knowledge
Time frame: 8 weeks
To test this, a previously validated 18-item questionnaire was administered to test their knowledge of family mealtimes, food groups, and meal planning.
2 secondary outcomes
Brief Autism Mealtime Behavior Inventory (BAMBI)
Time frame: 8 weeks
Child's food intake
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miteshri D Prajapati, M.S principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YouTube nutrition education in people with Autism Spectrum Disorder and Obesity, Childhood, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental self-efficacy (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.