Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06259539 |
| Other study ID # |
IRB-FY2023-307 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 7, 2023 |
| Est. completion date |
February 13, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Texas Woman's University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
