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The high prevalence of mealtime difficulties and obesity among children with autism spectrum disorder (ASD) calls for new and innovative ways to promote healthy eating and weight development in this population. This project aims to develop and test an interactive mobile health (mHealth) nutrition intervention, which incorporates core behavior change strategies that have been empirically tested in family-based nutrition research and behavioral interventions with children with ASD. The feasibility and efficacy of this mHealth intervention to improve dietary outcomes in children with ASD will be tested in a proof-of-concept randomized controlled trial.
Autism spectrum disorder (ASD) is the fastest growing developmental disability affecting more than 2 million US children and tens of millions worldwide. Children with ASD are 5 times more likely to have mealtime challenges and be picky eaters, which in part has been attributed to restrictive and ritualistic behaviors and heightened sensory sensitivity. These nutritional difficulties pose significant every day challenges for caregivers when it comes to child feeding and daily eating routines and call for new and innovative ways to promote healthy eating in children affected by ASD. The use of mobile technologies is rapidly increasing in children across all age groups. Children with ASD, in particular, often engage with mobile devices on a daily basis and mobile health (mHealth) technology has been shown to be an effective tool for improving behavioral, social, and communication skills in children with ASD. The investigators aim to harness the lure of technology and develop and test, for the first time, the feasibility and acceptability of an interactive mHealth nutrition intervention for children with ASD. This intervention will build upon core behavior change strategies that have been empirically tested in family-based nutrition research for over 3 decades. A second aim of this project is to test, in a 3-month randomized controlled trial, the efficacy of the mHealth intervention on changing consumption of targeted healthy and less healthy foods and beverages in 6- to 10-year-old children with ASD who are picky eaters. Primary outcomes of this proof-of-concept trial will include 3-month changes in children's daily intake of fruits and vegetables, salty and sugary snacks, and sugar-sweetened beverages. Secondary outcomes will include parent and child engagement with the mHealth technology, motivation, user friendliness and ease of use. If successful, the use of this innovative mHealth nutrition intervention will offer new and powerful targets for intervention in improving dietary intake and the fight against childhood obesity in this especially vulnerable population of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors. |
|
| Control Group | No Intervention | Information provided will mimic what families may receive during a routine well-child visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health Intervention | Device | Mobile health intervention to promote healthy eating. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-month Fruit and Vegetable Intake | 24-hour dietary recalls to assess fruit and vegetable intake | Change from baseline intake of fruits and vegetables at 3 months |
| 3-month Snack Intake | 24-hour dietary recalls | Change from baseline intake to end of intervention (3 months) |
| 3-month Sugar-sweetened Beverage Intake | 24-hour dietary recalls to assess sugar-sweetened beverage intake. | Change from baseline to end of intervention (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of mHealth Intervention - User Evaluation | The study aimed to better understand participant experiences with motivation, user-friendliness, ease of use of the mobile health technology. | 3 months |
| Evaluation of mHealth Intervention - Technology Engagement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Kuschner, Ph.D. | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Weight and Eating Disorders | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39248190 | Derived | Slater CN, Schroeder K, Fultz A, Kuschner ES, O'Malley L, Johnson K, Benvenuti T, Chittams J, Quinn RJ, Graham Thomas J, Pinto-Martin J, Levy SE, Kral TVE. Insights from user experience and evaluation of a mobile health nutrition intervention for children with autism: A qualitative study. J Hum Nutr Diet. 2024 Dec;37(6):1439-1453. doi: 10.1111/jhn.13365. Epub 2024 Sep 9. | |
| 36873654 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors. Mobile Health Intervention: Mobile health intervention to promote healthy eating. |
| FG001 | Control Group | Information provided will mimic what families may receive during a routine well-child visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors. Mobile Health Intervention: Mobile health intervention to promote healthy eating. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 3-month Fruit and Vegetable Intake | 24-hour dietary recalls to assess fruit and vegetable intake | Posted | Mean | Standard Error | Servings per day | Change from baseline intake of fruits and vegetables at 3 months |
|
Adverse event data were collected over the entire 3-month intervention period.
Adverse event collection followed the definition from clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors. Mobile Health Intervention: Mobile health intervention to promote healthy eating. |
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The coronavirus pandemic significantly interfered with the conduct of the study. All home visits had to be stopped in March of 2020.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanja Kral | University of Pennsylvania | (215) 573-7512 | tkral@nursing.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2021 | Apr 2, 2024 | Prot_SAP_000.pdf |
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Parents in the intervention group will be asked to complete a semi-structured interview, which will ask them about parent and child engagement with the technology. |
| 3 months |
| Derived |
| Kral TVE, O'Malley L, Johnson K, Benvenuti T, Chittams J, Quinn RJ, Thomas JG, Pinto-Martin JA, Levy SE, Kuschner ES. Effects of a mobile health nutrition intervention on dietary intake in children who have autism spectrum disorder. Front Pediatr. 2023 Feb 15;11:1100436. doi: 10.3389/fped.2023.1100436. eCollection 2023. |
Information provided will mimic what families may receive during a routine well-child visit. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Child BMI-for-age-percentile | Mean | Standard Deviation | percentile |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | 3-month Snack Intake | 24-hour dietary recalls | Posted | Mean | Standard Error | Calories per day | Change from baseline intake to end of intervention (3 months) |
|
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| Primary | 3-month Sugar-sweetened Beverage Intake | 24-hour dietary recalls to assess sugar-sweetened beverage intake. | Posted | Mean | Standard Error | Fluid ounces per day | Change from baseline to end of intervention (3 months) |
|
|
|
| Secondary | Evaluation of mHealth Intervention - User Evaluation | The study aimed to better understand participant experiences with motivation, user-friendliness, ease of use of the mobile health technology. | Feedback from caregivers in the intervention group. | Posted | Number | Participants | 3 months |
|
|
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| Secondary | Evaluation of mHealth Intervention - Technology Engagement | Parents in the intervention group will be asked to complete a semi-structured interview, which will ask them about parent and child engagement with the technology. | Feedback from caregivers in the intervention group. | Posted | Number | participants | 3 months |
|
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control Group | Information provided will mimic what families may receive during a routine well-child visit. | 0 | 19 | 0 | 19 | 0 | 19 |
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