An interventional study of Mobile Health Intervention in Diet Modification, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
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Exclusion Criteria:
Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors.
Device: Mobile Health Intervention
Information provided will mimic what families may receive during a routine well-child visit.
Mobile health intervention to promote healthy eating.
3-month Fruit and Vegetable Intake
24-hour dietary recalls to assess fruit and vegetable intake
Time frame: Change from baseline intake of fruits and vegetables at 3 months
3-month Snack Intake
24-hour dietary recalls
Time frame: 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.
Time frame: Change from baseline to end of intervention (3 months)
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.
Time frame: 3 months
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.
Time frame: 3 months
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 19 | 19 |
| Completed | 10 | 19 |
| Not completed | 9 | 0 |
| Withdrew: Lost to follow-up | 9 | 0 |
24-hour dietary recalls to assess fruit and vegetable intake
| Servings per day | Intervention Group | Control Group |
|---|---|---|
| 3-month Fruit and Vegetable Intake | 2.16 ± 0.43 | 3.01 ± 0.41 |
24-hour dietary recalls
| Calories per day | Intervention Group | Control Group |
|---|---|---|
| 3-month Snack Intake | 420.8 ± 58.4 | 385.7 ± 51.0 |
24-hour dietary recalls to assess sugar-sweetened beverage intake.
| Fluid ounces per day | Intervention Group | Control Group |
|---|---|---|
| 3-month Sugar-sweetened Beverage Intake | 7.6 ± 1.7 | 7.3 ± 1.6 |
The study aimed to better understand participant experiences with motivation, user-friendliness, ease of use of the mobile health technology.
| Participants | Intervention Group |
|---|---|
| Number of parents who said app was helpful for increasing child's consumption of healthy foods. | 4 |
| Number of parents who said app was helpful for decreasing child's consumption of unhealthy foods. | 2 |
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.
| participants | Intervention Group |
|---|---|
| Number of parents who said that they enjoyed using the app somewhat or very much. | 7 |
| Number of parents who said that their child enjoyed using the app somewhat or very much. | 4 |
Collected over Adverse event data were collected over the entire 3-month intervention period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Control Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(Years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 8.9 ± 1.2 | 8.4 ± 1.4 | 8.7 ± 1.3 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 18 | 18 | 36 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 12 | 17 | 29 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 5 |
| White | 11 | 15 | 26 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Child BMI-for-age-percentile(percentile) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 68.1 ± 34.2 | 63.1 ± 37.2 | 65.6 ± 35.4 |
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