Diet Modification
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Mobile health intervention to promote healthy eating.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 6 to 10 years; * fluent in English; * have an ASD diagnosis; * cognitive skills within average (or higher) range with IQ ≥ 80; * above or standardized receptive language scores.
Exclusion criteria
* moderate-severe hearing/visual or motor impairment; * taking antipsychotic medications; * on special diet; * are underweight (BMI-for-age \< 5th percentile).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month Fruit and Vegetable Intake | Change from baseline intake of fruits and vegetables at 3 months | 24-hour dietary recalls to assess fruit and vegetable intake |
| 3-month Snack Intake | Change from baseline intake to end of intervention (3 months) | 24-hour dietary recalls |
| 3-month Sugar-sweetened Beverage Intake | Change from baseline to end of intervention (3 months) | 24-hour dietary recalls to assess sugar-sweetened beverage intake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of mHealth Intervention - User Evaluation | 3 months | The study aimed to better understand participant experiences with motivation, user-friendliness, ease of use of the mobile health technology. |
| Evaluation of mHealth Intervention - Technology Engagement | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Control Group Information provided will mimic what families may receive during a routine well-child visit. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 0 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 8.9 Years STANDARD_DEVIATION 1.2 | 8.4 Years STANDARD_DEVIATION 1.4 | 8.7 Years STANDARD_DEVIATION 1.3 |
| Child BMI-for-age-percentile | 68.1 percentile STANDARD_DEVIATION 34.2 | 63.1 percentile STANDARD_DEVIATION 37.2 | 65.6 percentile STANDARD_DEVIATION 35.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 17 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | 3-month Fruit and Vegetable Intake | 2.16 Servings per day | Standard Error 0.43 |
| Control Group | 3-month Fruit and Vegetable Intake | 3.01 Servings per day | Standard Error 0.41 |
Primary
3-month Snack Intake
24-hour dietary recalls
Time frame: Change from baseline intake to end of intervention (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | 3-month Snack Intake | 420.8 Calories per day | Standard Error 58.4 |
| Control Group | 3-month Snack Intake | 385.7 Calories per day | Standard Error 51 |
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | 3-month Sugar-sweetened Beverage Intake | 7.6 Fluid ounces per day | Standard Error 1.7 |
| Control Group | 3-month Sugar-sweetened Beverage Intake | 7.3 Fluid ounces per day | Standard Error 1.6 |
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.
Time frame: 3 months
Population: Feedback from caregivers in the intervention group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Evaluation of mHealth Intervention - Technology Engagement | Number of parents who said that they enjoyed using the app somewhat or very much. | 7 participants |
| Intervention Group | Evaluation of mHealth Intervention - Technology Engagement | Number of parents who said that their child enjoyed using the app somewhat or very much. | 4 participants |
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.
Time frame: 3 months
Population: Feedback from caregivers in the intervention group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Evaluation of mHealth Intervention - User Evaluation | Number of parents who said app was helpful for increasing child's consumption of healthy foods. | 4 Participants |
| Intervention Group | Evaluation of mHealth Intervention - User Evaluation | Number of parents who said app was helpful for decreasing child's consumption of unhealthy foods. | 2 Participants |