Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder
Phase: NA
Conditions: Diet Modification
Sponsor: University of Pennsylvania

Study Protocol and Statistical Analysis Plan 
DATE: October 26, 2021 
PROTOCOL TITLE: Mobile health (mHealth) nutrition intervention for children with Autism Spectrum Disorder 
Clinical Trial Registration: This study was registered at clinicaltrials.gov as NCT03424811 

 
 
OBJECTIVES: 
Primary Aim: 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/beverages in children with ASD who are picky eaters. We 
hypothesized that, by the end of the intervention, children in the intervention group, but not children in the education 
group, would show a significant increase (expressed as % change from baseline) in intake of FV and a decrease in 
calories consumed from salty and sugary snacks and SSB.  
Secondary Aim: To perform a comprehensive evaluation of the mHealth intervention by measuring parent and child 
engagement, motivation, user friendliness, and ease of use.   
 
CHARACTERISTICS OF THE STUDY POPULATION: 
 
1. Target Population and Accrual: 
The study aimed to include 46 racially/ethnically diverse boys/girls with ASD, ages 6-10 years, and their parent/legal 
guardian (referred to ‘parent’ for ease of use). The age range was chosen to ensure that children have the cognitive 
skills to interact with the technology. Our multi-pronged recruitment plan utilized the CHOP health system and 
community-based organizations throughout Philadelphia. The study was open to subjects of all races and 
ethnicities. Parents must be the children’s primary caregiver (i.e., person responsible for grocery shopping/feeding). 
Children and parents must have access to a smartphone or tablet to be eligible for study participation. For this 
exploratory trial, we aimed to recruit a well-defined, homogenous group of children to determine the efficacy of this 
intervention. Only children without significant developmental delay (i.e., IQ ≥80 and comparable verbal ability) were 
enrolled to increase the likelihood of comprehension and engagement with the technology. Children with a range in 
weight were included to explore if the intervention is equally effective in normal-weight and overweight/obese 
children. 
 
This project’s primary purpose was to evaluate feasibility, acceptability, and utilization of the mHealth intervention 
and to obtain preliminary effect size estimates. A power analysis was conducted (PASS software, Version 11, NCSS 
LLC, Kaysville, UT) for Primary Aim 2 using 3-month changes in intake of targeted healthy foods (FV) as the primary 
outcome variable. The estimated mean (±SD) for baseline FV intake (2.57 ± 1.20 servings/day) was derived from 
our pilot study in children with ASD. Based on this estimate, a sample size of 46 children and an attrition rate of 
10%, we had 80% power to detect a statistically significant increase in FV intake of 1.1 servings/day (or 43%) in the 
intervention group relative to the education group at the alpha 0.05 level, based on a two sample t-test. The 
magnitude of this increase is comparable to that achieved in behavioral interventions in TDC and represents ~one-
fifth of the RDA of FV for children of that age.  
 
2. Key Inclusion Criteria: 
To be included in the study, children had to:  
1) Were age 6 to 10 years;  
2) Were fluent in English;  
3) Had an ASD diagnosis using the DSM-IV-TR or DSM-5 criteria,  confirmed using gold standard diagnostic 
criteria (e.g., ADOS or ADI-R administration), or expert clinical judgment;  
4) Had cognitive skills within low average (or higher) range with IQ measurement of ≥80 and comparable verbal 
ability;  
5) Met the definition of picky eater (i.e., parent endorses at least two out of the three items on the Picky Eating 
Subscale of the Child Feeding Questionnaire (CFQ), and have pickiness related to the intervention’s 
targeted healthy and less healthy foods; 
6) Had access to a mobile device. 
 
These criteria were confirmed by expert review of reports of previous research or community-based diagnostic 
evaluations.  
 
 
 
 
3. Key Exclusion Criteria: 
Children were excluded if they: 
1) Had moderate-severe hearing/visual or motor impairment (e.g., non-ambulatory);  
2) Were taking antipsychotic medications related to uncontrolled eating;  

 
 
3) Were on a special diet (e.g., gluten/casein-free diet);  
4) Were underweight (i.e., BMI-for-age < 5th percentile). 
 
4. Subject Recruitment and Screening: 
Families were consecutively recruited for participation in the study over the duration of the study. Recruitment of 
participants was carried out in collaboration with the Children’s Hospital of Philadelphia’s (CHOP) Center for Autism 
Research (CAR; https://www.centerforautismresearch.org/). CAR is one of ten Centers of Emphasis of the 
Research Institute at CHOP and houses >75 faculty and staff. The Research Clinic completes an average of 20 
diagnostic and phenotypic characterizations per week. Our multi-pronged recruitment plan utilized the following 
strategies: (a) CAR’s research study page of its website (https://www.chop.edu/centers-programs/autism-
integrated-care-program/clinical-trials); (b) CAR’s online research registry autismMatch; (c) CAR’s completed 
research; (d) the Autism Treatment Network center; (e) CHOP’s Division of Developmental and Behavioral 
Pediatrics and Department of Child and Adolescent Psychiatry and Behavioral Sciences; (f) the CHOP Recruitment 
Enhancement Core; and (g) community-based organizations. Parents provided information about their child’s age, 
sex, height, weight, autism diagnosis, medical history, and medication use. Research staff administerd the CFQ 
Picky Eating subscale and asked parents to verbally consent to a standard HIPAA Release of Medical Information 
form to have their child’s medical information and previous diagnostic evaluations reviewed.  
 
5. Vulnerable Populations:  
Children with a diagnosis of ASD between ages 6 and 10 years were enrolled in this study with their parents’ 
consent. All children in the study who are capable of assenting were asked to provide voluntary assent.  
 
STUDY DESIGN: 
A 3-month randomized controlled trial tested the efficacy of a mHealth intervention on changing consumption of 
targeted healthy (FV) and less healthy (SSB/SSS) foods/beverages in children with ASD who are picky eaters. In 
this exploratory trial, parent-child dyads were randomly assigned to either an mHealth (+ parent training) 
intervention group or an education group. Parents in the intervention group received the mHealth nutrition 
intervention plus training in behavior change strategies and an explanation of the dietary targets. Parents in the 
education group received a handout with general educational information about healthy eating and an explanation 
of the dietary targets. Parent trainings in both groups were matched for in-person contact time. Families in the 
education group received access to the mHealth intervention after they completed the study.   
At the end of the intervention, parents in the intervention group were asked to complete a semi-structured interview 
and a brief questionnaire, which asked them to provide feedback on the usefulness and relevance of the mHealth 
technology, parent and child engagement and motivation, and to evaluate key features of the mHealth intervention 
such as user friendliness, ease of use, and technical or time barriers. Children in the intervention group were asked 
to complete a brief questionnaire that assessed level of enjoyment, learning, and understanding of the mHealth 
technology.  
 
METHODS: 
 
1. Mobile health (mHealth) Intervention: The mHealth intervention incorporated evidence-based core behavior 
change strategies that have been empirically tested in family-based behavioral modification nutrition and obesity 
prevention programs with TDC for over three decades. A novel feature of the mHealth intervention was that both 
the technology-assisted intervention and the dietary goals were tailored to the specific needs of children with ASD.  
Core Behavior Change Strategies: The core behavior change strategies that were incorporated in the mHealth 
intervention included: 1) specifying target behaviors and goal setting, 2) self-monitoring, 3) stimulus control, 4) 
positive reinforcement, and 5) self-efficacy.  
The mHealth intervention included a ‘Nutrition Ninja’, which represents a graphical illustration in the form of an 
avatar who models consuming healthy and limiting less healthy target foods. The Nutrition Ninja aimed to affect 
behavior change via two components of the mHealth intervention: 1) a parent-child interactive feature and 2) an 
educational nutrition game. In the parent-child interactive feature, the ‘Nutrition Ninja’ was directed by the parent 
and, with input from their child, set dietary goals for a specific period of time (e.g., 1 week). The child was reinforced 
for making healthy food choices while limiting less healthy food choices in their daily lives by earning points towards 
a prize. The dietary goals included consumption of a pre-determined amount of targeted healthy foods (FV) and 
limiting intake of targeted less healthy foods (SSB/SSS). Both the child and the parent were able to track the child’s 

 
 
progress via their smartphones/tablets. Parents provided opportunities for children to taste and eat FV by making 
these foods available in their homes and they limited exposure to SSB/SSS which children needed to refrain from 
eating. Children were reinforced for consuming the healthy target foods and limiting the less healthy target foods 
by earning points towards a prize. Families were able to choose their own rewards. In the app, we provided 
examples of rewards (e.g., movie night, extra TV or computer time, sleepover party with friend, game night).  
The educational nutrition game aimed to educate children about healthy and less healthy food choices. The game 
used a simplified version of the traffic light system to categorize foods and beverages into healthy (green or ‘Go’) 
and unhealthy (red or ‘Whoa’) choices. Children were reinforced for playing the game and for identifying healthy 
and less healthy food choices by earning points towards a prize. The Nutrition Ninja interacted with the child 
throughout the game by praising the child for correct answers, correcting incorrect answers, and modeling healthy 
food choices. Parents selected real-life prizes, awarded points, and determined the allotted timeframe and number 
of points it took for the child to earn a prize.   
Tailoring intervention to children with ASD: Children with ASD have specific needs and this mHealth intervention 
incorporated several features that have been shown in prior treatment studies to help children with ASD meet 
behavioral goals. One, the use of an animated ‘Nutrition Ninja’ for guidance (setting dietary goals) and correction 
(correcting wrong answers during the educational game) not only removed the onus from the parents but it also 
provided children with behavioral skills training in the virtual space. Two, the dietary goals were very prescriptive 
(e.g., amount of SSB allowed per week) to provide children with a highly structured and predictable schedule and 
their progress towards their dietary goals was displayed in a visual graphic. We conducted focus group webinars 
with parents and caregivers (nurse/teacher) of children with ASD during which they confirmed that these strategies 
were crucial for successfully engaging children in the intervention and improving their dietary intake.  
The intervention was developed using an iterative design process for prototype development, testing and refining. 
An Advisory Board consisting of autism clinical experts, nutrition/health behavior scientists, a behavior specialist, 
parents of children with ASD, youth with ASD, and technology developers provided feedback on the functionality 
and acceptability of the intervention during several sessions which corresponded with major project development 
phases.  
 
1. Study Instruments: 
 
Assessment of Intake of Target Foods: Targeted healthy foods included FV (fresh, canned, frozen). Parents 
were instructed to omit energy-dense toppings/sauces on FV. Targeted less healthy foods included 1) SSS (e.g., 
all types of chips, popcorn, pretzels, party mixes, ice cream, candy, cookies, cakes/pies, sweet rolls, pastries) and 
2) SSB (e.g., sugar-sweetened sodas, fruit drinks/punches and fruit juices, sport drinks, and energy drinks). Dietary 
goals were set by parents and tailored to children’s preferences and sensory sensitivities. Children’s intake was 
assessed at baseline and at the end of the intervention using the telephone-based 24-hr dietary recall method; the 
gold standard for self-reported intake. Each assessment consisted of 3 unannounced recalls (2 weekdays, 1 
weekend day), which was conducted by research dietitians from the CHOP Center for Human Phenomic Science. 
Dietitians were blinded to families’ group assignment. During each recall, they asked parents, with help from the 
children, to describe all foods/beverages consumed by their children during the prior 24 hours and provide detailed 
information about portion sizes/preparation methods. Data were analyzed for daily FV intake (servings/day; cup 
equivalents) and calories consumed from SSB/SSS using the University of Minnesota Nutrition Coordinating 
Center’s Food and Nutrient Database. All data were averaged across the 3 days.  
 
Child Height and Weight Measures: At baseline and at the end of the intervention, children had their heights and 
weights measured. Measurements were taken in triplicate with a portable scale/stadiometer by a trained staff 
member in children’s homes with children wearing light clothing (no shoes). Child age- and sex-specific BMI 
percentiles and z-scores were calculated using the CDC Growth Charts 2000. Children were classified as normal-
weight (BMI-for-age 5–84th percentile), overweight (BMI-for-age 85–94th percentile), or obese (BMI-for-age ≥95th 
percentile).  
 
Questionnaires: During the telephone screening, parents were asked to complete the Picky Eating subscale of the 
Child Feeding Questionnaire (CFQ), which consists of the following items: 1) “My child’s diet consists of only a few 
foods”; 2) “My child is unwilling to eat many of these foods that our family eats at mealtimes”; 3) “My child is fussy / 
picky about what she eats.” A child was defined as a picky eater if the parent endorsed at least 2 out of the 3 items. 
Parents were asked follow-up questions to determine whether a child’s pickiness was related to the intervention’s 
targeted healthy and less healthy foods. During the baseline visit, parents completed a Demographic Questionnaire 
and the 38-item Sensory Profile, 2nd Edition (short form), which assessed children’s sensory processing abilities, 
including oral sensory sensitivity (e.g., sensitivities to food tastes/textures). Children were categorized as having 
typical or atypical oral sensory sensitivity based on classifications specified by Dunn.     
 

 
 
Evaluation of mHealth Intervention: We evaluated the mHealth intervention using the following strategies: 1) 
Engagement: The mHealth platform kept an automatic log of all user activities, including subjects’ log-in frequency, 
duration of use, features used, goal/progress tracking, number of points and rewards awarded, etc. These log files 
were automatically generated by the software and enabled us to monitor participants’ compliance with the 
intervention; 2) Semi-structured interviews and brief questionnaires: At the end of the intervention, parents in the 
intervention group were asked to complete a semi-structured interview and a brief questionnaire, which asked them 
to provide feedback on the usefulness and relevance of the mHealth technology, parent and child engagement and 
motivation, and to evaluate key features of the mHealth intervention such as user friendliness, ease of use, and 
technical or time barriers. Children in the intervention group were asked to complete a brief questionnaire that 
assessed level of enjoyment, learning, and understanding of the mHealth technology  
 
2. Group Modifications: 
Parents in the education group were not asked to participate in the evaluation of the mHealth intervention.   
 
3. Method for Assigning Subjects to Groups: 
Statisticians of the Biostatistics Consulting Unit at the Penn School of Nursing carried out the randomization of 
participants into the intervention and education groups. They used a randomized block design to produce groups 
that are comparable in weight status.    
 
4. Administration of Surveys and/or Process:  
 
Telephone Screening: The telephone screening involved review of information to determine initial eligibility criteria. 
In addition, during the screening phone call verbal consent was obtained for completion of the baseline dietary recall 
interviews with the parent prior to the baseline visit.  
 
Baseline Study Visit: The baseline study visits included the full written consenting/assenting process, measurement 
of child height and weight, completion of questionnaires, and, for families in the intervention group, orientation to 
the technology and installation of the software on participants’ smartphones. This visit lasted approximately 90 
minutes.  
 
3-Month Study Visit: The 3-month study visit (end of intervention) included measurement of child height and weight 
and, for families in the intervention group, a semi-structured interview and two brief questionnaires to evaluate the 
mHealth intervention. This visit lasted approximately 60 minutes.  
 
Dietary Recalls: Children’s intake was assessed at baseline and at the end of the intervention using the telephone-
based 24-hr dietary recall method. Each assessment consisted of 3 unannounced recalls (2 weekdays, 1 weekend 
day), which were conducted by research dietitians from the CHOP Center for Human Phenomic Science. Each 
recall lasted approximately 20 minutes.  
 
 
STUDY PROCEDURES: 
 
Randomized Controlled Trial: 
Intervention Group: At baseline, parents in the intervention group received a comprehensive parent training which 
1) provided skills training in the five core behavior change strategies and 2) explained the nutritional goals and 
targeted foods/beverages for the study. The training modules were designed by a behavioral strategist and clinical 
psychologist, a clinical psychologist, and a nutrition scientist. The modules reviewed examples of the targeted 
foods/beverages and provided training in how to present feeding opportunities, incorporate healthy target foods in 
daily family meals and snacks, and substitute the less healthy target foods/beverages for healthier options. The 
training also addressed how parents can overcome resistance in children trying new foods using differential 
attention and positive reinforcement techniques. It included instructions on how to use the mHealth technology and 
showed parents how to set dietary goals, select real-life prizes, award points, and determine the allotted timeframe 
and number of points it will take for the child to earn a prize. The mHealth intervention was personalized for each 
child to take into account individual differences in children’s food preferences, level of picky eating, sensory 
sensitivities, etc. Specifically, the mHealth technology enabled parents to tailor the selection of food choices 
available to the child and customize, with input from the child, food preparation methods (e.g., raw or cooked, 
seasonings to be added). The training also included a training module for the children to show them how to navigate 
the technology, orient them to the nutrition intervention, and explained the reward system. Research staff assisted 
with the software installation on the families’ electronic devices and parents were encouraged to use the technology 
as frequently as possible during meal and snacks times over the course of the 3-month intervention.   

 
 
Education Group: Parents in the education group were instructed to review a handout, which provided general 
educational information about healthy eating. It explained the nutritional goals and targeted foods/beverages for the 
study, but it did not provide parent skills training in the core behavioral strategies. This condition mimiced what 
families may receive during a routine well-child visit.  
Parents in both groups were encouraged to promote children’s intake of the healthy target foods and limit their 
intake of the less healthy target foods/beverages on a daily basis for the next 3 months.  
 
5. Statistical Analysis: 
To test Primary Aim 2, a mixed-effects linear model with repeated measures assessed 3-month changes in 
children’s FV (cups/day) and SSB/SSS (calories/day) intake by group. The fixed factor effects in all models were 
group (incentive, control) and time (baseline, month 3). The group-by-time interaction was tested and removed if 
not significant. Analysis of covariance assessed if the intervention is equally successful in boys/girls, children of 
various ages/weights, and children with typical/atypical sensory sensitivity. For Secondary Aim 2, data from log files 
and questionnaires were analyzed and open-ended responses from the semi-structured interview were coded, 
compiled into categories, and grouped into themes using a general inductive approach. P values were two-sided 
and P<0.05 was considered significant for all tests. First, analyses were conducted with all participants included. 
Then, a sensitivity analysis were conducted that included only participants who actively participated in the 
intervention.