Diet ModificationNCT03424811

Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder

A study testing Mobile Health Intervention in people with Diet Modification, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 10 years
Conditions the study is for: Diet Modification
What is being tested?: Mobile Health Intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 10 Dec 2018to 31 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

moderate-severe hearing/visual or motor impairment;
taking antipsychotic medications;
on special diet;
are underweight (BMI-for-age < 5th percentile).

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Conditions: Diet Modification
Being tested: Mobile Health Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile Health InterventionDevice
Mobile health intervention to promote healthy eating.

Study groups in NCT03424811
Study group	Role	What they receive
Intervention Group	Experimental	Includes core behavior change strategies and behavioral skills training designed to promote healthy eating behaviors. Receives: Device: Mobile Health Intervention
Control Group	No intervention	Information provided will mimic what families may receive during a routine well-child visit.

What is being measured

The primary outcome is the main question the study is designed to answer.

3-month Fruit and Vegetable Intake
24-hour dietary recalls to assess fruit and vegetable intake
Measured: Change from baseline intake of fruits and vegetables at 3 months
3-month Snack Intake
24-hour dietary recalls
Measured: 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.
Measured: Change from baseline to end of intervention (3 months)

Secondary outcomes (2)

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.
Measured: 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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201831 Aug 2020

First posted7 Feb 2018
Study start10 Dec 2018
Primary completion31 Aug 2020
Study completion31 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diet ModificationStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03424811
Sponsor's protocol ID: 827786
Status last verified: Nov 2024
First submitted: 10 Jan 2018
Last updated: 3 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 39248190
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.
PubMed 36873654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT03424811
Acronym / sponsor ID: 827786
Conditions: Diet Modification
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 10 Dec 2018 (actual)
Primary completion: 31 Aug 2020 (actual)
Study completion: 31 Aug 2020 (actual)
First posted: 7 Feb 2018 (actual)
Results: Posted 3 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention Group	Experimental	Device: Mobile Health InterventionIncludes 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.

Who may qualify

Ages: 6 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

moderate-severe hearing/visual or motor impairment;
taking antipsychotic medications;
on special diet;
are underweight (BMI-for-age < 5th percentile).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile Health InterventionMobile health intervention to promote healthy eating.	Device	Intervention Group

Primary outcome

3-month Fruit and Vegetable Intake
Time frame: 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
Time frame: Change from baseline intake to end of intervention (3 months)
24-hour dietary recalls
3-month Sugar-sweetened Beverage Intake
Time frame: Change from baseline to end of intervention (3 months)
24-hour dietary recalls to assess sugar-sweetened beverage intake.

2 secondary outcomes

Evaluation of mHealth Intervention - User Evaluation
Time frame: 3 months
Evaluation of mHealth Intervention - Technology Engagement
Time frame: 3 months

Results and safety

Results posted to the registry on 3 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	19	10
Control Group	19	19

Primary outcome: 3-month Fruit and Vegetable Intake

Time frame: Change from baseline intake of fruits and vegetables at 3 months. Mean (Standard Error). Unit: Servings per day

Measure	Intervention Group n = 19	Control Group n = 19
Value	2.16 (0.43)	3.01 (0.41)

Primary outcome: 3-month Snack Intake

Time frame: Change from baseline intake to end of intervention (3 months). Mean (Standard Error). Unit: Calories per day

Measure	Intervention Group n = 19	Control Group n = 19
Value	420.8 (58.4)	385.7 (51.0)

Primary outcome: 3-month Sugar-sweetened Beverage Intake

Time frame: Change from baseline to end of intervention (3 months). Mean (Standard Error). Unit: Fluid ounces per day

Measure	Intervention Group n = 19	Control Group n = 19
Value	7.6 (1.7)	7.3 (1.6)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the entire 3-month intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Control Group	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): The coronavirus pandemic significantly interfered with the conduct of the study. All home visits had to be stopped in March of 2020.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39248190Slater 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.
Derived from this study: PubMed 36873654Kral 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.

Related trials for Diet Modification

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily Kuschner, Ph.D. principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Health Intervention in people with Diet Modification, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-month Fruit and Vegetable Intake (time frame: Change from baseline intake of fruits and vegetables at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424811, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.