Trial Outcomes & Findings for Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder (NCT NCT03424811)

NCT ID: NCT03424811

Last Updated: 2025-01-03

Results Overview

24-hour dietary recalls to assess fruit and vegetable intake

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: Change from baseline intake of fruits and vegetables at 3 months
• Results posted on: 2025-01-03

Participant Flow

Participant milestones

Measure	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.	Control Group Information provided will mimic what families may receive during a routine well-child visit.
Overall Study STARTED	19	19
Overall Study COMPLETED	10	19
Overall Study NOT COMPLETED	9	0

Reasons for withdrawal

Measure	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.	Control Group Information provided will mimic what families may receive during a routine well-child visit.
Overall Study Lost to Follow-up	9	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention Group n=19 Participants 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.	Control Group n=19 Participants Information provided will mimic what families may receive during a routine well-child visit.	Total n=38 Participants Total of all reporting groups
Age, Continuous	8.9 Years STANDARD_DEVIATION 1.2 • n=5 Participants	8.4 Years STANDARD_DEVIATION 1.4 • n=7 Participants	8.7 Years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Child BMI-for-age-percentile	68.1 percentile STANDARD_DEVIATION 34.2 • n=5 Participants	63.1 percentile STANDARD_DEVIATION 37.2 • n=7 Participants	65.6 percentile STANDARD_DEVIATION 35.4 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline intake of fruits and vegetables at 3 months

24-hour dietary recalls to assess fruit and vegetable intake

Outcome measures

Measure	Intervention Group n=19 Participants 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.	Control Group n=19 Participants Information provided will mimic what families may receive during a routine well-child visit.
3-month Fruit and Vegetable Intake	2.16 Servings per day Standard Error 0.43	3.01 Servings per day Standard Error 0.41

PRIMARY outcome

Timeframe: Change from baseline intake to end of intervention (3 months)

24-hour dietary recalls

Outcome measures

Measure	Intervention Group n=19 Participants 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.	Control Group n=19 Participants Information provided will mimic what families may receive during a routine well-child visit.
3-month Snack Intake	420.8 Calories per day Standard Error 58.4	385.7 Calories per day Standard Error 51.0

PRIMARY outcome

Timeframe: Change from baseline to end of intervention (3 months)

24-hour dietary recalls to assess sugar-sweetened beverage intake.

Outcome measures

Measure	Intervention Group n=19 Participants 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.	Control Group n=19 Participants Information provided will mimic what families may receive during a routine well-child visit.
3-month Sugar-sweetened Beverage Intake	7.6 Fluid ounces per day Standard Error 1.7	7.3 Fluid ounces per day Standard Error 1.6

SECONDARY outcome

Timeframe: 3 months

Population: Feedback from caregivers in the intervention group.

The study aimed to better understand participant experiences with motivation, user-friendliness, ease of use of the mobile health technology.

Outcome measures

Measure	Intervention Group n=10 Participants 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.	Control Group Information provided will mimic what families may receive during a routine well-child visit.
Evaluation of mHealth Intervention - User Evaluation Number of parents who said app was helpful for increasing child's consumption of healthy foods.	4 Participants	—
Evaluation of mHealth Intervention - User Evaluation Number of parents who said app was helpful for decreasing child's consumption of unhealthy foods.	2 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: Feedback from caregivers in the intervention group.

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.

Outcome measures

Measure	Intervention Group n=10 Participants 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.	Control Group Information provided will mimic what families may receive during a routine well-child visit.
Evaluation of mHealth Intervention - Technology Engagement Number of parents who said that they enjoyed using the app somewhat or very much.	7 participants	—
Evaluation of mHealth Intervention - Technology Engagement Number of parents who said that their child enjoyed using the app somewhat or very much.	4 participants	—

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tanja Kral

University of Pennsylvania

Phone: (215) 573-7512

Email: tkral@nursing.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place