Trial Outcomes & Findings for Improving Nutritional Choices in Adolescents (NCT NCT03693144)
NCT ID: NCT03693144
Last Updated: 2022-11-14
Results Overview
Change in number of weekly visits to Fast Food Restaurants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Over 6 months
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Intervention Group 1 Full LIITA3H App
Participants were given the LIITA3H app, which is a combination product consisting of 3 main features that: tracks their visits to fast food restaurants (using the ELI feature), sends tailored text messages to prompt healthy choices when they are in a fast food restaurant (using the POP feature), and allows them to submit pictures of their food (using the SNAP feature).
Full LIITA3H App: This is the full version of the LIITA3H mobile app that used the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and allows participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.
|
Control Group 2 Partial LIITA3H App
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) and they could submit pictures of their food (using the SNAP feature). However, they did not receive tailored text messages.
Partial LIITA3H App: This is a version of the LIITA3H mobile app that tracks participants' location and allows them to submit photos of their food.
|
Control Group 3 LIITA3H Location Only
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food.
LIITA3H Location only: This is a version of the LIITA3H mobile app that only tracks participants' location.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Nutritional Choices in Adolescents
Baseline characteristics by cohort
| Measure |
Intervention Group 1 Full LIITA3H App
n=7 Participants
Participants were given the LIITA3H app, which is a combination product consisting of 3 main features that: tracks their visits to fast food restaurants (using the ELI feature), sends tailored text messages to prompt healthy choices when they are in a fast food restaurant (using the POP feature), and allows them to submit pictures of their food (using the SNAP feature).
Full LIITA3H App: This is the full version of the LIITA3H mobile app that used the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and allows participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.
|
Control Group 2 Partial LIITA3H App
n=7 Participants
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) and they could submit pictures of their food (using the SNAP feature). However, they did not receive tailored text messages.
Partial LIITA3H App: This is a version of the LIITA3H mobile app that tracks participants' location and allows them to submit photos of their food.
|
Control Group 3 LIITA3H Location Only
n=5 Participants
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food.
LIITA3H Location only: This is a version of the LIITA3H mobile app that only tracks participants' location.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15 years
n=5 Participants
|
14 years
n=7 Participants
|
15 years
n=5 Participants
|
15 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Over 6 monthsPopulation: Due to COVID changes forcing closure of Fast Food Restaurants and changes in restaurant indoor dining policies; along with changes in behavior associated with COVID-related lockdowns, no six month data for this outcome was acquired.
Change in number of weekly visits to Fast Food Restaurants
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After 6 months of app usePopulation: Due to COVID changes forcing closure of Fast Food Restaurants and changes in restaurant indoor dining policies; along with changes in behavior associated with COVID-related lockdowns, no six month data for this outcome could be acquired.
Change in number of calories purchased per week at Fast Food Restaurants
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Over 6 monthsPopulation: This was not analyzable due to problems with the technology employed. During the COVID truncated implementation of this trial, the means to allow participants to confirm or deny that they were in a Fast Food Restaurant when the app signaled that they were was not incorporated into the app appropriately. Comparably, the ability for them to tell us that they were in a Fast Food Restaurant but that the app failed to identify that location as a FFR was not incorporated into the app appropriately.
Percentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: over 1 monthPopulation: The population consisted of participants in the intervention arm
Percentage of times the app delivers a tailored message for a menu item at the Fast Food Restaurant in which the participant is located. (number of times a tailored message is delivered divided by the number of times the app identified that the user was in a Fast Food Restaurant x 100).
Outcome measures
| Measure |
Intervention Group 1 Full LIITA3H App
n=7 Participants
Participants were given the LIITA3H app, which is a combination product consisting of 3 main features that: tracks their visits to fast food restaurants (using the ELI feature), sends tailored text messages to prompt healthy choices when they are in a fast food restaurant (using the POP feature), and allows them to submit pictures of their food (using the SNAP feature).
Full LIITA3H App: This is the full version of the LIITA3H mobile app that used the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and allows participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.
|
Control Group 2 Partial LIITA3H App
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) and they could submit pictures of their food (using the SNAP feature). However, they did not receive tailored text messages.
Partial LIITA3H App: This is a version of the LIITA3H mobile app that tracks participants' location and allows them to submit photos of their food.
|
Control Group 3 LIITA3H Location Only
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food.
LIITA3H Location only: This is a version of the LIITA3H mobile app that only tracks participants' location.
|
|---|---|---|---|
|
Percentage of Times App Delivers Appropriate Tailored Message
|
100 percentage of times
|
—
|
—
|
SECONDARY outcome
Timeframe: At the completion of at least 1 month in the studyPopulation: Participants who completed the study final assessment interview.
Participants' perception of the acceptability of the app's content and design via qualitative assessment. While the original intent for this outcome measure was to assess perceptions after 6 months of app use, because of the constraints of COVID, these interviews were primarily performed after a single month in the study.
Outcome measures
| Measure |
Intervention Group 1 Full LIITA3H App
n=5 Participants
Participants were given the LIITA3H app, which is a combination product consisting of 3 main features that: tracks their visits to fast food restaurants (using the ELI feature), sends tailored text messages to prompt healthy choices when they are in a fast food restaurant (using the POP feature), and allows them to submit pictures of their food (using the SNAP feature).
Full LIITA3H App: This is the full version of the LIITA3H mobile app that used the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and allows participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.
|
Control Group 2 Partial LIITA3H App
n=3 Participants
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) and they could submit pictures of their food (using the SNAP feature). However, they did not receive tailored text messages.
Partial LIITA3H App: This is a version of the LIITA3H mobile app that tracks participants' location and allows them to submit photos of their food.
|
Control Group 3 LIITA3H Location Only
n=2 Participants
Participants were given the LIITA3H app that tracks their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food.
LIITA3H Location only: This is a version of the LIITA3H mobile app that only tracks participants' location.
|
|---|---|---|---|
|
Participants' Perception of the Experience of Using the App
Possible Desire to Continue App Use
|
4 Participants
|
NA Participants
Control Groups did not receive messages, thus they were not asked this question.
|
NA Participants
Control Groups did not receive messages, thus they were not asked this question.
|
|
Participants' Perception of the Experience of Using the App
Experienced at Least One Difficulty with App Functioning
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Participants' Perception of the Experience of Using the App
Enjoyed Messages
|
4 Participants
|
NA Participants
Control Groups did not receive messages, thus they were not asked this question.
|
NA Participants
Control Groups did not receive messages, thus they were not asked this question.
|
Adverse Events
Intervention Group 1 Full LIITA3H App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group 2 Partial LIITA3H App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group 3 LIITA3H Location Only
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place