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Improving Nutritional Choices in Adolescents

Location Initiated Individualized Texts for African American Adolescent Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03693144
Acronym
LIITA3H
Enrollment
19
Registered
2018-10-02
Start date
2019-11-25
Completion date
2021-05-01
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Brief summary

The goal of this project is to test whether the mobile application helps Black adolescents make healthy food choices at the point of purchase.

Detailed description

The epidemic of excess weight in childhood is impacted by exposure to, and consumption of, fast food and calorie dense foods prepared outside of the home. Black youth are more likely than their peers to live in communities with a high density of fast food restaurants. There is a need for interventions to help adolescents make healthy choices in these obesogenic environments. Previous research revealed that adolescents welcomed health-related text messages (based on Self Determination Theory and Motivational Interviewing) if they viewed them as personally relevant and if they were received at times when they faced dietary choices. Based on these findings, the following is hypothesized: that delivering messages (tailored to users' preferences and values) at a time and place when they are making a dietary choice (e.g., in a restaurant) will positively influence their choices. Thus, the Location Initiated Individualized Texts for African American Adolescent Health (LIITA3H) mobile application was developed. This app identifies when users were in a restaurant, automatically sends culturally relevant messages (based on focus group input from the target population) tailored to user preferences and the menu options at their location with the aim of prompting users to make a healthy choice, and allows users to submit an annotated photo response about their food choice. For this R21 project the following will be achieved: 1) the LIITA3H app will be enhanced by incorporating user input regarding its design and by allowing greater automation in the identification of eating venues, and 2) the impact of the app on the number of visits by users to restaurants, and on the number of calories users consume from these venues will be tested. This will provide data regarding effect size and will form the foundation for a large randomized trial in a larger population and including a greater range of eating venues. A better understanding of how 'just in time personalized cues to action, made possible by new location-based technology, might alter behavior among a high risk population, will help future efforts to address obesity and other illnesses impacted by lifestyle choices. As of 2020, due to the influence of the public health emergency, lockdowns prevented any participants from engaging in going to restaurants as they previously would have. Due to the trial beginning in November 2019, no six month app based data was acquired before the lockdown, and research limitations were imposed. When behavioral research of this type was allowed to resume, months later, a very limited time remained before the funded study would have to end. Thus, certain aspects of the protocol and intervention were modified. To be pragmatic under these constrained circumstances, for new participants, the intervention was shortened from 6 months to 1 month. As behavioral change takes longer to be achieved, the 1 month abbreviated trial focused on exploring the functionality of the app to lay the groundwork for future studies.

Interventions

OTHERFull LIITA3H App

This is the full version of the LIITA3H mobile app that will use 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 will allow participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.

OTHERPartial LIITA3H App

This is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food.

OTHERLIITA3H Location only

This is a version of the LIITA3H mobile app that will only track participants' location.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Self identification as African American * BMI at or above 85th percentile * Eat at fast food restaurants at least 3 times per week at baseline

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Visits to Fast Food RestaurantsOver 6 monthsChange in number of weekly visits to Fast Food Restaurants
Calories Purchased From Fast Food RestaurantsAfter 6 months of app useChange in number of calories purchased per week at Fast Food Restaurants
Percentage of Times App Identifies Presence in Fast Food Restaurant (FFR)Over 6 monthsPercentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.
Percentage of Times App Delivers Appropriate Tailored Messageover 1 monthPercentage 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).

Secondary

MeasureTime frameDescription
Participants' Perception of the Experience of Using the AppAt the completion of at least 1 month in the studyParticipants' 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
7
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.
7
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.
5
Total19

Baseline characteristics

CharacteristicIntervention Group 1 Full LIITA3H AppControl Group 2 Partial LIITA3H AppControl Group 3 LIITA3H Location OnlyTotal
Age, Continuous15 years14 years15 years15 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants7 Participants5 Participants19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants7 Participants5 Participants19 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
7 participants7 participants5 participants19 participants
Sex: Female, Male
Female
6 Participants5 Participants2 Participants13 Participants
Sex: Female, Male
Male
1 Participants2 Participants3 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 70 / 5
other
Total, other adverse events
0 / 70 / 70 / 5
serious
Total, serious adverse events
0 / 70 / 70 / 5

Outcome results

Primary

Calories Purchased From Fast Food Restaurants

Change in number of calories purchased per week at Fast Food Restaurants

Time frame: After 6 months of app use

Population: 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.

Primary

Percentage of Times App Delivers Appropriate Tailored Message

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).

Time frame: over 1 month

Population: The population consisted of participants in the intervention arm

ArmMeasureValue (NUMBER)
Intervention Group 1 Full LIITA3H AppPercentage of Times App Delivers Appropriate Tailored Message100 percentage of times
Primary

Percentage of Times App Identifies Presence in Fast Food Restaurant (FFR)

Percentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.

Time frame: Over 6 months

Population: 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.

Primary

Visits to Fast Food Restaurants

Change in number of weekly visits to Fast Food Restaurants

Time frame: Over 6 months

Population: 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.

Secondary

Participants' Perception of the Experience of Using the App

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.

Time frame: At the completion of at least 1 month in the study

Population: Participants who completed the study final assessment interview.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention Group 1 Full LIITA3H AppParticipants' Perception of the Experience of Using the AppExperienced at Least One Difficulty with App Functioning5 Participants
Intervention Group 1 Full LIITA3H AppParticipants' Perception of the Experience of Using the AppEnjoyed Messages4 Participants
Intervention Group 1 Full LIITA3H AppParticipants' Perception of the Experience of Using the AppPossible Desire to Continue App Use4 Participants
Control Group 2 Partial LIITA3H AppParticipants' Perception of the Experience of Using the AppPossible Desire to Continue App UseNA Participants
Control Group 2 Partial LIITA3H AppParticipants' Perception of the Experience of Using the AppExperienced at Least One Difficulty with App Functioning2 Participants
Control Group 2 Partial LIITA3H AppParticipants' Perception of the Experience of Using the AppEnjoyed MessagesNA Participants
Control Group 3 LIITA3H Location OnlyParticipants' Perception of the Experience of Using the AppEnjoyed MessagesNA Participants
Control Group 3 LIITA3H Location OnlyParticipants' Perception of the Experience of Using the AppExperienced at Least One Difficulty with App Functioning0 Participants
Control Group 3 LIITA3H Location OnlyParticipants' Perception of the Experience of Using the AppPossible Desire to Continue App UseNA Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026