Improving Nutritional Choices in Adolescents (LIITA3H)

October 18, 2022 updated by: Susan J Woolford, MD, MPH, University of Michigan

Location Initiated Individualized Texts for African American Adolescent Health

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group 1 Full LIITA3H App
Participants were given the LIITA3H app, which is a combination product consisting of 3 main features that tracked their visits to fast food restaurants (using the ELI feature), sent tailored text messages to prompt healthy choices when they were in a fast food restaurant (using the POP feature), and allowed them to submit pictures of their food (using the SNAP feature).
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.
Active Comparator: Control Group 2 Partial LIITA3H App
Participants were given the LIITA3H app that tracked their visits to fast food restaurants (using the ELI feature) and they submitted pictures of their food (using the SNAP feature). However, they did not receive tailored text messages.
This is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food.
Other: Control Group 3 LIITA3H Location only
Participants were given the LIITA3H app that tracked their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food.
This is a version of the LIITA3H mobile app that will only track participants' location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visits to Fast Food Restaurants
Time Frame: Over 6 months
Change in number of weekly visits to Fast Food Restaurants
Over 6 months
Calories Purchased From Fast Food Restaurants
Time Frame: After 6 months of app use
Change in number of calories purchased per week at Fast Food Restaurants
After 6 months of app use
Percentage of Times App Identifies Presence in Fast Food Restaurant (FFR)
Time Frame: Over 6 months
Percentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.
Over 6 months
Percentage of Times App Delivers Appropriate Tailored Message
Time Frame: over 1 month
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).
over 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Perception of the Experience of Using the App
Time Frame: At the completion of at least 1 month in the study
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.
At the completion of at least 1 month in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan J Woolford, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2019

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00083980
  • 1R21HD093835-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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