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Completed

NCT Number: NCT03693144

Improving Nutritional Choices in Adolescents

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

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Full LIITA3H App

Other

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.

Partial LIITA3H App

Other

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

LIITA3H Location only

Other

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

Primary outcomes

  1. Visits to Fast Food Restaurants

    Time frame: Over 6 months

    Change in number of weekly visits to Fast Food Restaurants

  2. 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

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Location Initiated Individualized Texts for African American Adolescent Health

Acronym: LIITA3H

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 2, 2018
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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