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Improving Nutritional Choices in Adolescents (LIITA3H)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full LIITA3H App
Partial LIITA3H App
LIITA3H Location only
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Intervention Group 1 Full LIITA3H App

Control Group 2 Partial LIITA3H App

Control Group 3 LIITA3H Location only

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Visits to Fast Food Restaurants
Change in number of weekly visits to Fast Food Restaurants
Calories Purchased From Fast Food Restaurants
Change in number of calories purchased per week at Fast Food Restaurants
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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2018
Last Updated
October 18, 2022
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03693144
Brief Title
Improving Nutritional Choices in Adolescents
Acronym
LIITA3H
Official Title
Location Initiated Individualized Texts for African American Adolescent Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group 1 Full LIITA3H App
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group 2 Partial LIITA3H App
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group 3 LIITA3H Location only
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Full LIITA3H App
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Partial LIITA3H App
Intervention Description
This is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food.
Intervention Type
Other
Intervention Name(s)
LIITA3H Location only
Intervention Description
This is a version of the LIITA3H mobile app that will only track participants' location.
Primary Outcome Measure Information:
Title
Visits to Fast Food Restaurants
Description
Change in number of weekly visits to Fast Food Restaurants
Time Frame
Over 6 months
Title
Calories Purchased From Fast Food Restaurants
Description
Change in number of calories purchased per week at Fast Food Restaurants
Time Frame
After 6 months of app use
Title
Percentage of Times App Identifies Presence in Fast Food Restaurant (FFR)
Description
Percentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.
Time Frame
Over 6 months
Title
Percentage of Times App Delivers Appropriate Tailored Message
Description
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
Secondary Outcome Measure Information:
Title
Participants' Perception of the Experience of Using the App
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Woolford, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Nutritional Choices in Adolescents

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