Improving Nutritional Choices in Adolescents

NCT ID: NCT03693144

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2021-05-01

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Full LIITA3H App

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Partial LIITA3H App

Intervention Type: OTHER

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

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.

Group Type: OTHER

LIITA3H Location only

Intervention Type: OTHER

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

Interventions

Full 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.

Intervention Type: OTHER

Partial 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.

Intervention Type: OTHER

LIITA3H Location only

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

Intervention Type: OTHER

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

-

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Susan J Woolford, MD, MPH

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan J Woolford, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21HD093835-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00083980

Identifier Type: -

Identifier Source: org_study_id