Improving Nutritional Choices in Adolescents

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Susan J Woolford, MD, MPH，University of Michigan

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visits to fast food restaurants[ Time Frame: Over 6 months ]

Decrease in number of weekly visits to fast food restaurants

Calories purchased from fast food restaurants[ Time Frame: Over 6 months ]

Decrease in number of calories purchased per week at fast food restaurants

Identification of presence in fast food restaurant[ Time Frame: Over 6 months ]

Percentage of times the app correctly identifies that a participant is in a registered fast food restaurant

Delivery of appropriate tailored message[ Time Frame: Over 6 months ]

Percentage of times the app delivers a tailored message for a menu item at the fast food restaurant in which the participant is located

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Acceptability[ Time Frame: At the completion of 6 months in the study ]
Participants' perception of the acceptability of the app's content and design on a Likert scale

Descriptive Information

Brief Title ^ICMJE

Improving Nutritional Choices in Adolescents

Official Title ^ICMJE

Location Initiated Individualized Texts for African American Adolescent Health

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Other: LIITA3H App with ELI, SNAP, and POP
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.
Other: LIITA3H App with ELI and SNAP
This is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food.
Other: LIITA3H App with ELI only
This is a version of the LIITA3H mobile app that will only track participants' location.

Study Arms

Experimental: Intervention Group 1 ELI, SNAP, and POP
Participants with have the app on their phone and it will track their visits to fast food restaurants, they will receive tailored text messages to prompt healthy choices when they are in a fast food restaurant and they will be asked to submit pictures of their food. This will be accomplished using the LIITA3H App with ELI, SNAP and POP
Active Comparator: Control Group 2 ELI and SNAP
Participants with have the app on their phone and it will track their visits to fast food restaurants and they will submit pictures of their food. However, they will not receive tailored text messages. This will be accomplished using the LIITA3H App with ELI and SNAP.
Other: Control Group 3 ELI only
Participants with have the app on their phone and it will track their visits to fast food restaurants but they will not receive tailored messages or submit pictures of their food. This will be accomplished with the LIITA3H App with ELI only.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

150

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 31, 2019

Estimated Primary Completion Date

October 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Sex/Gender

Sexes Eligible for Study:

All

Ages

13 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Susan J Woolford, MD, MPH，University of Michigan

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Susan J Woolford, MD University of Michigan

PRS Account

University of Michigan

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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