Location Initiated Individualized Texts for Adolescent Health (LIITAH)

NCT ID: NCT03762135

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2022-11-21

Brief Summary

The goal of this study is to test whether the mobile application (app.) helps adolescents make healthy food choices, decreasing calories purchased from restaurants, fewer number of visits to restaurants, and if it has an impact on their body mass index (BMI). Eligible adolescents will be enrolled in the study along with a parent for approximately 6 weeks.

Detailed Description

Excess weight puts millions of adolescents in the US at risk for weight-related illnesses and premature death and disproportionately impacts Black and Hispanic populations. Black and Hispanic youth are more likely to be exposed to communities with high densities of fast-food restaurants. This project sought to help adolescents make healthy choices in obesogenic settings that are relevant to and have been tested in populations who are at the highest risk for obesity and its associated costs.

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: 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 Health Kick+ App was developed, and it aimed to deliver tailored messages at the point of purchase. This app identifies when users are in a restaurant, automatically sends culturally relevant messages 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. Participants were recruited as parent/guardian and teen dyads. Teen participants also were allowed to set goals, see progress reports, and receive daily health tips. Parent/guardian participants could communicate with the teen via the app and monitor progress.

This project worked towards enhancing the earlier version of the app developed in the LIITA3H study. The LIITAH study worked towards developing 1) deeper individual tailoring, making the content even more relevant to users from different races/ethnicities; 2) a dyad capability for parents to use the app coordinated with their adolescent; and 3) additional engagement features to remind participants to use the app frequently.

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 2021, 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, 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, the intervention was shortened from 6 months to 6 weeks.

Conditions

Overweight; Obese; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full version of the LIITah App.

Participants will be given the LIITAH app. which consists of 1) enhanced location identification (ELI), 2) self reported nutrients by annotated photos (SNAP), 3) delivery of individually and culturally tailored point of purchase (POP) prompts along with tailored messages sent at other times of the day, 4) use of app. in connection with parents, 5) goal setting, 6) a point system

Group Type: EXPERIMENTAL

Full version of the LIITah App.

Intervention Type: OTHER

Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated.

Partial App. (ELI and SNAP only)

Participants will be given only the ELI and SNAP components. It will detect their presence in a restaurant and allow users to document their purchases by submitting annotated photos, but it will not deliver any POP prompts encouraging them to make healthy choices, or messages at other times of the day.

Group Type: ACTIVE_COMPARATOR

Partial App. (ELI and SNAP only)

Intervention Type: OTHER

Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases

Interventions

Full version of the LIITah App.

Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated.

Intervention Type: OTHER

Partial App. (ELI and SNAP only)

Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• eat restaurant food at least 3 times a week and have a parent who agrees to participate.

Exclusion Criteria

-

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

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

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

Document Type: Informed Consent Form

View Document

Other Identifiers

2R42MD008840-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM0000143430

Identifier Type: -

Identifier Source: org_study_id