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Location Initiated Individualized Texts for Adolescent Health (LIITAH)

Primary Purpose

Overweight, Obese, Healthy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Full version of the LIITah App.

Partial App. (ELI and SNAP only)

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full version of the LIITah App.

Partial App. (ELI and SNAP only)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Visits to restaurants

number of visits will be obtained from the app.

Calories purchased from restaurants

number of calories purchased by the adolescent and for the adolescent will be assessed using annotated photos, and nutritional data from the restaurant menus.

Secondary Outcome Measures

Change in body mass index (BMI)

height and weight will be obtained

Full Information

NCT ID

NCT03762135

First Posted

November 30, 2018

Last Updated

January 31, 2023

Sponsor

University of Michigan

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT03762135

Brief Title

Location Initiated Individualized Texts for Adolescent Health (LIITAH)

Official Title

Location Initiated Individualized Texts for Adolescent Health (LIITAH)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

March 4, 2021 (Actual)

Primary Completion Date

November 21, 2022 (Actual)

Study Completion Date

November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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 months.

6. Conditions and Keywords

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

Overweight, Obese, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Full version of the LIITah App.

Arm Type

Experimental

Arm Description

Arm Title

Partial App. (ELI and SNAP only)

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Full version of the LIITah App.

Intervention Description

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

Intervention Name(s)

Partial App. (ELI and SNAP only)

Intervention Description

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

Primary Outcome Measure Information:

Title

Visits to restaurants

Description

number of visits will be obtained from the app.

Time Frame

over 6 months

Title

Calories purchased from restaurants

Description

number of calories purchased by the adolescent and for the adolescent will be assessed using annotated photos, and nutritional data from the restaurant menus.

Time Frame

over 6 months

Secondary Outcome Measure Information:

Title

Change in body mass index (BMI)

Description

height and weight will be obtained

Time Frame

baseline, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Learn more about this trial

Location Initiated Individualized Texts for Adolescent Health (LIITAH)

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