Location Initiated Individualized Texts for Adolescent Health (LIITAH)

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT03762135

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

300

Enrollment

Location

Arms

20.9

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obese Healthy	Other: Full version of the LIITah App. Other: Partial App. (ELI and SNAP only)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Location Initiated Individualized Texts for Adolescent Health (LIITAH)

Actual Study Start Date :

Mar 4, 2021

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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.
Active Comparator: 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.	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

Arm

Intervention/Treatment

Experimental: 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

Other: 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.

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

Visits to restaurants [over 6 months]
number of visits will be obtained from the app.
Calories purchased from restaurants [over 6 months]
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) [baseline, 6 months]
height and weight will be obtained

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: Susan J Woolford, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Susan J Woolford, MD, MPH, Assistant Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT03762135

Other Study ID Numbers:

HUM0000143430
2R42MD008840-02

First Posted:

Dec 3, 2018

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Aug 24, 2022