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Location Initiated Individualized Texts for Adolescent Health (LIITAH)

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ClinicalTrials.gov Identifier: NCT03762135
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Susan J Woolford, MD, MPH, University of Michigan

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : July 15, 2020

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




Primary Outcome Measures :
  1. Visits to restaurants [ Time Frame: over 6 months ]
    number of visits will be obtained from the app.

  2. Calories purchased from restaurants [ Time Frame: 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 :
  1. Change in body mass index (BMI) [ Time Frame: baseline, 6 months ]
    height and weight will be obtained



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762135


Contacts
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Contact: Susan J Woolford, MD 734-904-1455 swoolfor@med.umich.edu
Contact: Theresa Kowalski-Dobson, MPH 734-232-2455 tkowals@med.umich.edu

Locations
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United States, Michigan
University of Michigna Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Susan J Woolford, MD University of Michigan

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Responsible Party: Susan J Woolford, MD, MPH, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03762135     History of Changes
Other Study ID Numbers: HUM0000143430
2R42MD008840-02 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms