NCT03762135

Location Initiated Individualized Texts for Adolescent Health (LIITAH)

Completed NA Results posted Last updated 26 August 2024

What this trial tests

NA trial testing Full version of the LIITah App. in Overweight in 156 participants. Completed in 21 November 2022.

Timeline

4 March 2021

Primary endpoint
21 November 2022

21 November 2022

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	4 March 2021
Primary completion	21 November 2022
Estimated completion	21 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Full version of the LIITah App.
• Partial App. (ELI and SNAP only)

Conditions studied

• Overweight — all drugs for Overweight →
• Obese — all drugs for Obese →
• Healthy — all drugs for Healthy →

Sponsor

University of Michigan

Who can join

Adults 13 to 17, any sex, with Overweight or Obese. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visits to Restaurants Primary · over 6 weeks

Number of visits will be obtained from the app. This outcome measure is based exclusively on adolescent data.

Week 1

Group	Value	95% CI
Full Version of the LIITah App.	3.1	± 3
Partial App. (ELI and SNAP Only)	2.6	± 2

Week 2

Group	Value	95% CI
Full Version of the LIITah App.	2.9	± 2.6
Partial App. (ELI and SNAP Only)	2.6	± 2.1

Week 3

Group	Value	95% CI
Full Version of the LIITah App.	2.5	± 2.3
Partial App. (ELI and SNAP Only)	2.1	± 1.5

Week 4

Group	Value	95% CI
Full Version of the LIITah App.	1.9	± 2.1
Partial App. (ELI and SNAP Only)	2.1	± 1.3

Week 5

Group	Value	95% CI
Full Version of the LIITah App.	2	± 2.1
Partial App. (ELI and SNAP Only)	1.7	± 1.7

Week 6

Group	Value	95% CI
Full Version of the LIITah App.	1.6	± 1.7
Partial App. (ELI and SNAP Only)	1.6	± 1

Calories Purchased From Restaurants Primary · over 6 weeks

Number of calories purchased by the adolescent and for the adolescent were assessed using annotated photos, and nutritional data from the restaurant menus. This analysis used population averaged generalized estimating equation regressions (GEE) to compare trajectories of calories purchased between groups. The GEE approach allowed for the correlation in repeated observations collected from participants over time. This outcome measure is based exclusively on adolescent data.

Week 1

Group	Value	95% CI
Full Version of the LIITah App.	2432	1927 – 2936
Partial App. (ELI and SNAP Only)	2035	1570 – 2500

Week 2

Group	Value	95% CI
Full Version of the LIITah App.	2162	1740 – 2583
Partial App. (ELI and SNAP Only)	1982	1611 – 2352

Week 3

Group	Value	95% CI
Full Version of the LIITah App.	1892	1531 – 2252
Partial App. (ELI and SNAP Only)	1929	1584 – 2274

Week 4

Group	Value	95% CI
Full Version of the LIITah App.	1622	1288 – 1955
Partial App. (ELI and SNAP Only)	1876	1475 – 2277

Week 5

Group	Value	95% CI
Full Version of the LIITah App.	1352	1002 – 1701
Partial App. (ELI and SNAP Only)	1823	1310 – 2335

Week 6

Group	Value	95% CI
Full Version of the LIITah App.	1082	679 – 1484
Partial App. (ELI and SNAP Only)	1769	1117 – 2422

Body Mass Index (BMI) Percentile Secondary · 6 weeks

Height and weight will be obtained. This outcome measure is based exclusively on adolescent data.

Group	Value	95% CI
Full Version of the LIITah App.	85.4	48.7 – 99.9
Partial App. (ELI and SNAP Only)	88.1	47.4 – 99.6

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions to prevent obesity in children aged 12 to 18 years old.
   Spiga F, Tomlinson E, Davies AL, Moore TH, et al · · 2024 · cited 30× · PMID 38763518 · DOI 10.1002/14651858.cd015330.pub2