Trial Outcomes & Findings for Location Initiated Individualized Texts for Adolescent Health (LIITAH) (NCT NCT03762135)
NCT ID: NCT03762135
Last Updated: 2024-08-26
Results Overview
Number of visits will be obtained from the app. This outcome measure is based exclusively on adolescent data.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
over 6 weeks
Results posted on
2024-08-26
Participant Flow
78 parents were also consented on behalf of their children and were interviewed after data was collected for their child for qualitative, non-health-outcome related measures. Therefore, they are not included as an arm as no intervention was received.
Participant milestones
| Measure |
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
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.
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
26
|
|
Overall Study
COMPLETED
|
52
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only participants who identified as African American, Hispanic, or multiple races including African American were administered this survey.
Baseline characteristics by cohort
| Measure |
Full Version of the LIITah App.
n=52 Participants
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
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.
|
Partial App. (ELI and SNAP Only)
n=26 Participants
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.
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
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 years
n=52 Participants
|
15 years
n=26 Participants
|
15 years
n=78 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=52 Participants
|
15 Participants
n=26 Participants
|
53 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=52 Participants
|
11 Participants
n=26 Participants
|
25 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=52 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=52 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=52 Participants
|
5 Participants
n=26 Participants
|
15 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=52 Participants
|
17 Participants
n=26 Participants
|
50 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=52 Participants
|
3 Participants
n=26 Participants
|
10 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=52 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=52 Participants
|
2 Participants
n=26 Participants
|
8 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=52 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic, Latino, or Middle Eastern
|
45 Participants
n=52 Participants
|
24 Participants
n=26 Participants
|
69 Participants
n=78 Participants
|
|
Region of Enrollment
United States
|
52 parents of participants
n=52 Participants
|
26 parents of participants
n=26 Participants
|
78 parents of participants
n=78 Participants
|
|
Estimated number of fast food restaurant visits per week prior to study
|
5 FFR Visits
n=52 Participants
|
5 FFR Visits
n=26 Participants
|
5 FFR Visits
n=78 Participants
|
|
BMI Percentile
|
87.2 BMI (kg/m^2) Percentile
n=52 Participants
|
87.4 BMI (kg/m^2) Percentile
n=26 Participants
|
87.3 BMI (kg/m^2) Percentile
n=78 Participants
|
|
Ethnic Identity Score
|
3.2 units on a scale
n=21 Participants • Only participants who identified as African American, Hispanic, or multiple races including African American were administered this survey.
|
3.0 units on a scale
n=8 Participants • Only participants who identified as African American, Hispanic, or multiple races including African American were administered this survey.
|
3.2 units on a scale
n=29 Participants • Only participants who identified as African American, Hispanic, or multiple races including African American were administered this survey.
|
PRIMARY outcome
Timeframe: over 6 weeksNumber of visits will be obtained from the app. This outcome measure is based exclusively on adolescent data.
Outcome measures
| Measure |
Full Version of the LIITah App.
n=52 Participants
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
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.
|
Partial App. (ELI and SNAP Only)
n=26 Participants
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.
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
|
|---|---|---|
|
Visits to Restaurants
Week 1
|
3.1 Number of FFR Visits
Standard Deviation 3
|
2.6 Number of FFR Visits
Standard Deviation 2
|
|
Visits to Restaurants
Week 2
|
2.9 Number of FFR Visits
Standard Deviation 2.6
|
2.6 Number of FFR Visits
Standard Deviation 2.1
|
|
Visits to Restaurants
Week 3
|
2.5 Number of FFR Visits
Standard Deviation 2.3
|
2.1 Number of FFR Visits
Standard Deviation 1.5
|
|
Visits to Restaurants
Week 4
|
1.9 Number of FFR Visits
Standard Deviation 2.1
|
2.1 Number of FFR Visits
Standard Deviation 1.3
|
|
Visits to Restaurants
Week 5
|
2 Number of FFR Visits
Standard Deviation 2.1
|
1.7 Number of FFR Visits
Standard Deviation 1.7
|
|
Visits to Restaurants
Week 6
|
1.6 Number of FFR Visits
Standard Deviation 1.7
|
1.6 Number of FFR Visits
Standard Deviation 1
|
PRIMARY outcome
Timeframe: over 6 weeksNumber 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.
Outcome measures
| Measure |
Full Version of the LIITah App.
n=52 Participants
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
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.
|
Partial App. (ELI and SNAP Only)
n=26 Participants
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.
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
|
|---|---|---|
|
Calories Purchased From Restaurants
Week 1
|
2432 Calories
Interval 1927.0 to 2936.0
|
2035 Calories
Interval 1570.0 to 2500.0
|
|
Calories Purchased From Restaurants
Week 2
|
2162 Calories
Interval 1740.0 to 2583.0
|
1982 Calories
Interval 1611.0 to 2352.0
|
|
Calories Purchased From Restaurants
Week 3
|
1892 Calories
Interval 1531.0 to 2252.0
|
1929 Calories
Interval 1584.0 to 2274.0
|
|
Calories Purchased From Restaurants
Week 4
|
1622 Calories
Interval 1288.0 to 1955.0
|
1876 Calories
Interval 1475.0 to 2277.0
|
|
Calories Purchased From Restaurants
Week 5
|
1352 Calories
Interval 1002.0 to 1701.0
|
1823 Calories
Interval 1310.0 to 2335.0
|
|
Calories Purchased From Restaurants
Week 6
|
1082 Calories
Interval 679.0 to 1484.0
|
1769 Calories
Interval 1117.0 to 2422.0
|
SECONDARY outcome
Timeframe: 6 weeksHeight and weight will be obtained. This outcome measure is based exclusively on adolescent data.
Outcome measures
| Measure |
Full Version of the LIITah App.
n=52 Participants
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
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.
|
Partial App. (ELI and SNAP Only)
n=26 Participants
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.
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
|
|---|---|---|
|
Body Mass Index (BMI) Percentile
|
85.4 BMI (kg/m2) percentile
Interval 48.7 to 99.9
|
88.1 BMI (kg/m2) percentile
Interval 47.4 to 99.6
|
Adverse Events
Full Version of the LIITah App. (Adolescents)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Full Version of the LIITah App.(Parents)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Partial App. (ELI and SNAP Only) (Adolescents)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Partial App. (ELI and SNAP Only) - Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place