Healthy, Obese, Overweight
Conditions
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 weeks.
Detailed description
Excess weight puts millions of adolescents in the US at risk for weight-related illnesses and premature death and disproportionately impacts Black and Hispanic populations. Black and Hispanic youth are more likely to be exposed to communities with high densities of fast-food restaurants. This project sought to help adolescents make healthy choices in obesogenic settings that are relevant to and have been tested in populations who are at the highest risk for obesity and its associated costs. Previous research revealed that adolescents welcomed health-related text messages (based on Self Determination Theory and Motivational Interviewing) if they viewed them as personally relevant and if they were received at times when they faced dietary choices. Based on these findings, the following is hypothesized: delivering messages (tailored to users' preferences and values) at a time and place when they are making a dietary choice (e.g., in a restaurant) will positively influence their choices. Thus, the Health Kick+ App was developed, and it aimed to deliver tailored messages at the point of purchase. This app identifies when users are in a restaurant, automatically sends culturally relevant messages tailored to user preferences and the menu options at their location with the aim of prompting users to make a healthy choice, and allows users to submit an annotated photo response about their food choice. Participants were recruited as parent/guardian and teen dyads. Teen participants also were allowed to set goals, see progress reports, and receive daily health tips. Parent/guardian participants could communicate with the teen via the app and monitor progress. This project worked towards enhancing the earlier version of the app developed in the LIITA3H study. The LIITAH study worked towards developing 1) deeper individual tailoring, making the content even more relevant to users from different races/ethnicities; 2) a dyad capability for parents to use the app coordinated with their adolescent; and 3) additional engagement features to remind participants to use the app frequently. As of 2020, due to the influence of the public health emergency, lockdowns prevented any participants from engaging in going to restaurants as they previously would have. Due to the trial beginning in 2021, no six-month app-based data was acquired before the lockdown, and research limitations were imposed. When behavioral research of this type was allowed to resume, limited time remained before the funded study would have to end. Thus, certain aspects of the protocol and intervention were modified. To be pragmatic under these constrained circumstances, the intervention was shortened from 6 months to 6 weeks.
Interventions
OTHERFull 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.
OTHERPartial 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
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* eat restaurant food at least 3 times a week and have a parent who agrees to participate.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visits to Restaurants | over 6 weeks | Number of visits will be obtained from the app. This outcome measure is based exclusively on adolescent data. |
| Calories Purchased From Restaurants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) Percentile | 6 weeks | Height and weight will be obtained. This outcome measure is based exclusively on adolescent data. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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 | 26 |
| Total | 78 |
Baseline characteristics
| Characteristic | Full Version of the LIITah App. | Partial App. (ELI and SNAP Only) | Total |
|---|---|---|---|
| Age, Continuous | 15 years | 15 years | 15 years |
| BMI Percentile | 87.2 BMI (kg/m^2) Percentile | 87.4 BMI (kg/m^2) Percentile | 87.3 BMI (kg/m^2) Percentile |
| Estimated number of fast food restaurant visits per week prior to study | 5 FFR Visits | 5 FFR Visits | 5 FFR Visits |
| Ethnic Identity Score | 3.2 units on a scale | 3.0 units on a scale | 3.2 units on a scale |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic, Latino, or Middle Eastern | 45 Participants | 24 Participants | 69 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 33 Participants | 17 Participants | 50 Participants |
| Region of Enrollment United States | 52 parents of participants | 26 parents of participants | 78 parents of participants |
| Sex: Female, Male Female | 38 Participants | 15 Participants | 53 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 52 | 0 / 52 | 0 / 26 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 | 0 / 26 | 0 / 52 |
Outcome results
Primary
Calories Purchased From Restaurants
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.
Time frame: over 6 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Full Version of the LIITah App. | Calories Purchased From Restaurants | Week 1 | 2432 Calories |
| Full Version of the LIITah App. | Calories Purchased From Restaurants | Week 2 | 2162 Calories |
| Full Version of the LIITah App. | Calories Purchased From Restaurants | Week 3 | 1892 Calories |
| Full Version of the LIITah App. | Calories Purchased From Restaurants | Week 4 | 1622 Calories |
| Full Version of the LIITah App. | Calories Purchased From Restaurants | Week 5 | 1352 Calories |
| Full Version of the LIITah App. | Calories Purchased From Restaurants | Week 6 | 1082 Calories |
| Partial App. (ELI and SNAP Only) | Calories Purchased From Restaurants | Week 5 | 1823 Calories |
| Partial App. (ELI and SNAP Only) | Calories Purchased From Restaurants | Week 1 | 2035 Calories |
| Partial App. (ELI and SNAP Only) | Calories Purchased From Restaurants | Week 4 | 1876 Calories |
| Partial App. (ELI and SNAP Only) | Calories Purchased From Restaurants | Week 2 | 1982 Calories |
| Partial App. (ELI and SNAP Only) | Calories Purchased From Restaurants | Week 6 | 1769 Calories |
| Partial App. (ELI and SNAP Only) | Calories Purchased From Restaurants | Week 3 | 1929 Calories |
p-value: 0.044GEE Linear Regression
Primary
Visits to Restaurants
Number of visits will be obtained from the app. This outcome measure is based exclusively on adolescent data.
Time frame: over 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Version of the LIITah App. | Visits to Restaurants | Week 1 | 3.1 Number of FFR Visits | Standard Deviation 3 |
| Full Version of the LIITah App. | Visits to Restaurants | Week 2 | 2.9 Number of FFR Visits | Standard Deviation 2.6 |
| Full Version of the LIITah App. | Visits to Restaurants | Week 3 | 2.5 Number of FFR Visits | Standard Deviation 2.3 |
| Full Version of the LIITah App. | Visits to Restaurants | Week 4 | 1.9 Number of FFR Visits | Standard Deviation 2.1 |
| Full Version of the LIITah App. | Visits to Restaurants | Week 5 | 2 Number of FFR Visits | Standard Deviation 2.1 |
| Full Version of the LIITah App. | Visits to Restaurants | Week 6 | 1.6 Number of FFR Visits | Standard Deviation 1.7 |
| Partial App. (ELI and SNAP Only) | Visits to Restaurants | Week 5 | 1.7 Number of FFR Visits | Standard Deviation 1.7 |
| Partial App. (ELI and SNAP Only) | Visits to Restaurants | Week 1 | 2.6 Number of FFR Visits | Standard Deviation 2 |
| Partial App. (ELI and SNAP Only) | Visits to Restaurants | Week 4 | 2.1 Number of FFR Visits | Standard Deviation 1.3 |
| Partial App. (ELI and SNAP Only) | Visits to Restaurants | Week 2 | 2.6 Number of FFR Visits | Standard Deviation 2.1 |
| Partial App. (ELI and SNAP Only) | Visits to Restaurants | Week 6 | 1.6 Number of FFR Visits | Standard Deviation 1 |
| Partial App. (ELI and SNAP Only) | Visits to Restaurants | Week 3 | 2.1 Number of FFR Visits | Standard Deviation 1.5 |
Secondary
Body Mass Index (BMI) Percentile
Height and weight will be obtained. This outcome measure is based exclusively on adolescent data.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Full Version of the LIITah App. | Body Mass Index (BMI) Percentile | 85.4 BMI (kg/m2) percentile |
| Partial App. (ELI and SNAP Only) | Body Mass Index (BMI) Percentile | 88.1 BMI (kg/m2) percentile |