Overweight and ObesityLIITA3HNCT03693144
Improving Nutritional Choices in Adolescents
A study testing Full LIITA3H App, Partial LIITA3H App and LIITA3H Location only in people with Overweight and Obesity, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this project is to test whether the mobile application helps Black adolescents make healthy food choices at the point of purchase. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Full LIITA3H App, Partial LIITA3H App and LIITA3H Location only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Self identification as African American
- BMI at or above 85th percentile
- Eat at fast food restaurants at least 3 times per week at baseline
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Location Initiated Individualized Texts for African American Adolescent Health
The goal of this project is to test whether the mobile application helps Black adolescents make healthy food choices at the point of purchase.
Read the detailed description
The epidemic of excess weight in childhood is impacted by exposure to, and consumption of, fast food and calorie dense foods prepared outside of the home. Black youth are more likely than their peers to live in communities with a high density of fast food restaurants. There is a need for interventions to help adolescents make healthy choices in these obesogenic environments.
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: that 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 Location Initiated Individualized Texts for African American Adolescent Health (LIITA3H) mobile application was developed. This app identifies when users were in a restaurant, automatically sends culturally relevant messages (based on focus group input from the target population) 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.
For this R21 project the following will be achieved: 1) the LIITA3H app will be enhanced by incorporating user input regarding its design and by allowing greater automation in the identification of eating venues, and 2) the impact of the app on the number of visits by users to restaurants, and on the number of calories users consume from these venues will be tested. This will provide data regarding effect size and will form the foundation for a large randomized trial in a larger population and including a greater range of eating venues. A better understanding of how 'just in time" personalized cues to action, made possible by new location-based technology, might alter behavior among a high risk population, will help future efforts to address obesity and other illnesses impacted by lifestyle choices.
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 November 2019, 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, months later, a very 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, for new participants, the intervention was shortened from 6 months to 1 month. As behavioral change takes longer to be achieved, the 1 month abbreviated trial focused on exploring the functionality of the app to lay the groundwork for future studies.
- Conditions
- Overweight and Obesity
- Being tested
- Full LIITA3H App, Partial LIITA3H App, LIITA3H Location only
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full LIITA3H AppOther
This is the full version of the LIITA3H mobile app that will use the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and will allow participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.
Partial LIITA3H AppOther
This is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food.
LIITA3H Location onlyOther
This is a version of the LIITA3H mobile app that will only track participants' location.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 Full LIITA3H App | Experimental | Participants were given the LIITA3H app, which is a combination product consisting of 3 main features that tracked their visits to fast food restaurants (using the ELI feature), sent tailored text messages to prompt healthy choices when they were in a fast food restaurant (using the POP feature), and allowed them to submit pictures of their food (using the SNAP feature). Receives: Other: Full LIITA3H App |
| Control Group 2 Partial LIITA3H App | Active comparator | Participants were given the LIITA3H app that tracked their visits to fast food restaurants (using the ELI feature) and they submitted pictures of their food (using the SNAP feature). However, they did not receive tailored text messages. Receives: Other: Partial LIITA3H App |
| Control Group 3 LIITA3H Location only | Other | Participants were given the LIITA3H app that tracked their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food. Receives: Other: LIITA3H Location only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visits to Fast Food Restaurants
Change in number of weekly visits to Fast Food Restaurants
Measured: Over 6 months
Calories Purchased From Fast Food Restaurants
Change in number of calories purchased per week at Fast Food Restaurants
Measured: After 6 months of app use
Percentage of Times App Identifies Presence in Fast Food Restaurant (FFR)
Percentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.
Measured: Over 6 months
Percentage of Times App Delivers Appropriate Tailored Message
Percentage of times the app delivers a tailored message for a menu item at the Fast Food Restaurant in which the participant is located. (number of times a tailored message is delivered divided by the number of times the app identified that the user was in a Fast Food Restaurant x 100).
Measured: over 1 month
Secondary outcomes (1)
Participants' Perception of the Experience of Using the App
Participants' perception of the acceptability of the app's content and design via qualitative assessment. While the original intent for this outcome measure was to assess perceptions after 6 months of app use, because of the constraints of COVID, these interviews were primarily performed after a single month in the study.
Measured: At the completion of at least 1 month in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start25 Nov 2019
- Primary completion25 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Susan J Woolford, MD, MPH, University of Michigan
- Investigators
- Susan J Woolford, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693144
- Sponsor's protocol ID
- HUM00083980
- Other IDs
- 1R21HD093835-01
- Acronym
- LIITA3H
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2018
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location Initiated Individualized Texts for African American Adolescent Health
- ClinicalTrials.gov ID
- NCT03693144
- Acronym / sponsor ID
- LIITA3H / HUM00083980
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to test whether the mobile application helps Black adolescents make healthy food choices at the point of purchase.
Detailed description
The epidemic of excess weight in childhood is impacted by exposure to, and consumption of, fast food and calorie dense foods prepared outside of the home. Black youth are more likely than their peers to live in communities with a high density of fast food restaurants. There is a need for interventions to help adolescents make healthy choices in these obesogenic environments.
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: that 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 Location Initiated Individualized Texts for African American Adolescent Health (LIITA3H) mobile application was developed. This app identifies when users were in a restaurant, automatically sends culturally relevant messages (based on focus group input from the target population) 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.
For this R21 project the following will be achieved: 1) the LIITA3H app will be enhanced by incorporating user input regarding its design and by allowing greater automation in the identification of eating venues, and 2) the impact of the app on the number of visits by users to restaurants, and on the number of calories users consume from these venues will be tested. This will provide data regarding effect size and will form the foundation for a large randomized trial in a larger population and including a greater range of eating venues. A better understanding of how 'just in time" personalized cues to action, made possible by new location-based technology, might alter behavior among a high risk population, will help future efforts to address obesity and other illnesses impacted by lifestyle choices.
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 November 2019, 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, months later, a very 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, for new participants, the intervention was shortened from 6 months to 1 month. As behavioral change takes longer to be achieved, the 1 month abbreviated trial focused on exploring the functionality of the app to lay the groundwork for future studies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 Full LIITA3H App | Experimental | Other: Full LIITA3H AppParticipants were given the LIITA3H app, which is a combination product consisting of 3 main features that tracked their visits to fast food restaurants (using the ELI feature), sent tailored text messages to prompt healthy choices when they were in a fast food restaurant (using the POP feature), and allowed them to submit pictures of their food (using the SNAP feature). |
| Control Group 2 Partial LIITA3H App | Active comparator | Other: Partial LIITA3H AppParticipants were given the LIITA3H app that tracked their visits to fast food restaurants (using the ELI feature) and they submitted pictures of their food (using the SNAP feature). However, they did not receive tailored text messages. |
| Control Group 3 LIITA3H Location only | Other | Other: LIITA3H Location onlyParticipants were given the LIITA3H app that tracked their visits to fast food restaurants (using the ELI feature) but they did not receive tailored messages or submit pictures of their food. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Self identification as African American
- BMI at or above 85th percentile
- Eat at fast food restaurants at least 3 times per week at baseline
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full LIITA3H AppThis is the full version of the LIITA3H mobile app that will use the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and will allow participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function. | Other | Intervention Group 1 Full LIITA3H App |
| Partial LIITA3H AppThis is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food. | Other | Control Group 2 Partial LIITA3H App |
| LIITA3H Location onlyThis is a version of the LIITA3H mobile app that will only track participants' location. | Other | Control Group 3 LIITA3H Location only |
Primary outcome
Visits to Fast Food Restaurants
Time frame: Over 6 months
Change in number of weekly visits to Fast Food Restaurants
Calories Purchased From Fast Food Restaurants
Time frame: After 6 months of app use
Change in number of calories purchased per week at Fast Food Restaurants
Percentage of Times App Identifies Presence in Fast Food Restaurant (FFR)
Time frame: Over 6 months
Percentage of times the app correctly identifies that a participant is in a registered Fast Food Restaurant.
Percentage of Times App Delivers Appropriate Tailored Message
Time frame: over 1 month
Percentage of times the app delivers a tailored message for a menu item at the Fast Food Restaurant in which the participant is located. (number of times a tailored message is delivered divided by the number of times the app identified that the user was in a Fast Food Restaurant x 100).
1 secondary outcome
Participants' Perception of the Experience of Using the App
Time frame: At the completion of at least 1 month in the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Overweight and Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Woolford, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full LIITA3H App, Partial LIITA3H App and LIITA3H Location only in people with Overweight and Obesity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visits to Fast Food Restaurants (time frame: Over 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.