Diet, HealthyNCT06360367
mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
A study testing HI-FLY Curriculum and HI-FLY Curriculum + PortionSize Ed app in people with Diet, Healthy, run by University of Hawaii at 1 site in United States.
Trial summary
The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- HI-FLY Curriculum and HI-FLY Curriculum + PortionSize Ed app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2024to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females
- Grades 6 to 8 students
- Attend the target school on Kauai, Hawaii
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Hawaii at Manoa
Honolulu, Hawaii, 96822
Chloe P Lozano, PhD, 808-956-7095, cpanizza@hawaii.edu
About this study
The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.
PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.
Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY.
Read the detailed description
PortionSize Ed is a dietary assessment and nutrition education app that was developed to assist youth in Hawaii with understanding and adhering to national dietary guidelines. For example, The Dietary Guidelines for Americans (DGA) are intended for a professional audience and MyPlate is an example of the consumer translation of these guidelines. PortionSize Ed allows users to automatically calculate and track adherence to MyPlate food group recommendations and provides real-time feedback to the user. Tracking dietary intake in real-time reduces the risk of recall bias, and the timely feedback helps users make decisions during real life situations.
The food group recommendations in PortionSize Ed are tailored based on the user's height, weight, age, sex, and activity level. PortionSize Ed allows users to take images of their food at the start and end of each eating occasion. Users are prompted to identify each food item in a "Before Photo" using a search function (e.g., apple, raw), and select a portion size from a drop-down menu (e.g., half cup, medium, large). These built-in tools and a nutrition database allow for immediate feedback to the user on adherence to recommended intake of food group servings, saturated fat, and added sugars after each eating occasion.
Images captured with PortionSize Ed are automatically sent to a secure web-based server. This allows authorized users, e.g., a Nutrition Educator, to login and review the images and offer support remotely if needed. In addition, trained human raters can analyze the food images, using the Remote Food Photography Method (RFPM), which is an analysis method validated in most study populations and settings. Participants are trained to include a physical reference marker in each image, which standardizes the distance and angle of the camera from the food and assists with the RFPM analysis. Educational videos in PortionSize Ed, are accessed via the Videos tab.
The Hawai'i-Food and Lifeskills for Youth (HI-FLY) is a healthy lifestyle program delivered in schools throughout Hawaii. Therefore, HI-FLY provides an ideal platform for disseminating PortionSize Ed and should ensure this evidence based mHealth tool is effectively accessed. The investigators hypothesize that coupling the PortionSize Ed app with HI-FLY will further improve diet quality among youth in Hawaii vs. the standard HI-FLY program alone.
The preliminary evaluation of PortionSize Ed in a lab-based setting was promising. However, before PortionSize Ed can be coupled with HI-FLY for improving diet quality among youth in Hawaii, a feasibility and preliminary efficacy trial is needed.
Primary objectives:
- Assess the feasibility, and acceptability of integrating PortionSize Ed into HI-FLY among Grades 6 to 8 students on Kauai, Hawaii.
- Assess the preliminary efficacy of integrating PortionSize Ed into HI-FLY for improving Healthy Eating Index (HEI)-2020 scores compared to the standard HI-FY among Grades 6 to 8 students on Kauai, Hawaii. The HEI-2020 score was chosen as it quantifies adherence to the DGA 2020-20259.
- Conditions
- Diet, Healthy
- Being tested
- HI-FLY Curriculum, HI-FLY Curriculum + PortionSize Ed app
- Keywords
- diet quality, HEI-2020 scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HI-FLY CurriculumBehavioural
Participants receive the standard HI-FLY Curriculum over 6 weeks.
HI-FLY Curriculum + PortionSize Ed appBehavioural
Participants receive the standard HI-FLY Curriculum over 6 weeks and the PortionSize Ed mobile app.
| Study group | Role | What they receive |
|---|---|---|
| usual HI-FLY curriculum (HI-FLY) | Active comparator | The HI-FLY curriculum includes 6 lessons of 1-2 hours each, over 6 weeks. Lesson topics include 1) safe food handling, 2) vegetables and fruits, 3) more meals at home, 4) a food guide, 5) move more every day, and 6) re-think your drink. Receives: Behavioral: HI-FLY Curriculum |
| HI-FLY integrated with the PortionSize Ed app (HI-FLY + PSEd). | Experimental | Participants will receive HI-FLY usual care and be provided with the PortionSize Ed mobile app for the entire study. Receives: Behavioral: HI-FLY Curriculum + PortionSize Ed app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Study enrollment
At least 65% of students in each classroom enroll in the study.
Measured: 8 weeks
Acceptability- User Satisfaction Survey (USS) scores and qualitative responses
The USS has nine quantitative questions, answered with a 6-point Likert scale, and rates satisfaction, ease of use, and adequacy of training. The USS also contains an open-ended question where participants can provide any additional comments. Both groups will complete this.
Measured: 8 weeks
Acceptability- Computer System Usability Questionnaire (CSUQ) scores
The CSUQ has 19 questions, answered using a 7-point Likert scale, to rate overall satisfaction, usefulness, information quality and interface quality. Both groups will complete this.
Measured: 8 weeks
Acceptability- PortionSize Ed app usage data
PortionSize Ed app usage data including number of meals logged and number of times the app was used. Only the HI-FLY + PSEd group will complete this.
Measured: 8 weeks
Acceptability- Reason for study drop out
Participant reports reason for study drop out.
Measured: 8 weeks
Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score
Change in total HEI-2020 score for each study arm. Ranges from 0 to 100 with 100 being the highest score.
Measured: 8 weeks
Efficacy- Change in HEI-2020 component scores
Change in HEI-2020 component scores for each study arm. There are 13 component scores which are summed to give the total HEI-2020 score of 100.
Measured: 8 weeks
Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey
Change in healthy eating behavior scores between baseline and the final visit for both study arms.
Measured: 8 weeks
Feasibility- Study Attrition
No more than 15% study attrition.
Measured: 8 weeks
Secondary outcomes (1)
Change in body weight
Mean change in body weight between the baseline and final study visit.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start23 Apr 2024 (estimated)
- Primary completion22 Oct 2024 (estimated)
- Study completion22 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Chloe Lozano, University of Hawaii
- Investigators
- Chloe P Lozano, PhD, Principal investigator, University of Hawaii at Manoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360367
- Sponsor's protocol ID
- 2023-00060
- Other IDs
- 2023
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI, Dr. Lozano, is committed to sharing de-identified data with other researchers. The PI will share data with other investigators and/or potential collaborators even during the life of an ongoing grant and before the primary paper generated from grant work is accepted for publication from the project, though would ask for secondary papers to be submitted after a grant's main paper is accepted for publication. Also, as required by an increasing number of journals, the PI will fully comply with data posting guidelines for accepted papers that require the submission of de-identified data to a repository once the paper is accepted where those data can be downloaded by the general public. The PI is committed to sharing data generated by this grant with as few limitations as possible within compliance rules.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
- ClinicalTrials.gov ID
- NCT06360367
- Acronym / sponsor ID
- 2023-00060
- Conditions
- Diet, Healthy
- Keywords
- diet quality, HEI-2020 scores
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Pennington Biomedical Research Center
- Study start
- 23 Apr 2024 (estimated)
- Primary completion
- 22 Oct 2024 (estimated)
- Study completion
- 22 Oct 2024 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
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 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.
PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.
Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY.
Detailed description
PortionSize Ed is a dietary assessment and nutrition education app that was developed to assist youth in Hawaii with understanding and adhering to national dietary guidelines. For example, The Dietary Guidelines for Americans (DGA) are intended for a professional audience and MyPlate is an example of the consumer translation of these guidelines. PortionSize Ed allows users to automatically calculate and track adherence to MyPlate food group recommendations and provides real-time feedback to the user. Tracking dietary intake in real-time reduces the risk of recall bias, and the timely feedback helps users make decisions during real life situations.
The food group recommendations in PortionSize Ed are tailored based on the user's height, weight, age, sex, and activity level. PortionSize Ed allows users to take images of their food at the start and end of each eating occasion. Users are prompted to identify each food item in a "Before Photo" using a search function (e.g., apple, raw), and select a portion size from a drop-down menu (e.g., half cup, medium, large). These built-in tools and a nutrition database allow for immediate feedback to the user on adherence to recommended intake of food group servings, saturated fat, and added sugars after each eating occasion.
Images captured with PortionSize Ed are automatically sent to a secure web-based server. This allows authorized users, e.g., a Nutrition Educator, to login and review the images and offer support remotely if needed. In addition, trained human raters can analyze the food images, using the Remote Food Photography Method (RFPM), which is an analysis method validated in most study populations and settings. Participants are trained to include a physical reference marker in each image, which standardizes the distance and angle of the camera from the food and assists with the RFPM analysis. Educational videos in PortionSize Ed, are accessed via the Videos tab.
The Hawai'i-Food and Lifeskills for Youth (HI-FLY) is a healthy lifestyle program delivered in schools throughout Hawaii. Therefore, HI-FLY provides an ideal platform for disseminating PortionSize Ed and should ensure this evidence based mHealth tool is effectively accessed. The investigators hypothesize that coupling the PortionSize Ed app with HI-FLY will further improve diet quality among youth in Hawaii vs. the standard HI-FLY program alone.
The preliminary evaluation of PortionSize Ed in a lab-based setting was promising. However, before PortionSize Ed can be coupled with HI-FLY for improving diet quality among youth in Hawaii, a feasibility and preliminary efficacy trial is needed.
Primary objectives:
- Assess the feasibility, and acceptability of integrating PortionSize Ed into HI-FLY among Grades 6 to 8 students on Kauai, Hawaii.
- Assess the preliminary efficacy of integrating PortionSize Ed into HI-FLY for improving Healthy Eating Index (HEI)-2020 scores compared to the standard HI-FY among Grades 6 to 8 students on Kauai, Hawaii. The HEI-2020 score was chosen as it quantifies adherence to the DGA 2020-20259.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual HI-FLY curriculum (HI-FLY) | Active comparator | Behavioral: HI-FLY CurriculumThe HI-FLY curriculum includes 6 lessons of 1-2 hours each, over 6 weeks. Lesson topics include 1) safe food handling, 2) vegetables and fruits, 3) more meals at home, 4) a food guide, 5) move more every day, and 6) re-think your drink. |
| HI-FLY integrated with the PortionSize Ed app (HI-FLY + PSEd). | Experimental | Behavioral: HI-FLY Curriculum + PortionSize Ed appParticipants will receive HI-FLY usual care and be provided with the PortionSize Ed mobile app for the entire study. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Males or females
- Grades 6 to 8 students
- Attend the target school on Kauai, Hawaii
Key exclusion criteria (1 listed)
- No additional exclusion criteria
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 |
|---|---|---|
| HI-FLY CurriculumParticipants receive the standard HI-FLY Curriculum over 6 weeks. | Behavioural | usual HI-FLY curriculum (HI-FLY) |
| HI-FLY Curriculum + PortionSize Ed appParticipants receive the standard HI-FLY Curriculum over 6 weeks and the PortionSize Ed mobile app. | Behavioural | HI-FLY integrated with the PortionSize Ed app (HI-FLY + PSEd). |
Primary outcome
Feasibility- Study enrollment
Time frame: 8 weeks
At least 65% of students in each classroom enroll in the study.
Acceptability- User Satisfaction Survey (USS) scores and qualitative responses
Time frame: 8 weeks
The USS has nine quantitative questions, answered with a 6-point Likert scale, and rates satisfaction, ease of use, and adequacy of training. The USS also contains an open-ended question where participants can provide any additional comments. Both groups will complete this.
Acceptability- Computer System Usability Questionnaire (CSUQ) scores
Time frame: 8 weeks
The CSUQ has 19 questions, answered using a 7-point Likert scale, to rate overall satisfaction, usefulness, information quality and interface quality. Both groups will complete this.
Acceptability- PortionSize Ed app usage data
Time frame: 8 weeks
PortionSize Ed app usage data including number of meals logged and number of times the app was used. Only the HI-FLY + PSEd group will complete this.
Acceptability- Reason for study drop out
Time frame: 8 weeks
Participant reports reason for study drop out.
Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score
Time frame: 8 weeks
Change in total HEI-2020 score for each study arm. Ranges from 0 to 100 with 100 being the highest score.
Efficacy- Change in HEI-2020 component scores
Time frame: 8 weeks
Change in HEI-2020 component scores for each study arm. There are 13 component scores which are summed to give the total HEI-2020 score of 100.
Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey
Time frame: 8 weeks
Change in healthy eating behavior scores between baseline and the final visit for both study arms.
Feasibility- Study Attrition
Time frame: 8 weeks
No more than 15% study attrition.
1 secondary outcome
Change in body weight
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Yes. The PI, Dr. Lozano, is committed to sharing de-identified data with other researchers. The PI will share data with other investigators and/or potential collaborators even during the life of an ongoing grant and before the primary paper generated from grant work is accepted for publication from the project, though would ask for secondary papers to be submitted after a grant's main paper is accepted for publication. Also, as required by an increasing number of journals, the PI will fully comply with data posting guidelines for accepted papers that require the submission of de-identified data to a repository once the paper is accepted where those data can be downloaded by the general public. The PI is committed to sharing data generated by this grant with as few limitations as possible within compliance rules.
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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.
Chloe P Lozano, PhD principal investigator
University of Hawaii at Manoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HI-FLY Curriculum and HI-FLY Curriculum + PortionSize Ed app in people with Diet, Healthy, run by University of Hawaii 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloe P Lozano, PhD ((808) 956-7095, cpanizza@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Study enrollment (time frame: 8 weeks). The study lists 9 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 12 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.