mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii

April 10, 2024 updated by: Chloe Lozano, University of Hawaii

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Assess the feasibility, and acceptability of integrating PortionSize Ed into HI-FLY among Grades 6 to 8 students on Kauai, Hawaii.
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96822
        • Recruiting
        • University of Hawaii At Manoa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males or females
  • Grades 6 to 8 students
  • Attend the target school on Kauai, Hawaii

Exclusion Criteria:

  • No additional exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: usual HI-FLY curriculum (HI-FLY)
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.
Behavioral: HI-FLY Curriculum
Participants receive the standard HI-FLY Curriculum over 6 weeks.
Experimental: HI-FLY integrated with the PortionSize Ed app (HI-FLY + PSEd).
Participants will receive HI-FLY usual care and be provided with the PortionSize Ed mobile app for the entire study.
Behavioral: HI-FLY Curriculum + PortionSize Ed app
Participants receive the standard HI-FLY Curriculum over 6 weeks and the PortionSize Ed mobile app.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility- Study enrollment
Time Frame: 8 weeks
At least 65% of students in each classroom enroll in the study.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
Acceptability- Reason for study drop out
Time Frame: 8 weeks
Participant reports reason for study drop out.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
Feasibility- Study Attrition
Time Frame: 8 weeks
No more than 15% study attrition.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: 8 weeks
Mean change in body weight between the baseline and final study visit.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Hawaii

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pennington Biomedical Research Center
United States Department of Agriculture (USDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chloe P Lozano, PhD, University of Hawaii At Manoa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-00060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

Access to all data will be controlled by the PI, Dr. Lozano.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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