mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in 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: Recruiting
• Conditions: Diet, Healthy
• Intervention / Treatment: Behavioral: HI-FLY Curriculum; Behavioral: HI-FLY Curriculum + PortionSize Ed app

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloe P Lozano, PhD; Phone Number: (808) 956-7095; Email: cpanizza@hawaii.edu
• Study Contact Backup: Name: Rachel Novotny, PhD; Phone Number: (808) 956-7095; Email: novotny@hawaii.edu

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96822
      • Recruiting
      • University of Hawaii at Manoa
      • Contact: Chloe P Lozano, PhD; Phone Number: 808-956-7095; Email: cpanizza@hawaii.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Feasibility- Study enrollment	At least 65% of students in each classroom enroll in the study.	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.	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.	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.	8 weeks
Acceptability- Reason for study drop out	Participant reports reason for study drop out.	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.	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.	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.	8 weeks
Feasibility- Study Attrition	No more than 15% study attrition.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Mean change in body weight between the baseline and final study visit.	8 weeks

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: Pennington Biomedical Research Center; United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Chloe P Lozano, PhD, University of Hawaii at Manoa

Study record dates

Study Major Dates

• Study Start (Estimated): April 23, 2024
• Primary Completion (Estimated): October 22, 2024
• Study Completion (Estimated): October 22, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: diet quality, HEI-2020 scores
• Other Study ID 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