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

NCT ID: NCT06360367

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2024-10-22

Brief 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.

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:

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.

Conditions

Diet, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

HI-FLY Curriculum

Intervention Type: BEHAVIORAL

Participants receive the standard HI-FLY Curriculum over 6 weeks.

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.

Group Type: EXPERIMENTAL

HI-FLY Curriculum + PortionSize Ed app

Intervention Type: BEHAVIORAL

Participants receive the standard HI-FLY Curriculum over 6 weeks and the PortionSize Ed mobile app.

Interventions

HI-FLY Curriculum

Participants receive the standard HI-FLY Curriculum over 6 weeks.

Intervention Type: BEHAVIORAL

HI-FLY Curriculum + PortionSize Ed app

Participants receive the standard HI-FLY Curriculum over 6 weeks and the PortionSize Ed mobile app.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Chloe Lozano

Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chloe P Lozano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii at Manoa

Locations

University of Hawaii at Manoa

Honolulu, Hawaii, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chloe P Lozano, PhD

Role: CONTACT

cpanizza@hawaii.edu

(808) 956-7095

Rachel Novotny, PhD

Role: CONTACT

novotny@hawaii.edu

(808) 956-7095

Facility Contacts

Chloe P Lozano, PhD

Role: primary

cpanizza@hawaii.edu

808-956-7095

Other Identifiers

2023-00060

Identifier Type: -

Identifier Source: org_study_id