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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06360367
Other study ID # 2023-00060
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 23, 2024
Est. completion date October 22, 2024

Study information

Verified date April 2024
Source University of Hawaii
Contact Chloe P Lozano, PhD
Phone (808) 956-7095
Email cpanizza@hawaii.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 22, 2024
Est. primary completion date October 22, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility Inclusion Criteria: - Males or females - Grades 6 to 8 students - Attend the target school on Kauai, Hawaii Exclusion Criteria: - No additional exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Hawaii at Manoa Honolulu Hawaii

Sponsors (3)

Lead Sponsor Collaborator
University of Hawaii Pennington Biomedical Research Center, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility- Study enrollment At least 65% of students in each classroom enroll in the study. 8 weeks
Primary 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
Primary 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
Primary 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
Primary Acceptability- Reason for study drop out Participant reports reason for study drop out. 8 weeks
Primary 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
Primary 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
Primary 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
Primary Feasibility- Study Attrition No more than 15% study attrition. 8 weeks
Secondary Change in body weight Mean change in body weight between the baseline and final study visit. 8 weeks
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