mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedStudy Start
First participant enrolled
April 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2024
CompletedApril 12, 2024
April 1, 2024
6 months
April 8, 2024
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (1)
Change in body weight
8 weeks
Study Arms (2)
usual HI-FLY curriculum (HI-FLY)
ACTIVE COMPARATORThe 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).
EXPERIMENTALParticipants will receive HI-FLY usual care and be provided with the PortionSize Ed mobile app for the entire study.
Interventions
Participants receive the standard HI-FLY Curriculum over 6 weeks.
Participants receive the standard HI-FLY Curriculum over 6 weeks and the PortionSize Ed mobile app.
Eligibility Criteria
You may qualify if:
- Males or females
- Grades 6 to 8 students
- Attend the target school on Kauai, Hawaii
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Hawaiilead
- United States Department of Agriculture (USDA)collaborator
- Pennington Biomedical Research Centercollaborator
Study Sites (1)
University of Hawaii at Manoa
Honolulu, Hawaii, 96822, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Chloe P Lozano, PhD
University of Hawaii at Manoa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Research Fellow
Study Record Dates
First Submitted
April 8, 2024
First Posted
April 11, 2024
Study Start
April 23, 2024
Primary Completion
October 22, 2024
Study Completion
October 22, 2024
Last Updated
April 12, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- Access to all data will be controlled by the PI, Dr. Lozano.
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.