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HI-FLY integrated with the PortionSize Ed app (HI-FLY + PSEd). for Healthy Eating

N/A
Recruiting
Led By Chloe P Lozano, PhD
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial aims to see if using the PortionSize Ed mobile app can help early adolescents in the HI-FLY program in Hawaii improve their eating habits over 8 weeks. Participants will be split

Who is the study for?
This trial is for early adolescents in Hawaii who are part of the HI-FLY program aimed at promoting healthy eating. Participants will be using a mobile app to track and improve their diet. There's no mention of specific inclusion or exclusion criteria, so it seems open to those already enrolled in HI-FLY.Check my eligibility
What is being tested?
The study is testing if adding the PortionSize Ed app to the standard HI-FLY curriculum helps kids eat better. Half will use just the curriculum (HI-FLY), and half will get both (HI-FLY + PSEd). They'll compare results after 8 weeks to see if there's any difference.See study design
What are the potential side effects?
Since this trial involves educational programs and a dietary tracking app, there aren't typical medical side effects. However, participants may experience increased awareness about their eating habits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability- Computer System Usability Questionnaire (CSUQ) scores
Acceptability- PortionSize Ed app usage data
Acceptability- Reason for study drop out
+6 more
Secondary outcome measures
Change in body weight

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HI-FLY integrated with the PortionSize Ed app (HI-FLY + PSEd).Experimental Treatment1 Intervention
Participants will receive HI-FLY usual care and be provided with the PortionSize Ed mobile app for the entire study.
Group II: usual HI-FLY curriculum (HI-FLY)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

United States Department of Agriculture (USDA)FED
97 Previous Clinical Trials
350,702 Total Patients Enrolled
University of HawaiiLead Sponsor
115 Previous Clinical Trials
54,629 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
305 Previous Clinical Trials
181,976 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to enroll as a participant in this clinical trial?

"Individuals aged between 11 and 14 years who adhere to a balanced diet are eligible for participation in this study. The aim is to enroll approximately 60 participants."

Answered by AI

Is this clinical trial currently open for enrollment?

"Yes, information available on clinicaltrials.gov indicates that recruitment is ongoing for this study. The trial was first listed on 4/23/2024 and last updated on 4/8/2024. It aims to enroll 60 participants from a single site."

Answered by AI

What is the current number of individuals being recruited to participate in this clinical trial?

"Affirmative, data on clinicaltrials.gov confirms the ongoing recruitment for this study. Originally listed on April 23rd, 2024 and most recently updated on April 8th, 2024, the trial aims to enlist a total of 60 participants from one designated site."

Answered by AI

Is the trial accepting individuals aged 60 and above?

"Individuals aged between 11 and 14 years are eligible for participation in this clinical trial."

Answered by AI
~40 spots leftby Oct 2024