Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360367
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-08
Brief Title:
mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
Sponsor:
University of Hawaii
Organization:
University of Hawaii
Study Overview
Official Title:
mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Hawaii-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
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 users 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 eg apple raw and select a portion size from a drop-down menu eg 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 eg 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 Hawaii-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
The food group recommendations in PortionSize Ed are tailored based on the users 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 eg apple raw and select a portion size from a drop-down menu eg 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 eg 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 Hawaii-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None