Clinical trial NCT06360367: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
Official title: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Healthy
Keywords: diet quality, HEI-2020 scores
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: Pennington Biomedical Research Center
First posted: 2024-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No additional exclusion criteria

Primary outcomes:
measure: Feasibility- Study enrollment
timeFrame: 8 weeks
measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses
timeFrame: 8 weeks
measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores
timeFrame: 8 weeks
measure: Acceptability- PortionSize Ed app usage data
timeFrame: 8 weeks
measure: Acceptability- Reason for study drop out
timeFrame: 8 weeks
measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score
timeFrame: 8 weeks
measure: Efficacy- Change in HEI-2020 component scores
timeFrame: 8 weeks
measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey
timeFrame: 8 weeks
measure: Feasibility- Study Attrition
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii at Manoa
state: Hawaii
Study officials:
affiliation: University of Hawaii at Manoa
name: Chloe P Lozano, PhD
role: PRINCIPAL_INVESTIGATOR
References: