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临床试验/NCT06360367
NCT06360367Unknown不适用

mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii

University of Hawaii2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Acceptability- Reason for study drop out

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • No additional exclusion criteria

结局指标

主要结局

Acceptability- Reason for study drop out

时间窗: 8 weeks

Participant reports reason for study drop out.

Efficacy- Change in HEI-2020 component scores

时间窗: 8 weeks

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.

Feasibility- Study Attrition

时间窗: 8 weeks

No more than 15% study attrition.

Acceptability- PortionSize Ed app usage data

时间窗: 8 weeks

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.

Feasibility- Study enrollment

时间窗: 8 weeks

At least 65% of students in each classroom enroll in the study.

Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score

时间窗: 8 weeks

Change in total HEI-2020 score for each study arm. Ranges from 0 to 100 with 100 being the highest score.

Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey

时间窗: 8 weeks

Change in healthy eating behavior scores between baseline and the final visit for both study arms.

Acceptability- User Satisfaction Survey (USS) scores and qualitative responses

时间窗: 8 weeks

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.

Acceptability- Computer System Usability Questionnaire (CSUQ) scores

时间窗: 8 weeks

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.

次要结局

  • Change in body weight(8 weeks)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chloe Lozano

Postdoctoral Research Fellow

University of Hawaii

研究点 (2)

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