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临床试验/NCT03762135
NCT03762135已完成不适用

Location Initiated Individualized Texts for Adolescent Health (LIITAH)

University of Michigan2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
2
主要终点
Visits to Restaurants

研究概览

简要总结

The goal of this study is to test whether the mobile application (app.) helps adolescents make healthy food choices, decreasing calories purchased from restaurants, fewer number of visits to restaurants, and if it has an impact on their body mass index (BMI). Eligible adolescents will be enrolled in the study along with a parent for approximately 6 weeks.

详细描述

Excess weight puts millions of adolescents in the US at risk for weight-related illnesses and premature death and disproportionately impacts Black and Hispanic populations. Black and Hispanic youth are more likely to be exposed to communities with high densities of fast-food restaurants. This project sought to help adolescents make healthy choices in obesogenic settings that are relevant to and have been tested in populations who are at the highest risk for obesity and its associated costs.

Previous research revealed that adolescents welcomed health-related text messages (based on Self Determination Theory and Motivational Interviewing) if they viewed them as personally relevant and if they were received at times when they faced dietary choices. Based on these findings, the following is hypothesized: delivering messages (tailored to users' preferences and values) at a time and place when they are making a dietary choice (e.g., in a restaurant) will positively influence their choices.

Thus, the Health Kick+ App was developed, and it aimed to deliver tailored messages at the point of purchase. This app identifies when users are in a restaurant, automatically sends culturally relevant messages tailored to user preferences and the menu options at their location with the aim of prompting users to make a healthy choice, and allows users to submit an annotated photo response about their food choice. Participants were recruited as parent/guardian and teen dyads. Teen participants also were allowed to set goals, see progress reports, and receive daily health tips. Parent/guardian participants could communicate with the teen via the app and monitor progress.

This project worked towards enhancing the earlier version of the app developed in the LIITA3H study. The LIITAH study worked towards developing 1) deeper individual tailoring, making the content even more relevant to users from different races/ethnicities; 2) a dyad capability for parents to use the app coordinated with their adolescent; and 3) additional engagement features to remind participants to use the app frequently.

As of 2020, due to the influence of the public health emergency, lockdowns prevented any participants from engaging in going to restaurants as they previously would have. Due to the trial beginning in 2021, no six-month app-based data was acquired before the lockdown, and research limitations were imposed. When behavioral research of this type was allowed to resume, limited time remained before the funded study would have to end. Thus, certain aspects of the protocol and intervention were modified. To be pragmatic under these constrained circumstances, the intervention was shortened from 6 months to 6 weeks.

研究设计

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

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • eat restaurant food at least 3 times a week and have a parent who agrees to participate.

排除标准

  • 未提供

结局指标

主要结局

Visits to Restaurants

时间窗: over 6 weeks

Number of visits will be obtained from the app. This outcome measure is based exclusively on adolescent data.

Calories Purchased From Restaurants

时间窗: over 6 weeks

Number of calories purchased by the adolescent and for the adolescent were assessed using annotated photos, and nutritional data from the restaurant menus. This analysis used population averaged generalized estimating equation regressions (GEE) to compare trajectories of calories purchased between groups. The GEE approach allowed for the correlation in repeated observations collected from participants over time. This outcome measure is based exclusively on adolescent data.

次要结局

  • Body Mass Index (BMI) Percentile(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan J Woolford, MD, MPH

Assistant Professor

University of Michigan

研究点 (2)

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