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Live Long, Heart Strong: A Digital Nutrition Intervention for Emerging Adults (LLHS)

2026年8月3日 更新者:Hyunjung Lee、Texas A&M University

A Pilot Randomized Controlled Trial of the Digital Twin-Supported Live Long, Heart Strong Digital Nutrition Intervention to Promote Cardiovascular Health Behaviors Among Emerging Adults

Live Long, Heart Strong (LLHS) is a theory-guided, digital twin-supported nutrition intervention designed to promote cardiovascular health behaviors among emerging adults (18-25 years). Developed using a human-centered design approach and informed by Social Cognitive Theory, the intervention incorporates personalized nutrition education, interactive learning activities, goal setting, self-monitoring, quizzes, youth-informed educational videos, tailored feedback, reminders, and gamification to support healthy eating behaviors and improve dietary quality.

In this pilot randomized controlled trial, participants will be randomly assigned to either the LLHS intervention or an active comparator consisting of a static, non-personalized digital nutrition education toolkit containing similar evidence-based educational content without personalization, interactivity, or behavioral support features. The study will evaluate implementation outcomes (feasibility, usability, acceptability, and appropriateness), changes in psychosocial and behavioral outcomes related to healthy eating, and preliminary cardiovascular-related health indicators. Findings will inform continued refinement of the LLHS intervention and the design of a future fully powered efficacy trial.

研究概览

详细说明

Cardiovascular disease (CVD) remains the leading cause of death in the United States, and many modifiable risk factors begin to develop during emerging adulthood. This developmental period represents an important opportunity to establish lifelong dietary habits and other health-promoting behaviors that support long-term cardiovascular health. However, emerging adults often encounter barriers to healthy eating, including limited nutrition knowledge and food preparation skills, financial constraints, time pressures, and increasing independence in food-related decision making. Existing nutrition interventions frequently do not address these developmental and contextual challenges or sustain long-term engagement.

The Live Long, Heart Strong (LLHS) intervention was developed to address these gaps through a theory-guided digital nutrition intervention specifically designed for emerging adults. Intervention development follows a human-centered design approach, incorporating iterative input from emerging adults throughout the design and refinement process to improve the relevance, usability, and acceptability of intervention content and features. The intervention is informed by Social Cognitive Theory and incorporates evidence-based behavior change methods designed to strengthen behavioral capability, self-efficacy, outcome expectations, and self-regulation, with the goal of improving dietary behaviors that support long-term cardiovascular health.

Participants will be randomly assigned to one of two study arms. The experimental group will receive access to the LLHS digital intervention, which includes personalized nutrition education, interactive learning activities, goal setting, self-monitoring, quizzes, youth-informed educational videos, tailored feedback, reminders, gamification, and digital twin-supported personalized guidance. The active comparator group will receive access to a static, non-personalized digital nutrition education toolkit containing similar evidence-based educational information presented without personalization, tailoring, interactivity, or behavioral support features.

The primary objectives of this pilot randomized controlled trial are to evaluate the feasibility, usability, acceptability, and preliminary effectiveness of the LLHS intervention relative to the active comparator. Primary outcomes include implementation outcomes (usability, acceptability, appropriateness, and feasibility). Secondary outcomes include changes in Social Cognitive Theory constructs, nutrition literacy, and dietary quality assessed using the Healthy Eating Index. In addition, participants will complete in-person baseline and post-intervention assessments of skin carotenoid levels using the VeggieMeter and other anthropometric and cardiovascular-related health indicators (e.g., body mass index, waist circumference, and resting blood pressure) to evaluate the feasibility of these measurements and explore preliminary intervention-related changes. Participant demographic and socioeconomic characteristics, including measures such as food security, financial status, living conditions, and other relevant characteristics, will also be collected to characterize the target population and inform interpretation of intervention effects. Findings from this pilot trial will inform continued refinement of the LLHS intervention, establish the feasibility of study procedures and outcome assessments, and provide preliminary evidence to support a future fully powered efficacy trial.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Participants are eligible if they:

  • Are 18 to 25 years old.
  • Are able to read and understand English.
  • Reside in Texas at the time of the study.
  • Own a smartphone with internet access.
  • Are willing to be randomized to either study group, attend baseline and post-intervention study visits, and complete study assessments.
  • Provide informed consent.

Participants are excluded if they:

  • Are younger than 18 years or older than 25 years.
  • Are unable to read or understand English.
  • Do not have reliable access to a smartphone with internet access.
  • Are unable or unwilling to provide informed consent.
  • Are currently participating in another nutrition, weight management, or cardiovascular health intervention study that could affect study outcomes.
  • Have a medical condition or dietary restriction that requires a highly specialized diet and would make the general LLHS nutrition content inappropriate without clinical supervision.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:LLHS Digital Intervention
Participants assigned to this arm will receive access to the Live Long, Heart Strong (LLHS) digital nutrition intervention. The intervention was developed using a human-centered design approach and is informed by Social Cognitive Theory. It includes personalized nutrition education, interactive learning activities, quizzes, goal setting, self-monitoring, tailored feedback, reminders, gamification, and youth-informed educational content designed to promote healthy eating behaviors for cardiovascular disease prevention among emerging adults.
The Live Long, Heart Strong (LLHS) Digital Nutrition Intervention is a theory-guided behavioral intervention developed using a human-centered design approach and informed by Social Cognitive Theory. The intervention is designed to promote healthy eating behaviors for cardiovascular disease prevention among emerging adults through a personalized digital platform. Participants receive tailored nutrition education, interactive learning activities, goal setting, self-monitoring, quizzes, youth-informed educational videos, tailored feedback, reminders, and gamification. Intervention content focuses on developing knowledge, behavioral capability, self-efficacy, observational learning, outcome expectations, and self-regulation to support sustainable dietary behavior change.
其他名称:
  • LLHS
  • LLHS Digital Intervention
有源比较器:Static Digital Nutrition Toolkit
Participants assigned to this arm will receive access to a static, non-personalized digital nutrition education toolkit containing evidence-based information related to healthy eating and cardiovascular disease prevention. The toolkit provides educational content comparable in topic to the experimental intervention but does not include personalization, interactive activities, tailored feedback, goal setting, self-monitoring, reminders, or gamification. The active comparator was selected to control for exposure to evidence-based digital nutrition education while allowing evaluation of the added effects of the personalized, interactive, and Social Cognitive Theory-informed behavior change components incorporated into LLHS.
The Static Digital Nutrition Education Toolkit is an active comparator consisting of evidence-based digital educational materials related to healthy eating and cardiovascular disease prevention. Participants receive the same general educational topics as the experimental group through a static, non-personalized digital format. The toolkit does not include interactive activities, personalization, tailored feedback, goal setting, self-monitoring, reminders, or gamification.
其他名称:
  • Digital Nutrition Toolkit
  • Static Nutrition Toolkit

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Intervention Feasibility
大体时间:Baseline through end of the intervention (8 weeks)
Feasibility of the LLHS intervention, assessed by participant retention, intervention completion, and adherence throughout the study.
Baseline through end of the intervention (8 weeks)
Intervention Usability
大体时间:End of the intervention (8 weeks)
Usability of the LLHS digital intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ is a 21-item instrument with scores ranging from 1 to 7, where higher scores indicate greater perceived usability of the mobile health application.
End of the intervention (8 weeks)
Intervention Acceptability
大体时间:End of the intervention (8 weeks)
Acceptability of the LLHS digital intervention will be assessed using the Acceptability of Intervention Measure (AIM). The AIM is a 4-item instrument with scores ranging from 1 to 5, where higher scores indicate greater perceived acceptability of the intervention.
End of the intervention (8 weeks)

次要结果测量

结果测量
措施说明
大体时间
Body Mass Index
大体时间:Baseline and end of intervention (~8 weeks)
Body mass index (kg/m²) calculated from measured height and weight collected during in-person study visits.
Baseline and end of intervention (~8 weeks)
Waist Circumference
大体时间:Baseline and end of intervention (~8 weeks)
Waist circumference measured using standardized anthropometric procedures to provide a preliminary indicator of central adiposity and cardiometabolic risk.
Baseline and end of intervention (~8 weeks)
Resting Blood Pressure
大体时间:Baseline and end of intervention
Resting systolic and diastolic blood pressure measured using a validated automated blood pressure monitor.
Baseline and end of intervention
Self-Efficacy for Healthy Eating
大体时间:Baseline and end of intervention, approximately 8 weeks
Healthy eating self-efficacy will be assessed using the 7-item Healthy Eating subscale of the Healthy Eating and Weight Self-Efficacy (HEWSE) Scale. Scores range from 1 to 5, with higher scores indicating greater confidence in one's ability to make and maintain healthy eating behaviors.
Baseline and end of intervention, approximately 8 weeks
Dietary Quality
大体时间:Baseline and end of intervention, approximately 8 weeks
Dietary quality will be assessed using the Healthy Eating Index-2020 (HEI-2020) calculated from dietary recall data. HEI-2020 scores range from 0 to 100, with higher scores indicating greater adherence to the Dietary Guidelines for Americans and higher overall dietary quality.
Baseline and end of intervention, approximately 8 weeks
Nutrition Literacy
大体时间:Baseline and end of intervention (approximately 8 weeks)
Nutrition literacy will be assessed using the Young Adult Nutrition Literacy Tool (YA-NLT). Total scores range from 0 to 5, with higher scores indicating greater nutrition literacy.
Baseline and end of intervention (approximately 8 weeks)
Self-Regulation for Healthy Eating
大体时间:Baseline and end of intervention (approximately 8 weeks)
Self-regulation for healthy eating will be assessed using the Self-Regulation of Eating Behaviour Questionnaire (SREBQ). Total scores range from 1 to 5, with higher scores indicating greater self-regulation of eating behaviors.
Baseline and end of intervention (approximately 8 weeks)

其他结果措施

结果测量
措施说明
大体时间
Skin Carotenoid Score
大体时间:Baseline and end of intervention, approximately 8 weeks
Skin carotenoid levels will be assessed using the VeggieMeter as an exploratory biomarker of fruit and vegetable intake. Skin carotenoid scores range from 0 to 800, with higher scores indicating higher skin carotenoid concentrations and greater habitual fruit and vegetable intake.
Baseline and end of intervention, approximately 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be made publicly available because the dataset contains potentially identifiable information collected from a relatively small study population. De-identified aggregate results will be reported in scientific publications and presentations. Data sharing beyond published results may be considered on a case-by-case basis following publication, subject to institutional policies, ethical approval, and applicable data use agreements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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