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NCT Number: NCT07732569

Live Long, Heart Strong: A Digital Nutrition Intervention for 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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Live Long, Heart Strong (LLHS) Digital Nutrition Intervention

Behavioral

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.

Other names: LLHS, LLHS Digital Intervention

Static Digital Nutrition Education Toolkit

Behavioral

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.

Other names: Digital Nutrition Toolkit, Static Nutrition Toolkit

Primary outcomes

  1. Intervention Feasibility

    Time frame: Baseline through end of the intervention (8 weeks)

    Feasibility of the LLHS intervention, assessed by participant retention, intervention completion, and adherence throughout the study.

  2. Intervention Usability

    Time frame: 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.

  3. Intervention Acceptability

    Time frame: 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.

Secondary outcomes

  1. Self-Efficacy for Healthy Eating

    Time frame: 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.

  2. Dietary Quality

    Time frame: 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.

  3. Nutrition Literacy

    Time frame: 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.

  4. Self-Regulation for Healthy Eating

    Time frame: 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.

  5. Body Mass Index

    Time frame: Baseline and end of intervention (~8 weeks)

    Body mass index (kg/m²) calculated from measured height and weight collected during in-person study visits.

  6. Waist Circumference

    Time frame: 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.

  7. Resting Blood Pressure

    Time frame: Baseline and end of intervention

    Resting systolic and diastolic blood pressure measured using a validated automated blood pressure monitor.

Other outcomes

  1. Skin Carotenoid Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chinanu Gubor, MS

CONTACT

[email protected]

Hyunjung Lee, PhD

CONTACT

[email protected]

979-321-7084

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Acronym: LLHS

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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