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Eating Behavior ChangesLLHSNCT07732569

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

A study testing Live Long, Heart Strong (LLHS) Digital Nutrition Intervention and Static Digital Nutrition Education Toolkit in people with Eating Behavior Changes, run by Texas A&M University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Eating Behavior Changes
What is being tested?
Live Long, Heart Strong (LLHS) Digital Nutrition Intervention and Static Digital Nutrition Education Toolkit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jan 2027to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hyunjung Lee, PhD contact

979-321-7084

grace.lee@ag.tamu.edu

Chinanu Gubor, MS contact

cggubor@tamu.edu

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Live Long, Heart Strong (LLHS) Digital Nutrition Intervention, Static Digital Nutrition Education Toolkit
Keywords
Nutrition, Healthy Eating, Cardiovascular Disease Prevention, Emerging Adults, Young Adults, Digital Health, Mobile Health (mHealth), Nutrition Education, Behavioral Intervention, Health Promotion, Social Cognitive Theory, Human-Centered Design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Live Long, Heart Strong (LLHS) Digital Nutrition InterventionBehavioural

    Also called LLHS, LLHS Digital Intervention

    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.

  • Static Digital Nutrition Education ToolkitBehavioural

    Also called Digital Nutrition Toolkit, Static Nutrition Toolkit

    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.

Study groups in NCT07732569
Study groupRoleWhat they receive
LLHS Digital InterventionExperimentalParticipants 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.
Receives: Behavioral: Live Long, Heart Strong (LLHS) Digital Nutrition Intervention
Static Digital Nutrition ToolkitActive comparatorParticipants 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.
Receives: Behavioral: Static Digital Nutrition Education Toolkit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention Feasibility

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

    Measured: Baseline through end of the intervention (8 weeks)

  2. Intervention Usability

    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.

    Measured: End of the intervention (8 weeks)

  3. Intervention Acceptability

    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.

    Measured: End of the intervention (8 weeks)

Secondary outcomes (7)
  1. Self-Efficacy for Healthy Eating

    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.

    Measured: Baseline and end of intervention, approximately 8 weeks

  2. Dietary Quality

    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.

    Measured: Baseline and end of intervention, approximately 8 weeks

  3. Nutrition Literacy

    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.

    Measured: Baseline and end of intervention (approximately 8 weeks)

  4. Self-Regulation for Healthy Eating

    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.

    Measured: Baseline and end of intervention (approximately 8 weeks)

  5. Body Mass Index

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

    Measured: Baseline and end of intervention (~8 weeks)

  6. Waist Circumference

    Waist circumference measured using standardized anthropometric procedures to provide a preliminary indicator of central adiposity and cardiometabolic risk.

    Measured: Baseline and end of intervention (~8 weeks)

  7. Resting Blood Pressure

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

    Measured: Baseline and end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732569
Sponsor's protocol ID
STUDY2026-0908
Acronym
LLHS
Status last verified
Aug 2026
First submitted
23 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Nelson MC, Story M, Larson NI, Neumark-Sztainer D, Lytle LA. Emerging adulthood and college-aged youth: an overlooked age for weight-related behavior change. Obesity (Silver Spring). 2008 Oct;16(10):2205-11. doi: 10.1038/oby.2008.365. No abstract available.

    PubMed 18719665
  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

    PubMed 27777223
  • Al-Nawaiseh HK, McIntosh WA, McKyer LJ. An-m-Health Intervention Using Smartphone App to Improve Physical Activity in College Students: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jun 13;19(12):7228. doi: 10.3390/ijerph19127228.

    PubMed 35742477
  • Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.

    PubMed 35766027

Questions about this trial

What is this clinical trial studying?

A study testing Live Long, Heart Strong (LLHS) Digital Nutrition Intervention and Static Digital Nutrition Education Toolkit in people with Eating Behavior Changes, run by Texas A&M University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hyunjung Lee, PhD (979-321-7084, grace.lee@ag.tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Feasibility (time frame: Baseline through end of the intervention (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732569, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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