Live Long, Heart Strong: A Digital Nutrition Intervention for Emerging Adults
ConditionEating Behavior Changes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorTexas A&M University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Live Long, Heart Strong (LLHS) Digital Nutrition Intervention
BehavioralThe 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 Toolkit
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: LLHS Digital InterventionExperimental treatment 1 intervention
Group B: Static Digital Nutrition ToolkitActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intervention Feasibility
Feasibility of the LLHS intervention, assessed by participant retention, intervention completion, and adherence throughout the study.
Time frame
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.
Time frame
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.
Time frame
End of the intervention (8 weeks)Secondary outcomes
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.
Time frame
Baseline and end of intervention, approximately 8 weeks2
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.
Time frame
Baseline and end of intervention, approximately 8 weeks3
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.
Time frame
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.
Time frame
Baseline and end of intervention (approximately 8 weeks)Other outcomes
1
Skin Carotenoid Score
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.
Time frame
Baseline and end of intervention, approximately 8 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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