Live Long, Heart Strong: A Digital Nutrition Intervention for Emerging Adults | NCT07732569

NCT07732569

Overview

NCT ID: NCT07732569
Lead Sponsor: Texas A&M UniversityOTHER
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
Brief 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). 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jan 2027Estimated
Primary Completion Date: May 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Hyunjung Lee, PhDContact
grace.lee@ag.tamu.edu979-321-7084

Similar Studies

Participant Group/Arms

LLHS Digital InterventionExperimental

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.

Behavioral: Live Long, Heart Strong (LLHS) Digital Nutrition Intervention

Static Digital Nutrition ToolkitActive Comparator

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.

Behavioral: Static Digital Nutrition Education Toolkit