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

NCT07732569 | Not Yet Recruiting

• 1 other identifier: STUDY2026-0908
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eating Behavior Changes

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

Outcome Measures

Primary Outcomes (3)

• Intervention Feasibility

  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

  Usability of the LLHS digital intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ evaluates participant perceptions of app usability, including ease of use, interface and satisfaction, and usefulness. Higher scores indicate greater perceived usability.

  End of the intervention (8 weeks)

• Intervention Acceptability

  Acceptability of the LLHS digital intervention will be assessed using the Acceptability of Intervention Measure (AIM). The AIM evaluates participant perceptions of whether the intervention is appealing, appropriate, and satisfactory. Higher scores indicate greater perceived acceptability.

  End of the intervention (8 weeks)

Secondary Outcomes (9)

• Behavioral Capability for Healthy Eating

  Baseline and end of intervention, approximately 8 weeks

• Self-Efficacy for Healthy Eating

  Baseline and end of intervention, approximately 8 weeks

• Outcome Expectations for Healthy Eating

  Baseline and end of intervention, approximately 8 weeks

• Dietary Quality

  Baseline and end of intervention, approximately 8 weeks

• Nutrition Literacy

  Baseline and end of intervention (approximately 8 weeks)

Other Outcomes (1)

• Skin Carotenoid Score

  Baseline and end of intervention, approximately 8 weeks

Study Arms (2)

LLHS Digital Intervention

EXPERIMENTAL

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 Toolkit

ACTIVE 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

Interventions

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.

Also known as: LLHS, LLHS Digital Intervention

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.

Also known as: Digital Nutrition Toolkit, Static Nutrition Toolkit

Static Digital Nutrition Toolkit

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Texas A&M University: lead

Related Publications (4)

• 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.

  PMID: 18719665 BACKGROUND

• 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.

  PMID: 27777223 BACKGROUND

• 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.

  PMID: 35742477 BACKGROUND

• 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.

  PMID: 35766027 BACKGROUND

Central Study Contacts

Hyunjung Lee, PhD

CONTACT

979-321-7084; grace.lee@ag.tamu.edu

Chinanu Gubor, MS

CONTACT

cggubor@tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share