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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Live Long, Heart Strong (LLHS) Digital Nutrition 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-infor
• Поведенческое Static Digital Nutrition Education 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.

Первичные конечные точки

• Intervention Feasibility [Срок оценки: Baseline through end of the intervention (8 weeks)]
• Intervention Usability [Срок оценки: End of the intervention (8 weeks)]
• Intervention Acceptability [Срок оценки: End of the intervention (8 weeks)]

Вторичные конечные точки (7)

• Self-Efficacy for Healthy Eating [Срок оценки: Baseline and end of intervention, approximately 8 weeks]
• Dietary Quality [Срок оценки: Baseline and end of intervention, approximately 8 weeks]
• Nutrition Literacy [Срок оценки: Baseline and end of intervention (approximately 8 weeks)]
• Self-Regulation for Healthy Eating [Срок оценки: Baseline and end of intervention (approximately 8 weeks)]
• Body Mass Index [Срок оценки: Baseline and end of intervention (~8 weeks)]
• Waist Circumference [Срок оценки: Baseline and end of intervention (~8 weeks)]
• Resting Blood Pressure [Срок оценки: Baseline and end of intervention]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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.000000000000 PMID 35766027

Идентификаторы

NCT: NCT07732569 · STUDY2026-0908

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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