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University of Georgia Mind Your Heart Pilot Study

22. června 2026 aktualizováno: Anita Reina, University of Georgia

The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are:

  1. Does participation in a 6-week nutrition education program improve dietary behaviors?
  2. Does participation in the program improve health measures such as blood lipids, blood pressure, and eye nutrient levels?

Participants will:

  1. Visit the Institute of Gerontology at the beginning and end of the 6-week study for:

    • Blood draws to measure blood lipids (e.g., cholesterol)
    • Blood pressure measurement
    • Eye exams to assess nutrient levels
    • Completion of questionnaires about dietary habits
  2. Complete online questionnaires before and after the study period
  3. Participate in the Mind Your Heart program by reviewing 6 online modules over 6 weeks (approximately 20-30 minutes per module)

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This study examines the efficacy of a 6-week, web-based nutrition education intervention (Mind Your Heart) on dietary behaviors and cardiometabolic health outcomes. The intervention is delivered via the University of Georgia e-Learning Commons (eLC) platform and incorporates evidence-based nutrition education and behavior change strategies.

Participants (UGA employees ≥18 years) are assigned to one of two virtual delivery approaches for the educational content. The intervention consists of six structured modules (approximately 20-30 minutes each), completed over a 6-week period.

Repeated measures are collected to assess behavioral and physiological change. Dietary behaviors and health habits are evaluated using validated self-report instruments administered via Qualtrics at baseline and post-intervention. To capture real-time eating behaviors, participants complete brief mobile-delivered questionnaires three times per week (two weekdays, one weekend day), totaling up to 18 assessments over the intervention period.

Objective health outcomes are assessed at baseline and follow-up laboratory visits and include cardiometabolic and nutritional biomarkers. Measures include venous blood sampling for lipid profiles, resting blood pressure, anthropometrics (height, weight, body composition), and ocular biomarkers (e.g., macular pigment optical density) as an index of nutrient status.

Dietary intake tracking is supported using a third-party application (MyFitnessPal), enabling complementary assessment of dietary patterns. Data are linked using unique study identifiers to ensure confidentiality. Integrated analyses will evaluate changes over time in behavioral and physiological outcomes and examine associations between intervention engagement, dietary behavior, and health indicators.

Typ studie

Intervenční

Zápis (Aktuální)

37

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Georgia
      • Athens, Georgia, Spojené státy, 30606
        • University of Georgia

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • Adults aged 18 years and older
  • Current University of Georgia (UGA) employees
  • Able to provide informed consent
  • Willing to complete online nutrition education modules over a 6-week period
  • Willing to attend in-person study visits for baseline and follow-up assessments
  • Willing to provide blood samples, blood pressure measurements, and complete eye exams
  • Willing to complete online and mobile-based questionnaires
  • Access to an internet-enabled device and a mobile phone for surveys and program

Exclusion Criteria:

  • Unable to complete study procedures, including online modules or in-person visits
  • Medical or other conditions that would preclude safe participation in study procedures (e.g., blood draw)
  • Lack of access to required technology (internet or mobile phone) for participation

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: DASH Diet with Mindful eating
Participants in this arm will receive the Mind Your Heart program delivered via the e-Learning Commons (eLC) platform, consisting of six asynchronous modules completed over 6 weeks (20-30 minutes each).In addition to standard nutrition education, this arm includes mindful eating training that emphasizes awareness of hunger and satiety cues, eating pace, emotional triggers, and sensory aspects of food. Content integrates mindfulness-based strategies to improve self-regulation and eating behaviors. Participants will track dietary intake using MyFitnessPal and complete brief, repeated surveys assessing eating behaviors. No additional non-dietary intervention components are provided.
Behaviorální: Mind Your Heart
The Mind Your Heart intervention is a 6-week web-based behavioral program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules integrating evidence-based DASH diet education with mindful eating training. Content focuses on awareness of hunger and satiety cues, sensory attention to food, and self-regulation of eating behaviors. Participants also complete dietary self-monitoring and ecological momentary assessment activities to support behavior change and reinforce program content.
Aktivní komparátor: DASH Diet education only
Participants in this arm will receive the Mind Your Heart nutrition education program delivered via the e-Learning Commons (eLC) platform. The intervention includes six asynchronous modules completed over 6 weeks (20-30 minutes each). Content emphasizes heart-healthy dietary patterns, including increasing fruit and vegetable intake, reducing saturated fat and added sugars, portion control, meal planning, and mindful eating. Behavior change techniques such as goal setting and self-monitoring are incorporated. Participants will track dietary intake using MyFitnessPal and complete brief surveys assessing eating behaviors throughout the intervention. No additional non-dietary intervention components are provided.
Behaviorální: DASH Diet Education
The DASH Diet Education intervention is a 6-week web-based nutrition education program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules focused on evidence-based DASH dietary recommendations and heart-healthy eating behaviors. Content includes dietary quality improvement, meal planning, portion control, label reading, and dietary self-monitoring to support behavior change.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in DASH Diet Score
Časové okno: Baseline to 6 weeks
Change in DASH diet adherence from baseline to 6 weeks was measured using the Dietary Approaches to Stop Hypertension (DASH) Diet Accordance Score. Dietary intake data were collected using MyFitnessPal and used to calculate adherence to nine DASH nutrient targets: total fat, saturated fat, protein, cholesterol, fiber, calcium, magnesium, sodium, and potassium. Each nutrient is scored as 0 (poor adherence), 0.5 (fair adherence), or 1 (compliant with the DASH target). Scores for all nine nutrients are summed to generate a total DASH Diet Accordance Score ranging from 0 to 9, with higher scores indicating greater adherence to DASH dietary recommendations and a more heart-healthy dietary pattern.
Baseline to 6 weeks
Change in Three Factor Eating Questionnaire
Časové okno: 6 weeks
Change in eating behaviors from baseline to 6 weeks was measured using the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18), an 18-item self-report instrument assessing three domains of eating behavior. Cognitive Restraint (6 items; mean score range 1-4) reflects the conscious restriction of food intake to control body weight or promote weight loss. Uncontrolled Eating (9 items; mean score range 1-4) reflects a tendency to overeat due to loss of control over food intake and responsiveness to hunger or food cues. Emotional Eating (3 items; mean score range 1-4) reflects the tendency to eat in response to negative emotions such as stress, anxiety, or sadness. Higher scores indicate greater levels of the respective eating behavior.
6 weeks
Changes in Mindful Eating Behaviors
Časové okno: 6 weeks
Change in mindful eating behaviors from baseline to 6 weeks was measured using the Mindful Eating Behavior Scale (MEBS), a 17-item self-report instrument assessing four domains of mindful eating. Focused Eating (5 items; mean score range 1-4) assesses attention to sensory aspects of food and the eating experience. Hunger and Satiety Cues (5 items; mean score range 1-4) assess awareness of and responsiveness to internal hunger and fullness signals. Eating with Awareness (3 items; mean score range 1-4) assesses conscious awareness of eating behaviors. Eating without Distraction (4 items; mean score range 1-4) assesses the ability to eat without engaging in competing activities or thoughts. Higher scores indicate greater mindful eating within each domain. A total MEBS score is not computed.
6 weeks
Changes in Motivation
Časové okno: 6 weeks
Change in motivation for regulating eating behaviors from baseline to 6 weeks was measured using the Regulation of Eating Behaviors Scale (REBS), a 24-item self-report measure based on Self-Determination Theory. The REBS assesses six types of motivation: Intrinsic Motivation, Integrated Regulation, Identified Regulation, Introjected Regulation, External Regulation, and Amotivation. Items are rated on a 7-point scale. Autonomous motivation is calculated by summing Intrinsic, Integrated, and Identified Regulation subscales; controlled motivation is calculated by summing Introjected, External Regulation, and Amotivation subscales. Both scores range from 12 to 84, with higher scores indicating stronger motivation in the respective category. A self-determination score is calculated from weighted subscale scores, with higher values indicating greater autonomous motivation to regulate eating behaviors.
6 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Blood Pressure
Časové okno: Baseline to 6 weeks
Change in resting systolic and diastolic blood pressure from baseline to 6 weeks was measured during in-person study visits using standardized clinical procedures. Blood pressure was recorded in millimeters of mercury (mmHg). Lower systolic and diastolic values indicate improved blood pressure control.
Baseline to 6 weeks
Change Body weight
Časové okno: Baseline to 6 weeks
Change in body weight from baseline to 6 weeks was measured using a calibrated digital scale. Weight was recorded in kilograms (kg). Lower values indicate weight loss.
Baseline to 6 weeks
Change in BMI
Časové okno: 6 weeks
Change in body mass index (BMI) from baseline to 6 weeks. BMI was calculated using the CDC Adult BMI Calculator based on measured height (cm) and weight (kg). BMI is reported in kg/m², with lower values indicating reduced body weight relative to height. Lower values indicate reductions in body weight relative to height.
6 weeks
Change in Waist Circumference
Časové okno: 6 weeks
Change in waist circumference from baseline to 6 weeks measured in centimeters (cm) using a standardized tape measure. Lower values indicate reduced central adiposity.
6 weeks
Change in Hip-to-Waist Ratio
Časové okno: 6 weeks
Change in waist-to-hip ratio from baseline to 6 weeks. Waist-to-hip ratio was calculated by dividing waist circumference (cm) by hip circumference (cm). Lower values indicate a more favorable body fat distribution and lower cardiometabolic risk.
6 weeks
Trait Mindfulness
Časové okno: 6 weeks
The Mindful Attention Awareness Scale (MAAS) was administered at baseline and used as a stratification variable for randomization, and was reassessed at 6 weeks to evaluate change in trait mindfulness. The MAAS is a 15-item self-report measure of present-moment attention and awareness. Items are rated on a 6-point scale ranging from 1 (almost always) to 6 (almost never). Total scores range from 15 to 90, with higher scores indicating greater trait mindfulness and present-moment awareness.
6 weeks
Change in Ocular Nutrient Status
Časové okno: Baseline to 6 weeks
Change in retinal carotenoid status from baseline to 6 weeks was measured as macular pigment optical density (MPOD) using customized heterochromatic flicker photometry with a Macular Metrics Densitometer (Macular Metrics, Rehoboth, MA, USA). MPOD reflects concentrations of the dietary carotenoids lutein, zeaxanthin, and meso-zeaxanthin in the retina. Participants adjusted the intensity of alternating blue (460 nm) and green (570 nm) light stimuli to minimize perceived flicker, and measurements were obtained at a retinal eccentricity of 30 minutes. MPOD is reported in optical density units, with higher values indicating greater retinal carotenoid status.
Baseline to 6 weeks
Changes in Perceived Stress
Časové okno: 6 weeks
Change in perceived stress from baseline to 6 weeks was measured using the Perceived Stress Scale-10 (PSS-10), a 10-item self-report measure assessing the degree to which individuals perceive situations in their lives as stressful, unpredictable, uncontrollable, and overwhelming. Items are rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores are calculated by summing item responses after reverse-scoring positively worded items and range from 0 to 40. Higher scores indicate greater perceived stress.
6 weeks
Change in Total Cholesterol
Časové okno: 6 weeks
Change in fasting total cholesterol from baseline to 6 weeks was measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). Total cholesterol was reported in milligrams per deciliter (mg/dL). Desirable levels are less than 200 mg/dL, borderline high levels are 200-239 mg/dL, and high levels are 240 mg/dL or greater. Lower values indicate improved lipid status.
6 weeks
Change in Triglycerides
Časové okno: 6 weeks
Change in fasting triglycerides from baseline to 6 weeks was measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). Triglycerides were reported in milligrams per deciliter (mg/dL). Normal levels are less than 150 mg/dL, borderline high levels are 150-199 mg/dL, high levels are 200-499 mg/dL, and very high levels are 500 mg/dL or greater. Lower values indicate improved lipid status.
6 weeks
Low-Density Lipoprotein cholesterol (LDL-C)
Časové okno: 6 weeks
Change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline to 6 weeks measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). LDL-C was reported in milligrams per deciliter (mg/dL). Optimal levels are less than 100 mg/dL, near optimal levels are 100-129 mg/dL, borderline high levels are 130-159 mg/dL, high levels are 160-189 mg/dL, and very high levels are 190 mg/dL or greater. Lower values indicate improved cardiovascular risk profile.
6 weeks
High-Density Lipoprotein cholesterol (HDL-C)
Časové okno: 6 weeks
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 6 weeks was measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). HDL-C was reported in milligrams per deciliter (mg/dL). Low HDL-C is defined as less than 40 mg/dL for men and less than 50 mg/dL for women. Higher values indicate an improved cardiovascular risk profile
6 weeks
Fasting Blood Glucose
Časové okno: 6 weeks
Change in fasting blood glucose from baseline to 6 weeks measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). Glucose was reported in milligrams per deciliter (mg/dL). Normal fasting glucose ranges from 70-99 mg/dL, prediabetes is defined as 100-125 mg/dL, and diabetes is defined as 126 mg/dL or greater. Lower values indicate improved glycemic status.
6 weeks

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Real-Time Eating Behaviors
Časové okno: Throughout 6-week intervention
Eating context was assessed during the 6-week intervention using ecological momentary assessment (EMA) surveys delivered 3 times per week. Participants reported the mealtime assessed (breakfast, lunch, dinner, or snack), feeling during the meal (rushed, relaxed, stressed, distracted, or other), and meal location (restaurant/dining hall, outside/picnic, car/public transit, work/desk, home, or other). Responses were summarized as frequencies and percentages for each category, with higher percentages indicating more frequent occurrence of that eating context.
Throughout 6-week intervention
EMA Engagement
Časové okno: Throughout the 6 weeks
EMA engagement was assessed during the 6-week intervention using survey completion metrics, including the number of days with completed EMA responses, average completion rate, time to complete surveys, and the time of day at which responses were submitted. Completion rate was calculated as the percentage of EMA surveys completed out of all EMA prompts delivered, with higher percentages indicating greater responsiveness to real-time data collection.
Throughout the 6 weeks
Recruitment Rate
Časové okno: At baseline
Recruitment feasibility was assessed during study enrollment. Recruitment rate was calculated as the proportion of screened individuals who met eligibility criteria and enrolled in the study. Higher percentages indicate greater feasibility of identifying and enrolling participants from the target population.
At baseline
Retention Rate
Časové okno: throughout 6 week period
Participant retention assessed during the 6-week intervention. Retention rate was calculated as the proportion of enrolled participants who completed the intervention and attended follow-up assessments. Higher percentages indicate greater acceptability of the intervention and study procedures.
throughout 6 week period
Intervention Engagement
Časové okno: Throughout the 6 week period
Intervention engagement was assessed during the 6-week intervention using eLearning platform metrics. Engagement was measured by the number of assigned educational modules completed, the proportion of modules completed, and the time spent engaging with intervention content (minutes). Higher values indicate greater engagement with the Mind Your Heart program.
Throughout the 6 week period
Assessment Completion Rate
Časové okno: Throughout the 6 week period
Completion of study assessments was calculated as the proportion of participants who completed anthropometric measurements, blood pressure assessments, blood biomarker collection, dietary records, and questionnaires at baseline and follow-up. Higher percentages indicate greater feasibility of study assessment procedures.
Throughout the 6 week period

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Georgia

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. ledna 2022

Primární dokončení (Aktuální)

15. dubna 2022

Dokončení studie (Aktuální)

1. května 2022

Termíny zápisu do studia

První předloženo

5. června 2026

První předloženo, které splnilo kritéria kontroly kvality

22. června 2026

První zveřejněno (Aktuální)

26. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PROJECT00003799

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified individual participant data (IPD) to be shared will include baseline and follow-up measures of dietary behaviors, dietary intake (e.g., food tracking data), cardiometabolic biomarkers (e.g., blood lipids), blood pressure, anthropometric measures (e.g., weight, BMI, body fat), and ocular nutrient status. Repeated measures data from mobile-based questionnaires assessing real-time eating behaviors will also be included. Demographic variables (e.g., age, sex) necessary for analysis will be provided. All datasets will be stripped of direct identifiers and coded to protect participant confidentiality.

Časový rámec sdílení IPD

Beginning 1 year after publication with no end date

Kritéria přístupu pro sdílení IPD

Access to de-identified individual participant data (IPD) will be granted to qualified researchers for scientific research purposes, including replication or secondary analyses consistent with the original study aims. Requests must include a brief research proposal outlining objectives, analytic plan, and data security procedures. Proposals will be reviewed by the study investigators to ensure scientific merit, feasibility, and protection of participant confidentiality. Approved users will be required to sign a data use agreement specifying conditions of use, data security requirements, and prohibition of re-identification. Requests and supporting documents should be submitted via email to the study investigators, and data will be shared using secure, institutionally approved transfer methods.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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