Mediterranean diet app intervention for atrial fibrillation patients

Clinical Score: 0.950 Price: $0.50 atrial fibrillation human patients Status: proposed

What This Experiment Tests

Clinical experiment designed to assess clinical efficacy targeting N/A in human patients. Primary outcome: feasibility (retention rate) and inflammatory biomarkers

Description

This single-arm pre-post pilot study evaluated the feasibility and preliminary effects of a Mediterranean diet self-monitoring mobile application (Olitor) in patients with symptomatic paroxysmal atrial fibrillation. Participants used the app for 3 months, which prompted weekly diet tracking and provided tailored feedback based on Mediterranean diet principles. The study assessed multiple outcomes including inflammatory biomarkers (interleukin-6 and C-reactive protein), atrial fibrillation symptoms, quality of life measures, physical activity levels, diet knowledge, self-efficacy, and body mass index. The intervention aimed to reduce inflammation through dietary modification, potentially improving symptom burden and quality of life in AF patients. Results showed promising trends with reductions in inflammatory markers, improvements in quality of life (particularly in the family QoL subdomain with large effect size), increased walking activity, and gains in self-efficacy and diet knowledge. The study demonstrated good retention rates and feasibility of the digital health intervention approach.

TARGET GENE

N/A

MODEL SYSTEM

human patients

ESTIMATED COST

TIMELINE

0 months

PATHWAY

inflammatory pathways

SOURCE

extracted_from_pmid_41945364

PRIMARY OUTCOME

feasibility (retention rate) and inflammatory biomarkers

Scoring Dimensions

📖 Wiki Pages

Biomarkersindex

Protocol

Study Title: Mobile Health Mediterranean Diet Intervention for Atrial Fibrillation Patients: A Randomized Controlled Feasibility Trial

Protocol Version: 1.0 Study Registration: ClinicalTrials.gov (pending) Funding Source: Institutional Research Grant

STUDY OVERVIEW

Design: Two-arm parallel-group randomized controlled trial (RCT) Population: Adults with paroxysmal or persistent atrial fibrillation (AF) Sample Size: 60 participants (30 per arm) Duration: 24 weeks (6 months) Setting: Single-center, outpatient

PHASE STRUCTURE

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Study Title: Mobile Health Mediterranean Diet Intervention for Atrial Fibrillation Patients: A Randomized Controlled Feasibility Trial

Protocol Version: 1.0 Study Registration: ClinicalTrials.gov (pending) Funding Source: Institutional Research Grant

STUDY OVERVIEW

PHASE STRUCTURE

Phase 1: Screening & Baseline (Week -2 to 0)

Screening Visit (Visit 1): Informed consent, eligibility confirmation, medical history, physical exam, 12-lead ECG, blood draw for baseline inflammatory biomarkers
Baseline Assessment (Visit 2, Week 0): Dietary assessment (Mediterranean Diet Score questionnaire), quality of life (SF-36, AF-specific symptom burden), physical activity monitoring (accelerometer), blood draw (fasting), anthropometrics
Randomization: Block randomization (block size 4), stratified by AF type (paroxysmal vs persistent)

Phase 2: Run-in & App Training (Week 0 to Week 2)

Group A (Intervention): Install MedDiet-AF app; 60-minute individualized training session on app usage, Mediterranean diet principles, portion estimation; receive digital food diary setup
Group B (Control): Receive standard written dietary guidelines (ADA brochure); 15-minute nurse education session on general heart-healthy eating
Dietary Compliance Assessment: 3-day food diaries collected at Week 1 (phone follow-up)

Phase 3: Active Intervention (Week 2 to Week 16)

Intervention Group (MedDiet-AF App):
Daily app check-ins: photo-based meal logging (breakfast, lunch, dinner + 2 snacks)
Automated feedback: personalized Mediterranean diet score (0-100 scale) updated daily
Weekly push notifications: educational content on Mediterranean diet components (olive oil, fish, nuts, vegetables)
Bi-weekly dietitian coaching calls (15-20 min each)
App incorporates: Oleic acid tracking, Omega-3 index estimation, polyphenol intake proxy
Control Group (Standard Care):
Monthly newsletter on general heart-healthy eating (no personalized feedback)
No dietary coaching calls
Quarterly check-in call to maintain engagement

Phase 4: Mid-point Assessment (Week 8)

Visit 3 (Week 8): Blood draw (inflammatory biomarkers), 3-day food diary review, app engagement metrics (intervention only), adverse events, medication review, SF-36 questionnaire, AF symptom burden score

Phase 5: End-of-Intervention Assessment (Week 16)

Visit 4 (Week 16): Blood draw (fasting, 8-12 hour overnight fast), anthropometrics, 3-day food diary, Mediterranean Diet Score questionnaire, SF-36, AF-specific symptom burden, physical activity accelerometer 7-day wear, medication review, adverse events, app satisfaction survey (intervention)

Phase 6: Follow-up (Week 16 to Week 24)

No active intervention — participants maintain usual diet
Visit 5 (Week 24): Final blood draw, anthropometrics, dietary assessment, quality of life questionnaires, AF symptom burden, healthcare utilization recall, safety assessment

METHODS

Inclusion Criteria

Age 40-80 years
Documented paroxysmal or persistent AF (confirmed by ECG, Holter, or implantable device)
Stable anticoagulation for ≥4 weeks
Smartphone ownership with data plan
Able to read/understand English
Medically stable (CHF class I-II, no unstable angina, no recent MI within 3 months)

Exclusion Criteria

Severe renal impairment (eGFR <30 mL/min/1.73m²)
Active liver disease
Omega-3 supplementation >2g/day
Current participation in another dietary intervention trial
Life expectancy <12 months
Cognitive impairment precluding app use
Prior Mediterranean diet adherence score ≥8/14 on MEDAS questionnaire

Intervention: MedDiet-AF App

Platform: iOS and Android native application
Developer: Academic research team with validated Mediterranean diet scoring algorithm
Key Features:
Photo-based meal logging with automatic food identification
Mediterranean Diet Adherence Score (MDAS) algorithm using Mediterranean Diet Screener (MEDAS-14) items
Personalized daily/weekly MDAS feedback
Integration with Apple HealthKit/Google Fit for physical activity
Push notification schedule: 3 reminders/week for meal logging

Control Intervention

Standard care with written materials only (American Heart Association Dietary Guidelines pamphlet)
No personalized feedback or coaching

Biomarker Collection

Blood collection: 10 mL venous blood in EDTA tubes, placed on ice, centrifuged within 30 min at 2000×g for 15 min at 4°C
Storage: Plasma aliquoted into cryovials, stored at -80°C until analysis
Batch analysis: All samples analyzed in duplicate in a single batch at study completion, blinded to group assignment

Inflammatory Biomarkers (ELISA)

High-sensitivity C-reactive protein (hs-CRP): R&D Systems Human CRP ELISA Kit (Cat# DCRP00), sensitivity 0.022 mg/L
Interleukin-6 (IL-6): R&D Systems Human IL-6 Quantikine ELISA Kit (Cat# D6050), sensitivity 0.039 pg/mL
Tumor necrosis factor-alpha (TNF-α): R&D Systems Human TNF-α Quantikine ELISA Kit (Cat# DTA00D), sensitivity 0.5 pg/mL
Interleukin-1β (IL-1β): R&D Systems Human IL-1β ELISA Kit (Cat# DLB50), sensitivity 0.125 pg/mL
Soluble intercellular adhesion molecule-1 (sICAM-1): R&D Systems Human sICAM-1 ELISA Kit (Cat# DCD540), sensitivity 0.096 ng/mL

Dietary Assessment

Mediterranean Diet Adherence Screener (MEDAS-14): Validated 14-item questionnaire administered at baseline, Week 8, Week 16, Week 24
3-day food diaries: 2 weekdays + 1 weekend day, analyzed using Nutrition Data System for Research (NDSR) software
Plasma fatty acid profile: Gas chromatography-flame ionization detection (GC-FID) for Omega-3 Index (脂肪酸甲基酯分析)

AF Symptom Assessment

AF Symptom Burden Questionnaire: Heart Rhythm Society AF symptom classification (Class I-IV)
AF生活质量问卷 (AFEQT): Atrial Fibrillation Effect on QualiTy of Life questionnaire
Symptom diary: Daily symptom check-in via app (intervention) or paper diary (control)

Quality of Life

SF-36v2 Health Survey: Standardized QoL instrument
Physical Activity: ActiGraph GT9X accelerometer, 7-day wear, wear time validation ≥4 days with ≥10 hours/day

STUDY TIMELINE

| Phase | Timepoint | Key Activities |
|-------|-----------|----------------|
| 1 | Week -2 to 0 | Screening, consent, baseline blood draw, randomization |
| 2 | Week 0 to 2 | App training (intervention) or education (control), run-in |
| 3 | Week 2 to 16 | Active intervention period |
| 4 | Week 8 | Mid-point assessment, blood draw, interim analysis |
| 5 | Week 16 | End-of-intervention assessment |
| 6 | Week 24 | Final follow-up assessment |

STATISTICAL ANALYSIS PLAN

Primary Outcome: Retention rate (proportion of randomized participants completing Week 24 assessment)

Non-inferiority margin: 15% (intervention vs control retention ≥85% of control)

Secondary Outcomes:

Change in hs-CRP from baseline to Week 16
Change in Mediterranean Diet Score (MEDAS-14) from baseline to Week 16
Change in AF symptom burden from baseline to Week 16

Sample Size Justification:

N=60 provides 80% power to detect a 20% difference in retention rate (85% vs 65%), assuming α=0.05 (one-sided)
For inflammatory biomarkers: N=30 per group provides 80% power to detect d=0.74 effect size (medium) in change from baseline, assuming α=0.05

Analytical Approach:

Intention-to-treat (ITT) analysis for all primary and secondary outcomes
Mixed-effects linear models for repeated measures
Multiple imputation for missing data under missing-at-random assumption
Bonferroni correction for multiple inflammatory biomarker comparisons

Expected Outcomes

Retention Rate: ≥85% (51/60) of randomized participants complete the Week 24 assessment in both arms, with the intervention arm showing non-inferiority (expected 87-90% retention)

hs-CRP Reduction: Mean reduction of 1.8 ± 1.2 mg/L in the intervention group vs 0.4 ± 1.1 mg/L in the control group at Week 16 (between-group difference: -1.4 mg/L, 95% CI: -2.0 to -0.8 mg/L), p < 0.001

Mediterranean Diet Adherence: Mean increase of 4.2 ± 1.8 points on MEDAS-14 in intervention group vs 1.1 ± 1.4 points in control group at Week 16 (effect size d = 1.9)

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Success Criteria

Retention ≥85%: At least 51 of 60 randomized participants complete the Week 24 primary assessment; Chi-square test p-value > 0.05 for between-group comparison demonstrating non-inferiority
hs-CRP effect size ≥0.5: Between-group standardized mean difference (Cohen's d) in hs-CRP change from baseline to Week 16 ≥ 0.5, with two-sided p-value < 0.05
Mediterranean Diet adherence increase ≥3 points: Intervention group MEDAS-14 score increases by ≥3 points from baseline at Week 16; independent samples t-test p < 0.001

...

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Mediterranean diet app intervention for atrial fibrillation patients

What This Experiment Tests

Description

Scoring Dimensions

📖 Wiki Pages

Protocol

STUDY OVERVIEW

PHASE STRUCTURE

STUDY OVERVIEW

PHASE STRUCTURE

Phase 1: Screening & Baseline (Week -2 to 0)

Phase 2: Run-in & App Training (Week 0 to Week 2)

Phase 3: Active Intervention (Week 2 to Week 16)

Phase 4: Mid-point Assessment (Week 8)

Phase 5: End-of-Intervention Assessment (Week 16)

Phase 6: Follow-up (Week 16 to Week 24)

METHODS

Inclusion Criteria

Exclusion Criteria

Intervention: MedDiet-AF App

Control Intervention

Biomarker Collection

Inflammatory Biomarkers (ELISA)

Dietary Assessment

AF Symptom Assessment

Quality of Life

STUDY TIMELINE

STATISTICAL ANALYSIS PLAN

Expected Outcomes

Success Criteria

SAFETY MONITORING

ETHICS

Related Hypotheses (0)

Debate History (0)

Experiment Results (0)