Objective: To estimate the behavioral benefits and psychological costs of specific digital dietary self-monitoring interfaces, defining the causal effect of high-salience algorithmic feedback and tracking intensity on momentary food-related distress and orthorexia-related symptom trajectories.
Design: A 12-week, 2×2 factorial randomized controlled explanatory sequential mixed-methods trial (QUAN → qual), structured according to SPIRIT 2025 guidelines.
Participants: Adequately powered adult cohort (N=420) without active clinical eating disorders.
Primary Estimand: The intention-to-treat (ITT) average treatment effect of assigned high-salience algorithmic feedback on mean momentary food-related distress over 12 weeks.
Analysis: Factorial linear mixed-effects modeling (LMM), lagged multilevel mediation, and pattern-mixture models. Purposively sampled qualitative interviews provide explanatory mechanistic integration.
While dietary self-monitoring drives adherence, observational evidence robustly links it to disordered eating. Recent systematic reviews explicitly state that causal direction and interface-level mechanisms remain unresolved, highlighting the need to separate behavioral benefits from psychological harm.
This protocol tests seven prespecified hypotheses:
To prevent confounding adherence with psychological cost, we formalize Algorithmic Affective Cost (AAC) as a population-level causal estimand: the ITT average treatment effect of assigned high-salience feedback on momentary distress.
Exposure is strictly partitioned:
Primary inference relies exclusively on Ai, while Dit and Rit inform exploratory dose-response models.
Defined operationally as a composite score of EMA-derived shame, guilt, and anxiety. Time-varying variables are decomposed to isolate within-person deviations from between-person traits:
H4 Temporal Event Indexing:
Nutritional algorithms are identical across all arms; only interface psychology is manipulated.
| Neutral Feedback | High-Salience Feedback | |
|---|---|---|
| Low Intensity | Arm A: 2 logs/day. Raw numerical data. No color coding, evaluative language, or push notifications. | Arm B: 2 logs/day. Red deficit/surplus indicators, push-alert warnings, progress streaks. |
| High Intensity | Arm C: 6 logs/day. Neutral interface. | Arm D: 6 logs/day. High-salience interface. |
Sample size was derived via Monte Carlo simulation targeting ≥90% power for the F×S interaction.
| Parameter | Prespecified Value |
|---|---|
| Randomization (N) | 420 (1:1:1:1 allocation) |
| Expected Attrition | 20% (Sensitivity at 10% / 30%) |
| EMA Compliance Threshold | ≥70% |
| Residual Covariance | AR(1), ρ=0.35 |
| Target Power | ≥90% (10,000 replications) |
Estimands: β3 tests H1 (average effect of salience). β4 tests H3 (interaction). Time interactions (β5,β6,β7) represent secondary trajectory deviations from the primary average effect.
Given the manipulation of evaluative dietary feedback, strict safety thresholds trigger immediate independent Data and Safety Monitoring Board (DSMB) review:
Following quantitative analysis, 40-60 participants will be purposively sampled based on predefined trajectory criteria (e.g., top quartile of distress escalation) rather than latent class discovery. Reflexive thematic analysis will populate a QUAN → QUAL joint display to contextually explain why specific interface trajectories occurred.
| Assessment | Baseline | Wk 1 | Wk 4 | Wk 8 | Wk 12 | Follow-Up (Wk 16) |
|---|---|---|---|---|---|---|
| EAT-26 (Safety) | ✓ | ✓ | ✓ | ✓ | ✓ | |
| EHQ / MAIA | ✓ | ✓ | ✓ | ✓ | ✓ | |
| STAI-T (Trait) | ✓ | |||||
| EMA (Distress) | ✓ | ✓ | ✓ | ✓ | ||
| Telemetry | ✓ | ✓ | ✓ | ✓ | ||
| UI Manipulation Check | ✓ | ✓ |