{"type":"trials","record":{"id":35405,"source_id":"clinicaltrials-gov","external_id":"NCT05827094","title":"Pilot Mobile for Dementia and Frailty","brief_summary":"In this project, we propose to build on our Stage I formative work (according to the NIH Stage Model for Behavioral Intervention Development), where we developed fully functional prototypes of a mobile intervention aimed at improving adherence to Mediterranean Diet (MedD) for older adults with frailty and early dementia to complete the Stage II exploratory work, where the intervention will undergo further feasibility, acceptability, and preliminary efficacy tests. The intervention includes a patient-facing app that allows users to track their diet and receive personalized feedback concerning opportunities for improvement and recipes for breakfast, lunch, dinner, and snacks, informational materials about MedD, and a chat feature. On the other end, a web-based provider interface allows clinicians to review patient progress, suggest meal plans, and send and receive messages. The pilot randomized controlled trial, conducted over three months, will compare usual care to usual care plus mobile intervention to gather preliminary efficacy data concerning a change in adherence to MedD score (primary outcome). Mechanistic and secondary outcomes will include MedD knowledge, constructs from Social Cognitive Theory (self-efficacy, outcome expectation, self-regulation, and social support), platform use, anthropometric, and functional measures. Feasibility will be evaluated in terms of recruitment and retention outcomes. Acceptability will be determined through post-intervention semi-structured interviews and structured survey measures.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Washington","enrollment":19,"countries":["United States"],"start_date":"2023-06-06","completion_date":"2024-03-15","last_update_date":"2025-03-13","source_url":"https://clinicaltrials.gov/study/NCT05827094","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:25:45.678+00:00","metadata":{"sex":"ALL","acronym":"Mindful Meals","age_range":"65 Years","comparator":"Usual Care","organization":"University of Washington","interventions":["Mobile app","Usual Care"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Adherence to Mediterranean Diet (aMed) Score. The Change Was Calculated From Two Time Points as the Value at…","Short Physical Performance Battery — Baseline; 12 weeks","Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire — Baseline; 12 weeks","Waist Circumference (WC) — Baseline; 12 weeks","Body Mass Index — Baseline; 12 weeks","Social Cognitive Theory — Baseline; 12 weeks"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","source_has_results":true},"controlled_terms":["Dementia","Frailty","Mobile app","Usual Care"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:25:48.368501+00:00","duplicate_cluster_key":"id:nct05827094","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-06-06 to 2024-03-15","comparator":"Usual Care","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:45.714Z","intervention":["Mobile app","Usual Care"],"participants":19,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change in Adherence to Mediterranean Diet (aMed) Score. The Change Was Calculated From Two Time Points as the Value at…","Short Physical Performance Battery — Baseline; 12 weeks","Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire — Baseline; 12 weeks","Waist Circumference (WC) — Baseline; 12 weeks","Body Mass Index — Baseline; 12 weeks","Social Cognitive Theory — Baseline; 12 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35405","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}