Clinical Trial

The Lifestyle Exercise and Diet Trial (LEAD) 2.0

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated April 4, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The objective of this study is to investigate the feasibility of a virtually-delivered 6-month exercise and nutrition intervention in older adults with executive subjective cognitive decline (SCD). Feasibility will be determined by recruitment, retention, and adherence rates. Preliminary changes in cognition, physical function, and quality of life will be assessed as secondary outcomes. The study will recruit 140 participants aged 65 to 80 who report they feel that their memory or other thinking abilities are declining. Participants will be randomized into one of four study arms receiving different combinations of healthy lifestyle interventions. Assessments will be conducted virtually at baseline, post-intervention (6 months), and follow-up (12 months). All intervention sessions and assessment visits will be conducted online using the Zoom Healthcare platform and participants will log on using their own devices from home.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-03; most recent amendment 2025-04-02.
Status change: Recruiting → Active, Not Recruiting 2025-04-02
Trial Details
NCT Number NCT06078748
Lead Sponsor University of Waterloo
Collaborators: Baycrest, Université de Montréal, University of Ottawa
Conditions Subjective Cognitive Decline
Enrollment 140 participants
Start Date 2023-10-03
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-04