The Lifestyle Exercise and Diet Trial (LEAD) 2.0

NAActive, not recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

October 3, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Subjective Cognitive Decline
Interventions
BEHAVIORAL

EX

"EX involves 2.5hrs of moderate intensity aerobic and resistance exercise per week. EX will be instructed by a clinical exercise physiologist (CEP) or registered kinesiologist (RKIN). The EX session will include a 5min warm-up, 20-30min of moderate intensity aerobic exercise, 20-30min of moderate intensity resistance training, and a 5min cool down. The virtual video session will be pre-recorded, have similar composition, and will be led by the same instructor as the group sessions. This group will also receive the Adult Strategies Put Into Real World Environments (ASPIRE) goal strategy training, with goals focused on exercise in order to overcome barriers and increase maintenance of lifestyle changes."

BEHAVIORAL

DIET

"DIET involves one session per week of diet education delivered by a Registered Dietitian. The DIET session will be 90 minutes during months 1-4, and 30 minutes in months 5 and 6. DIET was developed by our team, emphasizing foods identified as supporting executive function, memory, and other cognitive abilities. This group will also receive the Adult Strategies Put Into Real World Environments (ASPIRE) goal strategy training, with goals focused on diet in order to overcome barriers and increase maintenance of lifestyle changes."

BEHAVIORAL

STRETCH

STRETCH sessions will be time/frequency-matched to EX sessions (2.5hrs/week: 1.5hr in virtual group sessions; 1hr virtual video session) to control for social aspects and placebo effects of EX.Each STRETCH session will include a 5min warm-up, 5min of balance exercises, and 50min of stretching. Difficulty will not be progressed. STRETCH sessions will also be led by a CEP/RKIN instructor and video sessions will be pre-recorded by the same instructor.

BEHAVIORAL

ED

ED sessions designed to be of equal intensity and social engagement to the DIET intervention. Participants will engage in group discussion and receive information on the brain and cognitive processes, the effect of age on cognition, and tips to promote healthy aging. This will include lectures, watching documentaries and participating in various games.

Trial Locations (1)

41080

University of Waterloo, Waterloo

All Listed Sponsors
collaborator

Baycrest

OTHER

collaborator

Université de Montréal

OTHER

collaborator

University of Ottawa

OTHER

lead

University of Waterloo

OTHER

NCT06078748 - The Lifestyle Exercise and Diet Trial (LEAD) 2.0 | Biotech Hunter | Biotech Hunter