NCT06078748

The Lifestyle Exercise and Diet Trial (LEAD) 2.0

The Lifestyle, Exercise, and Diet Trial: A Virtual, Lifestyle Approach to Improve Cognition

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Waterloo · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be a randomized control trial examining the feasibility of a 6-month virtually delivered exercise and nutrition intervention in older adults with executive SCD. The study aims to recruit 140 participants. After initial contact with potential participants, 2 screening visits (up to 45 minutes each) will be conducted to assess eligibility and obtain consent to participate in the study. At the start of the program, after completing the program (6 months), and at follow-up (12 months), assessors will conduct 2 assessments (30-65 min each) using Zoom video conferencing to measure thinking abilities, physical function, and quality of life. Participants will be randomized into one of four 6-month intervention arms (35 individuals per group x 4 groups): 1) EX + DIET: aerobic and resistance exercise (EX) with healthy diet counseling (DIET), 2) EX + ED: aerobic and resistance exercise (EX) with education on healthy lifestyle related to brain health (ED), 3) STRETCH + DIET: stretching and toning exercises (STRETCH) with healthy diet counseling (DIET), 4) STRETCH + ED: stretching and toning exercises (STRETCH) with education on healthy lifestyle related to brain health (ED). All groups that receive EX and/or DIET will also receive the "Adult Strategies Put Into Real World Environments" (ASPIRE) goal strategy training, with goals focused on exercise and/or diet in order to overcome barriers and increase maintenance of lifestyle changes. 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.

Conditions

• Subjective Cognitive Decline

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-10-12
• Last updated: 2025-04-04

Locations

1 site across 1 country: Canada