The Lifestyle Exercise and Diet Trial (LEAD) 2.0

NCT06078748 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Waterloo

Phase

Not applicable

Started

2023-10-03

Last updated

2025-04-04

Condition(s) studied

Subjective Cognitive Decline

Investigational drug(s) / intervention(s)

EXDIETSTRETCHED

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.

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.

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. 65-80 years old 2. Meet criteria for executive SCD 1. Answer Yes to both following questions: * Do you feel like your memory or thinking is becoming worse? * Does this worry you? 2. ≥1SD above age and sex-based means on any of the sub scales of the Comprehensive Executive Function Inventory (CEFI) - Adult Version, indicative of concerns about executive function. 3. No objective cognitive impairment as indicated by: * A global Clinical Dementia Rating (CDR) of ≤ 0.5 * A Blind Montreal Cognitive Assessment (MoCA) total score of \>17 3. Able to communicate in English 4. Residents of Quebec, Ontario, Manitoba, and Saskatchewan to facilitate concurrent intervention delivery 5. Low physical activity levels (\<75min/week of moderate/vigorous physical activity on the Get Active Questionnaire) 6. Screened safe to participate in moderate exercise using the Get Active Questionnaire or physician approval to engage in moderate intensity exercise without in-person supervision 7. Poor diet quality (below Canadian older adults' median intake of fruits, vegetables, nuts and fish, reported using our Diet Screening Questionnaire) 8. Able to participate remotely (i.e., availability of, or ability/willingness to adopt, a computer or tablet alongside high speed internet/data networks) Exclusion Criteria: * Dementia, stroke, or other chronic brain disease * Chemotherapy or radiation to the head/neck in the past year * Sensory impairments that would impede participation in the intervention or assessments * Major psychiatric disorder * Ongoing alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures. * Contraindications for exercise as determined by the American College of Sports Medicine criteria

Primary outcome measure(s)

Feasibility: Recruitment — 6 months
Recruitment rate per month
Feasibility: Retention — 6 months
Percent of consented participants who complete the post-intervention assessment of executive function
Feasibility: Adherence — 6 months
Percent of study intervention sessions attended by type
Feasiliby: Adherence (diet) — 6 months
Change in diet quality as assessed with the Eating Pattern Self-Assessment (minimum score 0, maximum score 15; higher scores indicate better diet quality)

Trial sites (1)

Facility	City	Region	Status
University of Waterloo	Waterloo	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06078748 on ClinicalTrials.gov ↗ ← All trials in Canada