The Lifestyle Exercise and Diet Trial (LEAD) 2.0

Not Applicable

Active, not recruiting

• Conditions: Subjective Cognitive Decline
• Interventions: Behavioral: EX; Behavioral: STRETCH; Behavioral: ED; Behavioral: DIET

• Registration Number: NCT06078748
• Lead Sponsor: University of Waterloo

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-01
• Study Start: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
EX + DIET	EX	Participants will engage in 3 sessions per week (2 EX, 1 DIET, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
EX + ED	EX	Participants will engage in 3 sessions per week (2 EX, 1 ED, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
EX + ED	ED	Participants will engage in 3 sessions per week (2 EX, 1 ED, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
STRETCH + ED	ED	Participants will engage in 3 sessions per week (2 STRETCH, 1 ED) totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet)
EX + DIET	DIET	Participants will engage in 3 sessions per week (2 EX, 1 DIET, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
STRETCH + ED	STRETCH	Participants will engage in 3 sessions per week (2 STRETCH, 1 ED) totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet)
STRETCH + DIET	DIET	Participants will engage in 3 sessions per week (2 STRETCH, 1 DIET, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).
STRETCH + DIET	STRETCH	Participants will engage in 3 sessions per week (2 STRETCH, 1 DIET, totaling 4 hours per week), consisting of two virtual group sessions (totaling 3 hours) and one independent session (1 hour) (Table 1). Virtual group sessions will occur in groups of 6-8 participants using the Zoom Healthcare platform (on a computer or tablet).

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Memory	6 months	a secondary outcome of a future, large scale trial: memory (Rey Auditory verbal Learning Test \[RAVLT\] immediate and delayed recall)
Physical Activity	6 months	a secondary outcome of a future, large scale trial: physical activity (Physical Activity Scale for the Elderly \[PASE\], higher scores indicated more physical activity)
Physical Function	6 months	a secondary outcome of a future, large scale trial: physical function (assessed using a 5 times sit-to-stand test)
Retention by gender	6 months	Does retention vary by gender (men, women, other)
Adherence by gender	6 months	Does adherence vary by gender (men, women, other)
Diet	6 months	a secondary outcome of a future, large scale trial: diet quality (adherence to the study diet assessed by a study-specific questionnaire \[Eating Patterns Self Assessment questionnaire: minimum score 0, maximum score 15; higher scores indicate better diet quality\])
Waist Circumference	6 months	a secondary outcome of a future, large scale trial: waist circumference
Maintenance of change in executive function	12 months	Differences in executive function betwen 6 and 12 months (6 months post-intervention) in an executive function composite derived from Cambridge Brain Sciences on-line assessments
Maintenance of physical activity	12 months	Differences in physical activity (as measured by the Physical Activity Scale for the Elderly, higher scores indicate greater physical activity) between 6 and 12 months (6 months post-intervention)
Executive Function	6 months	the primary outcome of a future, large scale trial: an executive function composite derived from Cambridge Brain Sciences on-line assessments, where calculated effect size, variance, and co-variance will inform the sample size for the future, definitive RCT.
Maintenance of diet quality	12 months	Differences in diet quality (as measured by the Eating Patterns Self-Assessment questionnaire: minimum score 0, maximum score 15; higher scores indicate better diet quality) between 6 and 12 months (6 months post-intervention)
Effect modification of executive function by sex	6 months	To examine differences in observed effect sizes of executive function (as measured by an executive function composite derived from Cambridge Brain Sciences on-line assessments) vary by sex (male/female)
Effect modification of executive function by gender	6 months	To examine differences in observed effect sizes of executive function (as measured by an executive function composite derived from Cambridge Brain Sciences on-line assessments) vary by gender (men, women, other)
Health-related quality of life	6 months	a secondary outcome of a future, large scale trial: Health-related Quality of Life assessed using the SF-36; minimum score 0, maximum score 100, higher scores indicate better quality of life)
Effective modification of diet quality by sex	12 months	To examine differences in observed effect sizes for diet quality (measured by Eating Patterns Self-Assessment questionnaire; minimum score 0, maximum score 15, higher scores indicate better diet quality) by sex (male/female)
Effect modification of physical activity by sex	12 months	To examine differences in observed effect for physical activity (as measured by the Physical Activity Scale for the Elderly, higher scores indicate more physical activity) vary by sex (male/female)
Effect modification of physical activity by gender	12 months	To examine differences in observed effect for physical activity (as measured by the Physical Activity Scale for the Elderly, higher scores indicate more physical activity) vary by gender (men, women, other)
Effective modification of diet quality by gender	12 months	To examine differences in observed effect sizes for diet quality (measured by Eating Patterns Self-Assessment questionnaire; minimum score 0, maximum score 15, higher scores indicate better diet quality) by gender (men, women, other)

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada