Back to resultsThe Lifestyle Exercise and Diet Trial (LEAD) 2.0
Primary Purpose
Subjective Cognitive Decline
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EX
DIET
STRETCH
ED
Sponsored by
About this trial
This is an interventional prevention trial for Subjective Cognitive Decline
Eligibility Criteria
Inclusion Criteria: 65-80 years old Meet criteria for executive SCD Answer Yes to both following questions: Do you feel like your memory or thinking is becoming worse? Does this worry you? ≥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. 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 Able to communicate in English Residents of Quebec, Ontario, Manitoba, and Saskatchewan to facilitate concurrent intervention delivery Low physical activity levels (<75min/week of moderate/vigorous physical activity on the Get Active Questionnaire) 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 Poor diet quality (below Canadian older adults' median intake of fruits, vegetables, nuts and fish, reported using our Diet Screening Questionnaire) 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
Sites / Locations
- University of WaterlooRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
EX + DIET
EX + ED
STRETCH + DIET
STRETCH + ED
Arm Description
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).
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).
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).
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)
Outcomes
Primary Outcome Measures
Feasibility: Recruitment
Recruitment rate per month
Feasibility: Retention
Percent of consented participants who complete the post-intervention assessment of executive function
Feasibility: Adherence
Percent of study intervention sessions attended by type
Feasiliby: Adherence (diet)
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
Retention by gender
Does retention vary by gender (men, women, other)
Adherence by gender
Does adherence vary by gender (men, women, other)
Executive Function
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.
Memory
a secondary outcome of a future, large scale trial: memory (Rey Auditory verbal Learning Test [RAVLT] immediate and delayed recall)
Diet
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])
Physical Activity
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
a secondary outcome of a future, large scale trial: physical function (assessed using a 5 times sit-to-stand test)
Health-related quality of life
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)
Waist Circumference
a secondary outcome of a future, large scale trial: waist circumference
Maintenance of change in executive function
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 diet quality
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)
Maintenance of physical activity
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)
Effect modification of executive function by sex
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
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)
Effect modification of physical activity by sex
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
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 sex
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)
Effective modification of diet quality by gender
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)
Full Information
NCT ID
NCT06078748
First Posted
June 1, 2023
Last Updated
October 15, 2023
Sponsor
University of Waterloo
Collaborators
Baycrest, Université de Montréal, University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT06078748
Brief Title
The Lifestyle Exercise and Diet Trial (LEAD) 2.0
Official Title
The Lifestyle, Exercise, and Diet Trial: A Virtual, Lifestyle Approach to Improve Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Waterloo
Collaborators
Baycrest, Université de Montréal, University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Factorial randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Outcome assessors will be masked to intervention group.
Careful wording will be used to describe the intervention groups to participants as to not disclose whether they are in experimental or control groups. For instance, all participants will be told that they will be receiving different combinations of exercise (stretching/toning is the control for aerobic/resistance exercise) and healthy lifestyle interventions (lifestyle education is control for dietary intervention).
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EX + DIET
Arm Type
Experimental
Arm Description
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).
Arm Title
EX + ED
Arm Type
Active Comparator
Arm Description
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).
Arm Title
STRETCH + DIET
Arm Type
Active Comparator
Arm Description
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).
Arm Title
STRETCH + ED
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
EX
Other Intervention Name(s)
Combined aerobic and resistance exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DIET
Other Intervention Name(s)
Brain-healthy diet education and counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
STRETCH
Other Intervention Name(s)
Stretching and toning exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ED
Other Intervention Name(s)
Brain Health Education and Discussion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: Recruitment
Description
Recruitment rate per month
Time Frame
6 months
Title
Feasibility: Retention
Description
Percent of consented participants who complete the post-intervention assessment of executive function
Time Frame
6 months
Title
Feasibility: Adherence
Description
Percent of study intervention sessions attended by type
Time Frame
6 months
Title
Feasiliby: Adherence (diet)
Description
Change in diet quality as assessed with the Eating Pattern Self-Assessment (minimum score 0, maximum score 15; higher scores indicate better diet quality)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Retention by gender
Description
Does retention vary by gender (men, women, other)
Time Frame
6 months
Title
Adherence by gender
Description
Does adherence vary by gender (men, women, other)
Time Frame
6 months
Title
Executive Function
Description
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.
Time Frame
6 months
Title
Memory
Description
a secondary outcome of a future, large scale trial: memory (Rey Auditory verbal Learning Test [RAVLT] immediate and delayed recall)
Time Frame
6 months
Title
Diet
Description
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])
Time Frame
6 months
Title
Physical Activity
Description
a secondary outcome of a future, large scale trial: physical activity (Physical Activity Scale for the Elderly [PASE], higher scores indicated more physical activity)
Time Frame
6 months
Title
Physical Function
Description
a secondary outcome of a future, large scale trial: physical function (assessed using a 5 times sit-to-stand test)
Time Frame
6 months
Title
Health-related quality of life
Description
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)
Time Frame
6 months
Title
Waist Circumference
Description
a secondary outcome of a future, large scale trial: waist circumference
Time Frame
6 months
Title
Maintenance of change in executive function
Description
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
Time Frame
12 months
Title
Maintenance of diet quality
Description
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)
Time Frame
12 months
Title
Maintenance of physical activity
Description
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)
Time Frame
12 months
Title
Effect modification of executive function by sex
Description
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)
Time Frame
6 months
Title
Effect modification of executive function by gender
Description
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)
Time Frame
6 months
Title
Effect modification of physical activity by sex
Description
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)
Time Frame
12 months
Title
Effect modification of physical activity by gender
Description
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)
Time Frame
12 months
Title
Effective modification of diet quality by sex
Description
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)
Time Frame
12 months
Title
Effective modification of diet quality by gender
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65-80 years old
Meet criteria for executive SCD
Answer Yes to both following questions:
Do you feel like your memory or thinking is becoming worse?
Does this worry you?
≥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.
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
Able to communicate in English
Residents of Quebec, Ontario, Manitoba, and Saskatchewan to facilitate concurrent intervention delivery
Low physical activity levels (<75min/week of moderate/vigorous physical activity on the Get Active Questionnaire)
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
Poor diet quality (below Canadian older adults' median intake of fruits, vegetables, nuts and fish, reported using our Diet Screening Questionnaire)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bobby J Neudorf, BSc
Phone
5198884567
Ext
41080
Email
bjneudor@uwaterloo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole D Anderson, PhD
Phone
(416) 785-2500
Ext
3366
Email
nanderson@research.baycrest.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Middleton, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
41080
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobby Neudorf, BSc
Phone
+1-519-888-4567
Ext
41080
Email
bjneudor@uwaterloo.ca
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IDP will be uploaded to an open access data repository. The exact repository has yet to be decided. All data will be de-identified.
IPD Sharing Time Frame
Study protocol, analysis plan, and consent forms will become available shortly after ethics approval.
Clinical study reports will become available after the last data collection and analysis in December 2025. The data will remain on the repository indefinitely.
IPD Sharing Access Criteria
Open access
Learn more about this trial
The Lifestyle Exercise and Diet Trial (LEAD) 2.0
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