Subjective Cognitive DeclineNCT06078748
The Lifestyle Exercise and Diet Trial (LEAD) 2.0
A study testing EX, DIET and STRETCH in people with Subjective Cognitive Decline, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- EX, DIET and STRETCH
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Lifestyle, Exercise, and Diet Trial: A Virtual, Lifestyle Approach to Improve Cognition
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.
Read the 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
- Being tested
- EX, DIET, STRETCH, ED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXBehavioural
Also called Combined aerobic and resistance exercise
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.
DIETBehavioural
Also called Brain-healthy diet education and counseling
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.
STRETCHBehavioural
Also called Stretching and toning exercise
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.
EDBehavioural
Also called Brain Health Education and Discussion
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 group | Role | What they receive |
|---|---|---|
| EX + DIET | Experimental | 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). Receives: Behavioral: EX; Behavioral: DIET |
| EX + ED | Active comparator | 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). Receives: Behavioral: EX; Behavioral: ED |
| STRETCH + DIET | Active comparator | 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). Receives: Behavioral: DIET; Behavioral: STRETCH |
| STRETCH + ED | Placebo comparator | 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) Receives: Behavioral: STRETCH; Behavioral: ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment
Recruitment rate per month
Measured: 6 months
Feasibility: Retention
Percent of consented participants who complete the post-intervention assessment of executive function
Measured: 6 months
Feasibility: Adherence
Percent of study intervention sessions attended by type
Measured: 6 months
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)
Measured: 6 months
Secondary outcomes (18)
Retention by gender
Does retention vary by gender (men, women, other)
Measured: 6 months
Adherence by gender
Does adherence vary by gender (men, women, other)
Measured: 6 months
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.
Measured: 6 months
Memory
a secondary outcome of a future, large scale trial: memory (Rey Auditory verbal Learning Test [RAVLT] immediate and delayed recall)
Measured: 6 months
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])
Measured: 6 months
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)
Measured: 6 months
Physical Function
a secondary outcome of a future, large scale trial: physical function (assessed using a 5 times sit-to-stand test)
Measured: 6 months
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)
Measured: 6 months
Waist Circumference
a secondary outcome of a future, large scale trial: waist circumference
Measured: 6 months
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
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 6 months
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)
Measured: 6 months
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)
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start3 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Baycrest, Université de Montréal, University of Ottawa
- Responsible party
- Principal investigator, Laura Middleton, University of Waterloo
- Investigators
- Laura Middleton, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078748
- Sponsor's protocol ID
- 44616
- Status last verified
- Apr 2025
- First submitted
- 1 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IDP will be uploaded to an open access data repository. The exact repository has yet to be decided. All data will be de-identified.
Publications
Neudorf B, Koblinsky N, Power K, Binns M, Fiocco AJ, Rotenberg S, Marzolini S, Oh P, Thornton J, Ajwani F, Sullivan K, Chevalier S, Russell C, Ferland G, Anderson ND, Middleton LE. Rationale and protocol of the LEAD 2.0 study: a randomized controlled trial assessing the feasibility of a virtually delivered 6-month exercise and nutrition intervention in older adults with subjective cognitive decline (SCD). Pilot Feasibility Stud. 2025 May 10;11(1):64. doi: 10.1186/s40814-025-01626-4.
PubMed 40349092
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lifestyle, Exercise, and Diet Trial: A Virtual, Lifestyle Approach to Improve Cognition
- ClinicalTrials.gov ID
- NCT06078748
- Acronym / sponsor ID
- 44616
- Conditions
- Subjective Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Baycrest, Université de Montréal, University of Ottawa
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Factorial randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EX + DIET | Experimental | Behavioral: EX, Behavioral: DIETParticipants 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 | Active comparator | Behavioral: EX, Behavioral: EDParticipants 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 + DIET | Active comparator | Behavioral: DIET, Behavioral: STRETCHParticipants 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 + ED | Placebo comparator | Behavioral: STRETCH, Behavioral: EDParticipants 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) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 65-80 years old
- Meet criteria for executive SCD
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXAlso: Combined aerobic and resistance exerciseEX 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. | Behavioural | EX + DIET, EX + ED |
| DIETAlso: Brain-healthy diet education and counselingDIET 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. | Behavioural | EX + DIET, STRETCH + DIET |
| STRETCHAlso: Stretching and toning exerciseSTRETCH 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. | Behavioural | STRETCH + DIET, STRETCH + ED |
| EDAlso: Brain Health Education and DiscussionED 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. | Behavioural | EX + ED, STRETCH + ED |
Primary outcome
Feasibility: Recruitment
Time frame: 6 months
Recruitment rate per month
Feasibility: Retention
Time frame: 6 months
Percent of consented participants who complete the post-intervention assessment of executive function
Feasibility: Adherence
Time frame: 6 months
Percent of study intervention sessions attended by type
Feasiliby: Adherence (diet)
Time frame: 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)
18 secondary outcomes
Retention by gender
Time frame: 6 months
Adherence by gender
Time frame: 6 months
Executive Function
Time frame: 6 months
Memory
Time frame: 6 months
Diet
Time frame: 6 months
Physical Activity
Time frame: 6 months
Physical Function
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Waist Circumference
Time frame: 6 months
Maintenance of change in executive function
Time frame: 12 months
Maintenance of diet quality
Time frame: 12 months
Maintenance of physical activity
Time frame: 12 months
Effect modification of executive function by sex
Time frame: 6 months
Effect modification of executive function by gender
Time frame: 6 months
Effect modification of physical activity by sex
Time frame: 12 months
Effect modification of physical activity by gender
Time frame: 12 months
Effective modification of diet quality by sex
Time frame: 12 months
Effective modification of diet quality by gender
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 40349092Neudorf B, Koblinsky N, Power K, Binns M, Fiocco AJ, Rotenberg S, Marzolini S, Oh P, Thornton J, Ajwani F, Sullivan K, Chevalier S, Russell C, Ferland G, Anderson ND, Middleton LE. Rationale and protocol of the LEAD 2.0 study: a randomized controlled trial assessing the feasibility of a virtually delivered 6-month exercise and nutrition intervention in older adults with subjective cognitive decline (SCD). Pilot Feasibility Stud. 2025 May 10;11(1):64. doi: 10.1186/s40814-025-01626-4.
- Individual participant dataSharing planned: Yes. IDP will be uploaded to an open access data repository. The exact repository has yet to be decided. All data will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Middleton, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EX, DIET and STRETCH in people with Subjective Cognitive Decline, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.