The Lifestyle Exercise and Diet Trial (LEAD) 2.0

NCT06078748 | Active Not Recruiting

• 1 other identifier: 44616
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Cognitive Decline

Outcome Measures

Primary Outcomes (4)

• Feasibility: Recruitment

  Recruitment rate per month

  6 months

• Feasibility: Retention

  Percent of consented participants who complete the post-intervention assessment of executive function

  6 months

• Feasibility: Adherence

  Percent of study intervention sessions attended by type

  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)

  6 months

Secondary Outcomes (18)

• Retention by gender

  6 months

• Adherence by gender

  6 months

• Executive Function

  6 months

• Memory

  6 months

• Diet

  6 months

Study Arms (4)

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).

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).

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).

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)

Behavioral: STRETCH; Behavioral: ED

Interventions

EX BEHAVIORAL

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.

Also known as: Combined aerobic and resistance exercise

EX + DIET; EX + ED

DIET BEHAVIORAL

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.

Also known as: Brain-healthy diet education and counseling

EX + DIET; STRETCH + DIET

STRETCH BEHAVIORAL

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.

Also known as: Stretching and toning exercise

STRETCH + DIET; STRETCH + ED

ED BEHAVIORAL

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.

Also known as: Brain Health Education and Discussion

EX + ED; STRETCH + ED

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Waterloo: lead
• Baycrest: collaborator
• Université de Montréal: collaborator
• University of Ottawa: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, 41080, Canada

Location

Related Publications (1)

• 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.

  PMID: 40349092 DERIVED

MeSH Terms

Interventions

Diet; Counseling

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laura Middleton, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Factorial randomized controlled trial

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: October 12, 2023
• Study Start: October 3, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Open access

Locations

CA (1)