Clinical trial NCT06078748: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Baycrest
name: Université de Montréal
name: University of Ottawa
First posted: 2023-10-12
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: Feasibility: Recruitment
timeFrame: 6 months
measure: Feasibility: Retention
timeFrame: 6 months
measure: Feasibility: Adherence
timeFrame: 6 months
measure: Feasiliby: Adherence (diet)
timeFrame: 6 months
Secondary outcomes:
measure: Retention by gender
timeFrame: 6 months
measure: Adherence by gender
timeFrame: 6 months
measure: Executive Function
timeFrame: 6 months
measure: Memory
timeFrame: 6 months
measure: Diet
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
measure: Physical Function
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
measure: Waist Circumference
timeFrame: 6 months
measure: Maintenance of change in executive function
timeFrame: 12 months
measure: Maintenance of diet quality
timeFrame: 12 months
measure: Maintenance of physical activity
timeFrame: 12 months
measure: Effect modification of executive function by sex
timeFrame: 6 months
measure: Effect modification of executive function by gender
timeFrame: 6 months
measure: Effect modification of physical activity by sex
timeFrame: 12 months
measure: Effect modification of physical activity by gender
timeFrame: 12 months
measure: Effective modification of diet quality by sex
timeFrame: 12 months
measure: Effective modification of diet quality by gender
timeFrame: 12 months
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Laura Middleton, PhD
role: PRINCIPAL_INVESTIGATOR
References: