The Lifestyle Exercise and Diet Trial (LEAD) 2.0

Last updated: April 2, 2025
Sponsor: University of Waterloo
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Dementia

Memory Problems

Treatment

EX

DIET

ED

Clinical Study ID

NCT06078748
44616
  • Ages 65-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 65-80 years old

  2. Meet criteria for executive SCD

  3. Answer Yes to both following questions:

  • Do you feel like your memory or thinking is becoming worse?
  • Does this worry you?

  1. ≥1SD above age and sex-based means on any of the sub scales of theComprehensive Executive Function Inventory (CEFI) - Adult Version, indicativeof concerns about executive function.

  2. 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

  1. Able to communicate in English

  2. Residents of Quebec, Ontario, Manitoba, and Saskatchewan to facilitate concurrentintervention delivery

  3. Low physical activity levels (<75min/week of moderate/vigorous physical activity onthe Get Active Questionnaire)

  4. Screened safe to participate in moderate exercise using the Get Active Questionnaireor physician approval to engage in moderate intensity exercise without in-personsupervision

  5. Poor diet quality (below Canadian older adults' median intake of fruits, vegetables,nuts and fish, reported using our Diet Screening Questionnaire)

  6. Able to participate remotely (i.e., availability of, or ability/willingness toadopt, a computer or tablet alongside high speed internet/data networks)

Exclusion

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 orassessments

  • Major psychiatric disorder

  • Ongoing alcohol or drug abuse that in the opinion of the investigator may interferewith the subject's ability to comply with the study procedures.

  • Contraindications for exercise as determined by the American College of SportsMedicine criteria

Study Design

Total Participants: 140
Treatment Group(s): 4
Primary Treatment: EX
Phase:
Study Start date:
October 03, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Waterloo

    Waterloo, Ontario 41080
    Canada

    Site Not Available

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