The Lifestyle Exercise and Diet Trial (LEAD) 2.0

University of Waterloo

Status: Active, not recruiting

Conditions: Subjective Cognitive Decline

Treatments: Behavioral: STRETCH; Behavioral: DIET; Behavioral: ED; Behavioral: EX

Study type: Interventional

Funder types: Other

Identifiers

NCT06078748

44616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

140 participants in 4 patient groups, including a placebo group

EX + DIET

Experimental group

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).

Treatment:

Behavioral: EX

Behavioral: DIET

EX + ED

Active Comparator group

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).

Treatment:

Behavioral: EX

Behavioral: ED

STRETCH + DIET

Active Comparator group

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).

Treatment:

Behavioral: DIET

Behavioral: STRETCH

STRETCH + ED

Placebo Comparator group

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)

Treatment:

Behavioral: ED

Behavioral: STRETCH