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Behavioural Intervention

Lifestyle Interventions for Mild Cognitive Impairment

Q: Is this research study accepting older individuals over 45?

This trial is currently enrolling those aged between 65 and 80 years old.

Q: Am I a suitable candidate to take part in the experiment?

In order to qualify for this clinical trial, prospective patients must have <a href="https://www.withpower.com/clinical-trials/mild-cognitive-impairment">mild cognitive impairment</a> and be aged between 65 and 80. The study is currently recruiting approximately 140 participants.

Q: Does this research program have any open slots for participants?

Affirmative. According to the data available on clinicaltrials.gov, this medical trial is actively recruiting participants since it was first posted in October 1st 2023 and updated on October 3rd of the same year. For now, 140 individuals are needed for enrollment at a single site.

Q: How many individuals are engaged in this clinical experiment?

Affirmative. According to the information on clinicaltrials.gov, this medical study is actively seeking volunteers for enrollment. The trial was first made public on October 1st 2023 and has since been updated as of October 3rd 2023. 140 patients need to be sourced from one single location in order for the trial to succeed.

Q: What aims does this experiment seek to accomplish?

This trial, which is anticipated to take 6 months, has a primary aim of assessing participant retention. Other objectives being measured are differences in adherence rates based on gender and executive/memory function as evaluated by Cambridge Brain Sciences online assessments.

N/A

Recruiting

Led By Laura Middleton, PhD

Research Sponsored by University of Waterloo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test an online 6-month exercise and nutrition program to improve memory and thinking abilities in older adults with declining mental function. 140 people aged 65-80 will be recruited and receive different combinations of lifestyle interventions. Assessments will be conducted online and from home.

Who is the study for?

The LEAD 2.0 trial is for adults aged 65-80 in Quebec, Ontario, Manitoba, and Saskatchewan who feel their cognitive abilities are declining but do not have dementia or other severe brain conditions. They should be physically inactive (<75min/week of exercise), have a poor diet, and be able to use a computer with internet for remote participation.Check my eligibility

What is being tested?

This study tests if older adults can stick to a 6-month virtual program focused on exercise and nutrition to improve cognition, physical function, and quality of life. Participants will join one of four groups receiving different combinations of exercises (EX), stretching (STRETCH), dietary changes (DIET), or educational sessions (ED).See study design

What are the potential side effects?

Since the interventions involve lifestyle changes like exercise and diet modifications rather than medications, side effects may include muscle soreness from new physical activities or adjustments in digestion due to dietary changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility: Adherence

Feasibility: Recruitment

Feasibility: Retention

+1 more

Secondary outcome measures

Adherence by gender

Diet

Effect modification of executive function by gender

+15 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: EX + DIETExperimental Treatment2 Interventions

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).

Group II: EX + EDActive Control2 Interventions

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).

Group III: STRETCH + DIETActive Control2 Interventions

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).

Group IV: STRETCH + EDPlacebo Group2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

DIET

2015

N/A

~280

2009

Completed Early Phase 1

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BaycrestOTHER

43 Previous Clinical Trials

5,827 Total Patients Enrolled

University of WaterlooLead Sponsor

124 Previous Clinical Trials

209,218 Total Patients Enrolled

University of OttawaOTHER

208 Previous Clinical Trials

267,016 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study accepting older individuals over 45?

"This trial is currently enrolling those aged between 65 and 80 years old."

Answered by AI

Am I a suitable candidate to take part in the experiment?

"In order to qualify for this clinical trial, prospective patients must have mild cognitive impairment and be aged between 65 and 80. The study is currently recruiting approximately 140 participants."

Answered by AI

Does this research program have any open slots for participants?

"Affirmative. According to the data available on clinicaltrials.gov, this medical trial is actively recruiting participants since it was first posted in October 1st 2023 and updated on October 3rd of the same year. For now, 140 individuals are needed for enrollment at a single site."

Answered by AI

How many individuals are engaged in this clinical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this medical study is actively seeking volunteers for enrollment. The trial was first made public on October 1st 2023 and has since been updated as of October 3rd 2023. 140 patients need to be sourced from one single location in order for the trial to succeed."

Answered by AI

What aims does this experiment seek to accomplish?

"This trial, which is anticipated to take 6 months, has a primary aim of assessing participant retention. Other objectives being measured are differences in adherence rates based on gender and executive/memory function as evaluated by Cambridge Brain Sciences online assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Lifestyle Exercise and Diet Trial (LEAD) 2.0

Laura Middleton 2023. "The Lifestyle Exercise and Diet Trial (LEAD) 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06078748.

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