๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-02

The Lifestyle Exercise and Diet Trial (LEAD) 2.0 (NCT06078748)

The Lifestyle, Exercise, and Diet Trial: A Virtual, Lifestyle Approach to Improve Cognition

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: University of Waterloo

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Waterloo โ€” Waterloo, Ontario

Age range: 65 Years to 80 Years

๐Ÿงช Interventions in This Study

  • EX (BEHAVIORAL)
  • DIET (BEHAVIORAL)
  • STRETCH (BEHAVIORAL)
  • ED (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of Waterloo โ€” Waterloo, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—