Evidence map›Paper›PMID 40349092›Full record

ArticlePilot and feasibility studies2025

Rationale and protocol of the LEAD 2.0 study: a randomized controlled trial assessing the feasibility of a virtually delivered 6-month exercise and nutrition intervention in older adults with subjective cognitive decline (SCD).

Bobby Neudorf, Noah Koblinsky, Krista Power, Malcom Binns, Alexandra J Fiocco, Shlomit Rotenberg, Susan Marzolini, Paul Oh, Jane Thornton, Fatim Ajwani and 6 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06078748 (The Lifestyle, Exercise, and Diet Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06078748 naactive not recruitingnot on this map

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

TypeinterventionalSponsorUniversity of WaterlooRan2023 to 2025Enrolled140ConditionsSubjective Cognitive DeclineArmsEX, DIET, STRETCH, ED
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Bobby NeudorfDepartment of Kinesiology, University of Waterloo, Waterloo, ON, Canada. bjneudor@uwaterloo.ca.ORCID http://orcid.org/0000-0002-4037-9866
Noah KoblinskyRotman Research Institute, Baycrest Academy for Research and Education, Toronto, ON, Canada.
Krista PowerSchool of Nutrition Sciences, University of Ottawa, Ottawa, ON, Canada.
Malcom BinnsRotman Research Institute, Baycrest Academy for Research and Education, Toronto, ON, Canada.
Alexandra J FioccoDepartment of Psychology, Toronto Metropolitan University, Toronto, ON, Canada.
Shlomit RotenbergDepartment of Occupational Science and Occupational Therapy, University of Toronto, Toronto, ON, Canada.
Susan MarzoliniKite Research Institute, University Health Network, Toronto Rehabilitation Institute, Toronto, ON, Canada.
Paul OhKite Research Institute, University Health Network, Toronto Rehabilitation Institute, Toronto, ON, Canada.
Jane ThorntonDepartment of Family Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada.
Fatim AjwaniKite Research Institute, University Health Network, Toronto Rehabilitation Institute, Toronto, ON, Canada.
Kylie SullivanDepartment of Kinesiology, University of Waterloo, Waterloo, ON, Canada.
Stéphanie ChevalierSchool of Human Nutrition, Mcgill University and Research Instituteof the, Mcgill University Health Centreaq , Montreal, QC, Canada.
Caryl RussellDepartment of Kinesiology, University of Waterloo, Waterloo, ON, Canada.
Guylaine FerlandDépartement de Nutrition, Montreal Heart Institute Research Centreand, Université de Montréal, Montréal, QC, Canada.
Nicole D AndersonRotman Research Institute, Baycrest Academy for Research and Education, Toronto, ON, Canada.
Laura E MiddletonDepartment of Kinesiology, University of Waterloo, Waterloo, ON, Canada.

Funding

CIHR PJT-183915
6 · The paper itself

Abstract

backgroundWith growing prevalence of dementia worldwide, dementia risk reduction is a key interest of the World Health Organization's Global Dementia Action Plan. Subjective cognitive decline (SCD) is a prominent predictor of future dementia diagnosis. Therefore, people with SCD are an important group for dementia prevention intervention. Exercise and healthy diet are associated with a 30-60% decrease in dementia risk in longitudinal studies. Technological advances yield the potential of trials that deliver lifestyle interventions virtually, reaching people in a wide geographical spread. However, the feasibility of large-scale virtual trials still needs to be established.

objectiveThis trial aims to examine the feasibility of a factorial randomized controlled trial exploring a 6-month virtual, exercise and healthy diet intervention. Secondary objectives will examine whether feasibility outcomes vary by gender or technology access.

methodsWe will recruit 140 older adults (65 + years) with SCD, who will receive a combination of Aerobic and Resistance Exercise (EX) or Stretching and Toning (STRETCH) and either Diet Counseling (DIET) or Brain Health Education (ED). Participants will be randomized to four weekly hours of one of four intervention arms: (1) EX and DIET; (2) EX and ED; (3) STRETCH and DIET; or (4) STRETCH and ED. EX will include moderate intensity aerobic and resistance training. DIET will instruct participants in brain healthy food choices. Assessments will be performed virtually at baseline, 6 months (post-intervention), and 12 months. Feasibility will be measured by recruitment rate, adherence, and retention. DISCUSSION: Established feasibility will set the stage for a definitive trial. Feasibility results will also inform future virtual programs/services. In the long-term, if the interventions are feasible and beneficial, this intervention model could scale up and spread quickly to reach at-risk individuals for the purpose of dementia risk reduction.

trial registrationThe Lifestyle, Exercise, and Diet (LEAD 2.0) study is registered with the US National Institutes of Health clinical trials registry (ClinicalTrials.gov identifier NCT06078748). This report complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement.

Indexed as

CognitionDietExerciseFeasibilityRCTVirtual

Identifiers

PMID40349092
PMCPMC12065297

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.