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)
Abstract Background With 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 imp...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-05-01
|
| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-025-01626-4 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849728373996126208 |
|---|---|
| author | Bobby Neudorf Noah Koblinsky Krista Power Malcom Binns Alexandra J. Fiocco Shlomit Rotenberg Susan Marzolini Paul Oh Jane Thornton Fatim Ajwani Kylie Sullivan Stéphanie Chevalier Caryl Russell Guylaine Ferland Nicole D. Anderson Laura E. Middleton |
| author_facet | Bobby Neudorf Noah Koblinsky Krista Power Malcom Binns Alexandra J. Fiocco Shlomit Rotenberg Susan Marzolini Paul Oh Jane Thornton Fatim Ajwani Kylie Sullivan Stéphanie Chevalier Caryl Russell Guylaine Ferland Nicole D. Anderson Laura E. Middleton |
| author_sort | Bobby Neudorf |
| collection | DOAJ |
| description | Abstract Background With 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. Objective This 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. Methods We 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 registration The 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. |
| format | Article |
| id | doaj-art-3b35f1d72dbe4835a6c44ece06ed1e01 |
| institution | DOAJ |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj-art-3b35f1d72dbe4835a6c44ece06ed1e012025-08-20T03:09:34ZengBMCPilot and Feasibility Studies2055-57842025-05-0111111510.1186/s40814-025-01626-4Rationale 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 Neudorf0Noah Koblinsky1Krista Power2Malcom Binns3Alexandra J. Fiocco4Shlomit Rotenberg5Susan Marzolini6Paul Oh7Jane Thornton8Fatim Ajwani9Kylie Sullivan10Stéphanie Chevalier11Caryl Russell12Guylaine Ferland13Nicole D. Anderson14Laura E. Middleton15Department of Kinesiology, University of WaterlooRotman Research Institute, Baycrest Academy for Research and EducationSchool of Nutrition Sciences, University of OttawaRotman Research Institute, Baycrest Academy for Research and EducationDepartment of Psychology, Toronto Metropolitan UniversityDepartment of Occupational Science and Occupational Therapy, University of TorontoKite Research Institute, University Health Network, Toronto Rehabilitation InstituteKite Research Institute, University Health Network, Toronto Rehabilitation InstituteDepartment of Family Medicine, Schulich School of Medicine and Dentistry, University of Western OntarioKite Research Institute, University Health Network, Toronto Rehabilitation InstituteDepartment of Kinesiology, University of WaterlooSchool of Human Nutrition, Mcgill University and Research Instituteof the, Mcgill University Health Centreaq Department of Kinesiology, University of WaterlooDépartement de Nutrition, Montreal Heart Institute Research Centreand, Université de MontréalRotman Research Institute, Baycrest Academy for Research and EducationDepartment of Kinesiology, University of WaterlooAbstract Background With 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. Objective This 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. Methods We 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 registration The 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.https://doi.org/10.1186/s40814-025-01626-4CognitionExerciseDietFeasibilityRCTVirtual |
| spellingShingle | Bobby Neudorf Noah Koblinsky Krista Power Malcom Binns Alexandra J. Fiocco Shlomit Rotenberg Susan Marzolini Paul Oh Jane Thornton Fatim Ajwani Kylie Sullivan Stéphanie Chevalier Caryl Russell Guylaine Ferland Nicole D. Anderson Laura E. Middleton 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) Pilot and Feasibility Studies Cognition Exercise Diet Feasibility RCT Virtual |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Cognition Exercise Diet Feasibility RCT Virtual |
| url | https://doi.org/10.1186/s40814-025-01626-4 |
| work_keys_str_mv | AT bobbyneudorf rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT noahkoblinsky rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT kristapower rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT malcombinns rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT alexandrajfiocco rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT shlomitrotenberg rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT susanmarzolini rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT pauloh rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT janethornton rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT fatimajwani rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT kyliesullivan rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT stephaniechevalier rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT carylrussell rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT guylaineferland rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT nicoledanderson rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd AT lauraemiddleton rationaleandprotocolofthelead20studyarandomizedcontrolledtrialassessingthefeasibilityofavirtuallydelivered6monthexerciseandnutritioninterventioninolderadultswithsubjectivecognitivedeclinescd |