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Feasibility and preliminary efficacy of the LEAD trial: a cluster randomized controlled lifestyle intervention to improve hippocampal volume in older adults at-risk for dementia.
Koblinsky, N D; Anderson, N D; Ajwani, F; Parrott, M D; Dawson, D; Marzolini, S; Oh, P; MacIntosh, B; Middleton, L; Ferland, G; Greenwood, C E.
  • Koblinsky ND; Rotman Research Institute, Baycrest Health Sciences, Toronto, Canada.
  • Anderson ND; Rotman Research Institute, Baycrest Health Sciences, Toronto, Canada. nanderson@research.baycrest.org.
  • Ajwani F; Departments of Psychology and Psychiatry, University of Toronto, Toronto, Canada. nanderson@research.baycrest.org.
  • Parrott MD; Rotman Research Institute, Baycrest Health Sciences, Toronto, Canada.
  • Dawson D; KITE, Toronto Rehabilitation Institute - the University Health Network, Toronto, Canada.
  • Marzolini S; PERFORM Centre, Concordia University, Montreal, Canada.
  • Oh P; Rotman Research Institute, Baycrest Health Sciences, Toronto, Canada.
  • MacIntosh B; Department of Occupational Sciences and Occupational Therapy and Rehabilitation Sciences Institute, University of Toronto, Toronto, Canada.
  • Middleton L; KITE, Toronto Rehabilitation Institute - the University Health Network, Toronto, Canada.
  • Ferland G; KITE, Toronto Rehabilitation Institute - the University Health Network, Toronto, Canada.
  • Greenwood CE; Hurvitz Brain Sciences, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.
Pilot Feasibility Stud ; 8(1): 37, 2022 Feb 09.
Article in English | MEDLINE | ID: covidwho-1822217
ABSTRACT

BACKGROUND:

Healthy diet and exercise are associated with reduced risk of dementia in older adults. The impact of diet and exercise interventions on brain health is less consistent, especially with dietary interventions which rely on varying approaches. Our objective was to evaluate the feasibility and preliminary efficacy of a 6-month intervention combining exercise with a novel dietary counseling approach to improve hippocampal volume among older adults at-risk for dementia.

METHODS:

Participants with vascular risk factors and subjective cognitive decline or early mild cognitive impairment were cluster randomized in groups of 3-4 to the diet intervention (DIET) or control education (ED) group. All participants engaged in 1 h of supervised exercise per week and additional exercise at home. DIET involved 1 h per week of group-based dietary counseling comprising education, goal setting, and strategy training. ED involved 1 h per week of group-based brain health education classes. Our primary outcome was change in hippocampal volume from baseline to 6 months. Secondary outcomes included changes in cognitive function, blood biomarkers, diet, and fitness. Recruitment challenges and early discontinuation of the trial due to COVID-19 necessitated a revised focus on feasibility and preliminary efficacy.

RESULTS:

Of 190 older adults contacted, 14 (7%) were eligible and enrolled, constituting 21% of our recruitment target. All participants completed the intervention and attended 90% of exercise and DIET/ED sessions on average. All 6-month assessments prior to COVID-19 were completed but disruptions to in-person testing resulted in incomplete data collection. No serious adverse events occurred and all participants expressed positive feedback about the study. Preliminary findings did not identify any significant changes in hippocampal volume; however, substantial improvements in diet and HbA1c were observed with DIET compared to ED (d = 1.75 and 1.07, respectively).

CONCLUSIONS:

High adherence and retention rates were observed among participants and preliminary findings illustrate improvements in diet quality and HbA1c. These results indicate that a larger trial is feasible if difficulties surrounding recruitment can be mitigated. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT03056508 .
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Pilot Feasibility Stud Year: 2022 Document Type: Article Affiliation country: S40814-022-00977-6

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Pilot Feasibility Stud Year: 2022 Document Type: Article Affiliation country: S40814-022-00977-6