Feasibility and Preliminary Efficacy of the Lifestyle, Exercise and Diet (LEAD) Study: A Cluster Randomized Controlled Trial of a Combined Exercise and Diet Intervention in Older Adults with Vascular Risk Factors and Early Dementia Risk
Notice bibliographique
Résumé
Abstract Background: Healthy diet and exercise are associated with reduced risk of dementia in older adults. Evidence for the impact of clinical trials on brain health is less consistent, especially with dietary interventions which often rely on varying intervention approaches. Our objective was to evaluate the feasibility and preliminary efficacy of a 6-month intervention combining exercise with a novel dietary counselling approach among older adults with vascular risk factors (VRFs) and early dementia risk. Methods: Participants with VRF’s and SCD or early MCI were cluster randomized into the intervention (exercise + Baycrest Brain-healthy Eating Approach (EX+DIET)) or control group (exercise + brain health education (EX+ED)). Both groups participated in 1-hour of supervised exercise per week and were prescribed additional exercise at home. EX+DIET involved 1-hour per week of group-based dietary counselling comprising didactic education focused on brain healthy eating recommendations, goal setting and strategy training. Whereas, EX+ED involved 1-hour per week of group-based brain health education. The primary outcome was change in hippocampal volume from baseline to 6 months. Secondary outcomes included fitness, diet, cognition, and blood biomarkers. 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 randomized, constituting 21% of our recruitment target. All participants completed the intervention and attended 90% of exercise and diet/education sessions on average. All 6-month follow-up assessments pre-COVID-19 were completed but disruptions to testing during the pandemic resulted in incomplete data collection. No serious adverse events occurred and all participants expressed positive feedback about the intervention. Mean improvements in peak oxygen consumption were observed in both EX+DIET (d = .98) and EX+ED (d =1.15) groups. Substantial improvements in diet and HbA1c were observed in the EX+DIET group compared to EX+ED (d = 1.75 and 1.07, respectively). Conclusions: High adherence and retention rates were observed among LEAD participants and preliminary findings illustrate improvements in cardiorespiratory fitness and diet quality. These results indicate that a larger trial is feasible if difficulties surrounding recruitment can be mitigated. Trial Registration: ClinicalTrials.gov identifier: NCT03056508
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».