Recruitment and Baseline Characteristics for the Lifestyle, Exercise and Diet (LEAD) 2.0 Trial: A 6‐month randomized controlled trial of virtual exercise and nutrition interventions in older adults with subjective cognitive decline
Bibliographic record
Abstract
BACKGROUND: The aim of the LEAD 2.0 Trial is to understand whether a 6-month online exercise and diet intervention is feasible among older adults at risk for dementia. Here we describe preliminary data on recruitment feasibility and baseline characteristics of LEAD 2.0 participants. METHOD: The LEAD 2.0 Trial is a 6-month factorial, randomized controlled trial among older adults with subjective cognitive decline (SCD). Feasibility will be evaluated based on recruitment (target: 9 participants/month), adherence (target: 75% of sessions attended), and retention (target: 80% of participants complete 6-month assessment). The exercise intervention included two virtual, group sessions and one independent, pre-recorded video session each week. The diet intervention included one weekly session of healthy diet counselling with goal setting. Stretch and brain education served as time/frequency/social matched controls for exercise and diet counselling interventions respectively. Assessments at baseline, 6 months, and 12 months were also conducted virtually. RESULT: A total of 574 participants were screened from July 2023 to November 2024, with the greatest proportion responding through targeted e-blasts through ZoomerMedia Limited (46.9%), research participant databases (12.2%), and participant referrals (8.4%). Of those sources, the highest portion of eligible individuals came from research participant databases (45.7%), promotion through local/provincial/national organizations (37.5%), and participant referrals (31.3%). Of 574 individuals screened, 236 passed lifestyle screening, 167 passed cognitive screening, and 146 were randomized (9.1 recruited per month). Eligibility was expanded from executive SCD to all SCD after one month of recruitment. Average age of participants was 72.5 ± 5.2 years, 80.8% were female, 85.6% were White, 88.4% had a college/university degree or greater, 61.6% were married, and 79.5% were retired. CONCLUSION: Recruitment to the LEAD 2.0 Trial occurred at target rates using a broad range of recruitment avenues. Targeted e-blasts produced the largest number of participants screened, while research participant databases produced the greatest recruitment yield. Men, people of minority ethno-cultural groups, and people with low education remain under-represented.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.017 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".