A pilot pragmatic randomized controlled trial of a 12-month Healthy Lifestyles Program: A collaborative care model for chronic conditions addressing behavioural change
Bibliographic record
Abstract
BACKGROUND: Lifestyle or behavioural changes can help to address the burden associated with chronic diseases. However, they take time and use of multiple techniques or strategies tailored to a person's needs. The primary objective of this study was to assess the feasibility of the Healthy Lifestyles Program (HLP), a novel 12-month complex intervention based in cognitive behavioural therapy and theories of behaviour change, delivered in a community-based setting in Hamilton, Canada. The secondary objective of the study was to explore implementation factors of the HLP. METHODS: This pilot pragmatic randomised controlled trial used quantitative and qualitative evaluation methods. Participants were randomly allocated to either intervention group (n = 15) or comparator group (n = 15). The intervention group attended weekly group education sessions and met with the program intervention team monthly to create and review personalized health goals and action plans. The comparator group met with a trained research assistant every three months to develop health goals and action plans. We assessed program feasibility by measuring recruitment, participation and retention rates, missing data, and attendance. Implementation was assessed in accordance with the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Participant-directed and clinical outcome measures were analyzed for between and within group changes using Generalized Estimating Equations (GEE). Thematic analysis was conducted for qualitative data. RESULTS: Retention rate was 60% (9/15) for the intervention group and 47% (7/15) for the comparator group. Less than 1% of participant-directed and clinical outcomes were missing for those that completed the study. Participants attended an average of 29 of 43 educational sessions and 100% of one-to-one sessions. The program intervention team valued the holistic approach to care, increased time and interaction with participants, professional collaboration, and the ability to provide counselling and health support. Location accessibility was an important factor facilitating implementation. Reducing the number of psycho-social education sessions and having access to a gym could improve retention and program delivery for a larger trial. CONCLUSION: This study demonstrated the feasibility of the HLP with minor modifications recommended for a larger trial and for the intervention.
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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 | 0.012 | 0.021 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
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".