Evidence map›Paper›PMID 40367102›Full record

Trial reportPloS one2025

A pilot pragmatic randomized controlled trial of a 12-month Healthy Lifestyles Program: A collaborative care model for chronic conditions addressing behavioural change.

Japteg Singh, David Feeny, Rebecca Ganann, John N Lavis, Cynthia Lokker, Lawrence Mbuagbaw, Majdi Qutob, Zainab Samaan, Arielle Sutton, Marjan Walli-Attaei and 2 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Japteg SinghDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0002-8203-0574
David FeenyDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Rebecca GanannSchool of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
John N LavisDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0001-7917-3657
Cynthia LokkerHealth Information Research Unit, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-2436-4290
Lawrence MbuagbawDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Majdi QutobDepartment of Surgery, McMaster University, Hamilton, Ontario, Canada.
Zainab SamaanDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0002-5974-9361
Arielle SuttonMD Program, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Marjan Walli-AttaeiPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
Sarah SmithSt. Joseph's Healthcare Hamilton.
Elizabeth AlvarezDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-2333-0144

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLifestyle 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.

methodsThis 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.

resultsRetention 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.

conclusionThis study demonstrated the feasibility of the HLP with minor modifications recommended for a larger trial and for the intervention.

Indexed as

Health PromotionHealthy LifestyleAdultAgedChronic DiseaseCognitive Behavioral TherapyFemaleHumansMaleMiddle AgedPilot Projects

Identifiers

PMID40367102
PMCPMC12077671

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.