Singh Japteg, Feeny David, Ganann Rebecca, Lavis John N, Lokker Cynthia, Mbuagbaw Lawrence, Qutob Majdi, Samaan Zainab, Sutton Arielle, Walli-Attaei Marjan, Smith Sarah, Alvarez Elizabeth
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
PLoS One. 2025 May 14;20(5):e0322118. doi: 10.1371/journal.pone.0322118. eCollection 2025.
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.
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.
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.
This study demonstrated the feasibility of the HLP with minor modifications recommended for a larger trial and for the intervention.
生活方式或行为改变有助于应对与慢性病相关的负担。然而，这些改变需要时间，且需运用多种根据个人需求量身定制的技巧或策略。本研究的主要目的是评估健康生活方式项目（HLP）的可行性，该项目是一项基于认知行为疗法和行为改变理论的为期12个月的新型综合干预措施，在加拿大汉密尔顿的社区环境中实施。本研究的次要目的是探索HLP的实施因素。
这项试点实用随机对照试验采用了定量和定性评估方法。参与者被随机分配到干预组（n = 15）或对照组（n = 15）。干预组每周参加小组教育课程，并每月与项目干预团队会面，以制定和审查个性化的健康目标及行动计划。对照组每三个月与一名经过培训的研究助理会面，以制定健康目标和行动计划。我们通过测量招募率、参与率和留存率、缺失数据以及出勤率来评估项目的可行性。根据“覆盖、效果、采纳、实施、维持”（RE-AIM）框架对实施情况进行评估。使用广义估计方程（GEE）分析参与者主导的和临床结局指标在组间和组内的变化。对定性数据进行主题分析。
干预组的留存率为60%（9/15），对照组为47%（7/15）。完成研究的参与者中，参与者主导的和临床结局指标的缺失率不到1%。参与者平均参加了43次教育课程中的29次以及100%的一对一课程。项目干预团队重视整体护理方法、增加与参与者的时间和互动、专业协作以及提供咨询和健康支持的能力。地点的可达性是促进实施的一个重要因素。减少心理社会教育课程的数量并提供健身房设施，可能会提高留存率并改善更大规模试验的项目实施情况。
本研究证明了HLP的可行性，并为更大规模试验和干预提出了一些小的改进建议。
