Clinical trial NCT06325306: Physical Literacy-Based Intervention for Chronic Disease Management
Official title: Physical Literacy-Based Intervention for Chronic Disease Management: A Quasi-Experimental Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Chronic Disease Management
Aging
Keywords: Physical literacy
Physical activity
Chronic Disease
quasi-experimental study
health promotion
group sessions
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Liege
First posted: 2024-03-22
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are:

* How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels?
* Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients?

Participants will:

* Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period.
* Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy.

Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes.

Detailed description: The study employs a quasi-experimental design to investigate the impact of physical literacy-based interventions in chronic disease management. Participants are recruited from the Citoyen en mouvement pour ma santé program, designed for adults with chronic diseases in Belgium, facilitating their engagement in adapted physical activity (APA) group sessions. The study structure includes a control group (no intervention), a traditional APA group, and an APA with Physical Literacy (APA+PL) group, each consisting of approximately 65 participants to account for potential dropouts and ensure robust statistical analysis.

The intervention lasts six months, with initial and follow-up assessments at three and six months. These evaluations measure physical literacy dimensions-motivation, confidence, physical competence, knowledge, and engagement-using a combination of questionnaires and physical tests. The assessment tool, inspired by Whitehead's definitions and the IPLA framework, encompasses six core dimensions of physical literacy. It integrates closed-ended questions for quantitative analysis and open-ended questions for qualitative insights, offering a comprehensive view of participants physical literacy journey.

The APA+PL intervention is meticulously planned, following the Physical Literacy Interventions Reporting Template (PLIRT), focusing on enhancing physical literacy through tailored physical activity sessions. These sessions, led by qualified APA educators, are structured to integrate physical literacy elements seamlessly into the exercise routines. The program includes varied physical activities aiming to improve physical fitness (endurance, strength, flexibility, balance) and instill a deeper understanding and appreciation of physical literacy in participants.

The study data analysis plan involves a mixed-methods approach, capturing both the quantitative changes in physical literacy scores and the qualitative experiences of participants. Quantitative data will be analyzed using mixed ANOVA models to evaluate within-subject changes and between-group differences in physical literacy scores. Qualitative data, derived from open-ended questionnaire responses, will undergo thematic analysis to identify recurring themes and insights into the participants experiences and perceptions of the intervention.

Researchers will perform subgroup analyses based on age, gender, and chronic disease type, with adjusted analyses for potential confounders. The study seeks to understand the broader implications of physical literacy interventions in chronic disease management, aiming to inform future public health strategies and promote sustained engagement in physical activities among chronic disease patients.

This comprehensive approach to evaluating physical literacy interventions will contribute significantly to the understanding of how these interventions can be optimized to support chronic disease management in adult populations, potentially guiding future healthcare practices and policies.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older.
* Diagnosed with one or more chronic diseases.
* Possessing a medical clearance to participate in physical activities.
* Enrolled in the Citoyen en mouvement pour ma santé program.
* Willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Individuals younger than 18 years.
* Without a formal diagnosis of a chronic disease.
* Lacking medical clearance for engaging in physical activity.
* Not enrolled in the Citoyen en mouvement pour ma santé program.
* Unable to provide informed consent due to cognitive impairment or other reasons.
* Those who have severe mobility limitations or other health conditions that preclude safe participation in the physical activity sessions as determined by medical assessment.

Primary outcomes:
measure: Global Physical Literacy Score
timeFrame: Baseline, 3 months, and 6 months post-intervention
measure: Physical Activity Behavior and Engagement
timeFrame: Baseline, 3 months, and 6 months post-intervention
measure: Motivation and Confidence in Physical Activity
timeFrame: Time Frame: Baseline, 3 months, and 6 months post-intervention
measure: Physical Competence
timeFrame: Baseline, 3 months, and 6 months post-intervention
measure: Knowledge and Understanding of Physical Activity
timeFrame: Baseline, 3 months, and 6 months post-intervention
measure: Environment interactions
timeFrame: Baseline, 3 months, and 6 months post-intervention
measure: Meaningful and Purposeful Activities
timeFrame: Baseline, 3 months, and 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre Sportif du Sart-Tilman
Study officials:
References: