Clinical trial NCT06749249: Enjoyment Mediates Long-term Changes in Physical Activity Level in a Physical Activity on Prescription Intervention.
Official title: Enjoyment Mediates Long-term Changes in Physical Activity Level in a Physical Activity on Prescription Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Physical Activity
Metabolic Syndrome
Primary Health Care
Adults
Keywords: Physical activity on prescription
Mediators of physical activity change
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 444
Sex: ALL
Minimum age (years): 27
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included 444 patients, aged 27-85 years, with metabolic risk factors and being insufficiently physically active according to the internationally recommended minimum PA level of 150 min/week. The patients were recruited between 2010 and 2014 from 15 primary health care centres in Gothenburg, Sweden, as a convenience sample after agreeing to participate in the PAP treatment.

Brief summary: A sufficient level of physical activity (PA) positively affects health and longevity. In Swedish healthcare, insufficiently physically active patients are offered physical activity on prescription (PAP) treatment, an individual support to increase physical activity level. This study investigates the influence of possible mediators and factors associated with a PA level change in primary care patients during a 5-year PAP intervention.

The study population includes 444 patients (56% females), aged 27 to 85 years, with metabolic risk factors and being physically inactive. The patients receive individualized PAP-treatment including PA-consultations, agreed PA recommendations with a written prescription, and structured follow-ups. Associations between 10 theoretical important mediators and factors of PA change, measured at 6 occasions, are analysed against PA level at 5 years and PA level change during the 5-year intervention.

Detailed description: Aim:

To investigate the influence of possible mediators and factors associated with a physical activity (PA) level change in primary care patients during a 5-year physical activity on prescription (PAP) intervention.

Study design:

This is a longitudinal prospective observational cohort study with a 5-year follow-up of PAP-treatment. The treatment is carried out as part of a daily clinical primary care practice.

Study population:

The 444 patients (56% females), aged 27 to 85 years, are selected from 15 primary health care centres in Gothenburg, being physically inactive, having at least one component of the metabolic syndrome present and receiving PAP-treatment. The patients have to understand the Swedish language to fill in the questionnaires.

Intervention:

The PAP-treatment is offered by authorized personnel, educated in PA-effects and PAP-intervention and consists of an individual-based dialogue with the patient, an individually tailored recommendation of PA including a written prescription, and customized, structured support during 5 years. The patients health status, previous respectively current PA level, preferences for different physical activities, motivation, self-efficacy and readiness to change PA behavior are evaluated. An agreed individually dosed PA is written down and the support during the 5-year intervention is individually structured either by revisits or by telephone contacts.

Measurements:

The following measurements are conducted on 6 occasions during the 5-year intervention, at baseline and at the 6-month-, 1.5-, 2.5-, 3.5-, and 5-year follow-ups: PA-level, outcome expectations, enjoyment, confidence in readiness to change, self-efficacy, social support, health related quality of life, body mass index (BMI), age and sex.

Statistical analysis:

Differences between baseline and the 5-year follow-up, within the group, are analyzed using the paired sample t-test or Wilcoxon sign-rank test, based on the data level. A change score (PA at 5 year - PA at baseline) of PA is conducted, thereafter associations between theoretical important mediators of PA change (i.e., outcome expectation and confidence at baseline, and enjoyment, self-efficacy, family positive support, friends positive support and family negative support at 5 year) and PA level at 5 years and PA level change are analyzed using a linear regression. In a final step a mediation model of the mediators of PA change: enjoyment, self-efficacy, and social support and PA level at 5 years and PA level change is conducted using the lavaan package in RStudio version 1.4.1106.

Eligibility criteria: Inclusion Criteria:

* Physically inactive according to ACSM/AHA public health recommendation from 2007.

Having at least one component of the metS present according to the National Cholesterol Education Program (NCEP) classification.

Receiving PAP-treatment. Understanding the Swedish language.

Exclusion Criteria:

* The patient decline to participate.

Primary outcomes:
measure: Change in self-reported PA-level according to the public health recommendation.
timeFrame: From enrollment to the end of treatment at 5 years.
Secondary outcomes:
measure: Outcome expectations - Outcome Expectations for Exercise-2 Scale (OEE-2)
timeFrame: From enrollment to the end of treatment at 5 years
measure: Enjoyment - Physical Activity Enjoyment Scale (PACES)
timeFrame: From enrollment to the end of treatment at 5 years.
measure: Confidence in readiness to change
timeFrame: From enrollment to the end of treatment at 5 years.
measure: Self-efficacy expectations - Self-Efficacy for Exercise Scale (SEE)
timeFrame: From enrollment to the end of treatment at 5 years.
measure: Social support - Social support for exercise scale (SSES)
timeFrame: From enrollment to the end of treatment at 5 years.
measure: Health related quality of life - the Swedish version of the Short Form 36 (SF-36 Standard Swedish Version 1.0)
timeFrame: From enrollment to the end of treatment at 5 years.
measure: Body mass index - BMI
timeFrame: From enrollment to the end of treatment at 5 years.
Other outcomes:
measure: Socio demographic data.
timeFrame: From enrollment to the end of treatment at 5 years.
Locations:
Study officials:
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