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Clinical Trial Summary

The aim of this study is to explore possible predicting factors associated with physical activity (PA) level change in a 6-month period of physical activity on prescription (PAP) treatment. This is done in order to highlight potential predictors important for increased PA-level and to identify which primary care patients who may benefit from the PAP-intervention.

Four hundred forty four patients are included in the study, 27-85 years, physically inactive, having at least one component of the metabolic syndrome (MetS) present and receiving PAP-treatment. Possible predicting factors of PA change at baseline and PA-level at 6-month follow-up are analyzed.


Clinical Trial Description

Aim:

To explore possible predicting factors associated with PA-level change in a 6-month period of PAP-treatment. This is done in order to highlight potential predictors important for increased PA-level and to identify which primary care patients who may benefit from the PAP-intervention.

Methods:

Study design:

This is a longitudinal prospective observational cohort study with a 6-month follow-up of PAP-treatment. The treatment is carried out as part of a daily clinical primary care practice.

Study population:

The 444 patients included in the study, are selected from 15 primary health care centres in Gothenburg, Sweden, and are 27-85 years, physically inactive, having at least one component of the MetS 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 6 months. 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 6-month intervention is individually structured either by revisits or by telephone contacts.

Measurements:

The following measurements are conducted at baseline and the 6-month follow-up: PA-level, self-efficacy expectations, outcome expectations, enjoyment, social support, readiness to change PA, body mass index (BMI), and health related quality of life. Age, sex, social situation, economy, education, and smoking is also measured.

Statistical analysis:

A per-protocol analysis is used. In the predictor analysis, Spearman rank correlation and a univariate regression analysis is used, respectively, to examine the association between possible predicting factors at baseline and PA level at 6-month follow-up. Significant predictors from the regression analysis are dichotomized into positive and negative values, respectively, and a Chi-square test for independence is used in analysing the predictors at baseline to increased PA level at 6-month follow-up. Statistical significance is set at p ≤0.05.

Hypothesis:

It is possible finding predicting factors among the patient´s answers according to self-reported questionnaires for the purpose of identifying responders/non-responders to increased physical activity level at 6 month follow-up of PAP-treatment.

Clinical implication:

Highlighting possible predicting factors to increased PA in an early stage of PAP-intervention, offers the opportunity to support the patient in the behavioural change process and to individualize the PAP-treatment, with the aim to increase physical activity level. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03586011
Study type Observational [Patient Registry]
Source Vastra Gotaland Region
Contact
Status Completed
Phase
Start date January 1, 2010
Completion date May 2, 2019

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