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The online version of this article (doi:10.1186/1472-6963-12-173) contains supplementary material, which is available to authorized users.
Emelie Stenman, Matti E Leijon contributed equally to this work.
The authors declare that they have no competing interests.
RE (MD, PhD and head of Dalby Health Care Centre) introduced the idea and initiated this study. Research Coordinator and Biologist ES (PhD), Research Coordinator Public Health specialist ML (PhD), Psychologist CB, Public Health Nutritionist DA (PhD) and the Family Physicians KS (MD, PhD), SC (MD, PhD), and RE formulated the aim of the study and set up the study logistics. ES drafted the present study protocol. ML coordinated and drafted the study questionnaire. Health Economist UG (PhD) introduced the health economic aspects of the project. All authors contributed to developing the project and all authors read, commented and approved the final version of the manuscript.
The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than physical activity prescription in usual care. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes. Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness.
The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, 2) Control group A (CA): physical activity prescription in usual care and 3) Control group B: treatment as usual (retrospective data collection). The intervention is based on self-determination theory and follows the principles of motivational interviewing. The primary outcome, physical activity, is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides feed-back to the health-care providers on the patients’ health status. Cost-effectiveness of the intervention is evaluated continuously and the intermediate outcomes of the intervention are extrapolated by economic modelling.
By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication.