An interventional study of Multi-professional team intervention with PAR, lifestyle brochure and Ordinary recommendations on health behaviours, lifestyle brochure in Motivation for Physical Activity, sponsored by Region Skane. Withdrawn at 1 site in Sweden. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-08-09.
Sponsored by Region Skane · Not applicable, Interventional, and Prevention
Background 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 ordinary physical activity recommendations. 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. Methods/Design 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, lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours, lifestyle brochure; 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. 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 instant feed-back on the patients' health status.
Cost-effectiveness of the intervention is evaluated continuously and the intermediate
Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:newly diagnosed type 2 diabetes or hypertension or both and consecutive primary care patients with suspected type 2 diabetes or hypertension will be screened for inclusion. The diagnose criterion for type 2 diabetes in both the Intervention and the Control groups is defined as a 2 x fasting plasma glucose (fP-glu) ≥ 7.0 mmol/l according to WHO guidelines [29]. The diagnose criterion for hypertension is defined as a resting systolic blood pressure ≥ 140 mmHg or a diastolic blood pressure ≥ 90 mmHg. Hypertension is confirmed by a 24-hour ambulatory blood pressure monitoring: a systolic blood pressure ≥ 135 mmHg and/or a
Exclusion Criteria:
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Multi-professional team intervention with PAR, lifestyle brochure
Behavioral: Multi-professional team intervention with PAR, lifestyle brochure
Ordinary recommendations on health behaviours, lifestyle brochure
Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure
Treatment as usual (retrospective data collection)
Multi-professional team intervention with PAR, lifestyle brochure
Ordinary recommendations on health behaviours, lifestyle brochure
to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both.
Time frame: every 6 months
This study is withdrawn, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Region Skane