A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk Factors—the Dalby Lifestyle Intervention Cohort (DALICO) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Region Skane
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01187576
First received: August 23, 2010
Last updated: October 15, 2012
Last verified: October 2012

August 23, 2010
October 15, 2012
November 2010
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01187576 on ClinicalTrials.gov Archive Site
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A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk Factors—the Dalby Lifestyle Intervention Cohort (DALICO) Study
A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk factors-the Dalby Lifestyle Intervention Cohort Study (DALICO) Study

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

- 3 - outcomes of the intervention are extrapolated by economic modelling. The first statistical analyses and compilation of results will be performed one year after inclusion of the first patient or when the IG and CA have included 60 and 30 eligible patients respectively. Discussion 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.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Motivation for Physical Activity
  • Behavioral: Multi-professional team intervention with PAR, lifestyle brochure
    Multi-professional team intervention with PAR, lifestyle brochure
  • Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure
    Ordinary recommendations on health behaviours, lifestyle brochure
  • Experimental: Intervention
    Multi-professional team intervention with PAR, lifestyle brochure
    Intervention: Behavioral: Multi-professional team intervention with PAR, lifestyle brochure
  • Active Comparator: Conventional treatment
    Ordinary recommendations on health behaviours, lifestyle brochure
    Intervention: Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure
  • No Intervention: retrospective med history comparison
    Treatment as usual (retrospective data collection)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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June 2013   (final data collection date for primary outcome measure)

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

  • 13 - diastolic blood pressure ≥ 85 mmHg

Exclusion Criteria:

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Both
18 Years to 95 Years
No
Contact: Rickard W Ekesbo, M.D.,Ph.D. +46 705 476144 rickard.ekesbo@capio.se
Sweden
 
NCT01187576
CPF FaR 001
No
Region Skane
Region Skane
Swedish Council for Working Life and Social Research
Not Provided
Region Skane
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP