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
  Purpose

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.


Condition Intervention
Motivation for Physical Activity
Behavioral: Multi-professional team intervention with PAR, lifestyle brochure
Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Multi-professional team intervention with PAR, lifestyle brochure
Behavioral: Multi-professional team intervention with PAR, lifestyle brochure
Multi-professional team intervention with PAR, lifestyle brochure
Active Comparator: Conventional treatment
Ordinary recommendations on health behaviours, lifestyle brochure
Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure
Ordinary recommendations on health behaviours, lifestyle brochure
No Intervention: retrospective med history comparison
Treatment as usual (retrospective data collection)

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187576

Contacts
Contact: Rickard W Ekesbo, M.D.,Ph.D. +46 705 476144 rickard.ekesbo@capio.se

Locations
Sweden
Dalby Vårdcentral Recruiting
Dalby, Sweden
Contact: Rickard W Ekesbo         
Sponsors and Collaborators
Region Skane
Swedish Council for Working Life and Social Research
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01187576     History of Changes
Other Study ID Numbers: CPF FaR 001
Study First Received: August 23, 2010
Last Updated: October 15, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Physical activity
Hypertension
Diabetes mellitus
Motivational interviewing

ClinicalTrials.gov processed this record on September 30, 2014