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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 (DALICO)

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ClinicalTrials.gov Identifier: NCT01187576
Recruitment Status : Withdrawn (Never started)
First Posted : August 24, 2010
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Region Skane

Brief Summary:

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 or disease Intervention/treatment Phase
Motivation for Physical Activity Behavioral: Multi-professional team intervention with PAR, lifestyle brochure Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : November 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187576


Locations
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Sweden
Dalby Vårdcentral
Dalby, Sweden
Sponsors and Collaborators
Region Skane
Swedish Council for Working Life and Social Research

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01187576    
Other Study ID Numbers: CPF FaR 001
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Keywords provided by Region Skane:
Physical activity
Hypertension
Diabetes mellitus
Motivational interviewing