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

NCT ID: NCT01187576

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Motivation for Physical Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Multi-professional team intervention with PAR, lifestyle brochure

Group Type EXPERIMENTAL

Multi-professional team intervention with PAR, lifestyle brochure

Intervention Type BEHAVIORAL

Multi-professional team intervention with PAR, lifestyle brochure

Conventional treatment

Ordinary recommendations on health behaviours, lifestyle brochure

Group Type ACTIVE_COMPARATOR

Ordinary recommendations on health behaviours, lifestyle brochure

Intervention Type BEHAVIORAL

Ordinary recommendations on health behaviours, lifestyle brochure

retrospective med history comparison

Treatment as usual (retrospective data collection)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multi-professional team intervention with PAR, lifestyle brochure

Multi-professional team intervention with PAR, lifestyle brochure

Intervention Type BEHAVIORAL

Ordinary recommendations on health behaviours, lifestyle brochure

Ordinary recommendations on health behaviours, lifestyle brochure

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 13 - diastolic blood pressure ≥ 85 mmHg

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dalby Vårdcentral

Dalby, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CPF FaR 001

Identifier Type: -

Identifier Source: org_study_id

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