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

NCT01187576 | Withdrawn

• 1 other identifier: CPF FaR 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Motivation for Physical Activity

Keywords

Physical activity; Hypertension; Diabetes mellitus; Motivational interviewing

Outcome Measures

Primary Outcomes (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.

  every 6 months

Study Arms (3)

Intervention

EXPERIMENTAL

Multi-professional team intervention with PAR, lifestyle brochure

Behavioral: Multi-professional team intervention with PAR, lifestyle brochure

Conventional treatment

ACTIVE COMPARATOR

Ordinary recommendations on health behaviours, lifestyle brochure

Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure

retrospective med history comparison

NO INTERVENTION

Treatment as usual (retrospective data collection)

Interventions

Multi-professional team intervention with PAR, lifestyle brochure BEHAVIORAL

Multi-professional team intervention with PAR, lifestyle brochure

Intervention

Ordinary recommendations on health behaviours, lifestyle brochure BEHAVIORAL

Ordinary recommendations on health behaviours, lifestyle brochure

Conventional treatment

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diastolic blood pressure ≥ 85 mmHg

Sponsors & Collaborators

• Region Skane: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

Dalby Vårdcentral

Dalby, Sweden

Location

MeSH Terms

Conditions

Motor Activity; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 24, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

SE (1)