NCT03681002

Brief Summary

The aim of the present study is to describe and evaluate the effect of a structured lifestyle intervention program, focusing on lifestyle habits, in a primary care setting in patients with high cardiovascular risk. Furthermore, we want to explore the patient´s experience of lifestyle change and counseling after participation in the intervention program and to investigate the cost-effectiveness of the program.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

4.9 years

First QC Date

September 18, 2018

Last Update Submit

September 20, 2018

Conditions

Cardiovascular Risk FactorLifestyle Risk ReductionPrimary Care

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity

    Patients rating perceived physical activity on a scale 0-10 at baseline and at 12 months

    From baseline to 12 months

Secondary Outcomes (1)

  • Framingham risk score

    From baseline to 12 months

Study Arms (1)

structured lifestyle program

OTHER

individual counseling focusing on Lifestyle habits

Behavioral: structured lifestyle program

Interventions

structured lifestyle programBEHAVIORAL

Intensive Lifestyle counseling during one year

structured lifestyle program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with
  • hypertension
  • diabetes mellitus type 2
  • impaired glucose tolerance

You may not qualify if:

  • dementia
  • severe psychiatric disease
  • difficulties to understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mattias K Damberg

    Associate professor, Department of Public health and caring sciences; Family medicine and preventive medicin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 21, 2018

Study Start

October 1, 2009

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

September 21, 2018

Record last verified: 2018-09