NCT02744157

Brief Summary

The aim of the present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

March 3, 2016

Last Update Submit

April 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular risk

    change from baseline in waist circumference after one year

    change from baseline in waist circumference after one year

Study Arms (1)

structured lifestyle program

OTHER

The program consisted of an individual visit to a nurse for a health check-up and lifestyle counseling at baseline, six month and one year. The program also consisted of five group educations which included lectures on nicotine, alcohol, physical inactivity, eating habits, stress, sleeping habits and behavior changes

Behavioral: Longterm effects after a structured lifestyle program

Interventions

present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.

structured lifestyle program

Eligibility Criteria

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

You may qualify if:

  • (three risk factors )
  • cardiovascular disease
  • physical inactivity
  • smoking
  • risk consumption of alcohol
  • unhealthy food habits
  • stress
  • overweight or abdominal obesity
  • high lipids (cholesterol, LDL)
  • high blood pressure
  • diabetes/insulin resistance.

You may not qualify if:

  • Not understand Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lidin M, Hellenius ML, Rydell-Karlsson M, Ekblom-Bak E. Long-term effects on cardiovascular risk of a structured multidisciplinary lifestyle program in clinical practice. BMC Cardiovasc Disord. 2018 Apr 2;18(1):59. doi: 10.1186/s12872-018-0792-6.

Study Officials

  • Mai-Lis Hellenius, Professor

    Karolinska Institutet, Department of medicine and Karolinska University Hospital,Department of Cardiology

    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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2016

First Posted

April 20, 2016

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

December 1, 2014

Last Updated

April 20, 2016

Record last verified: 2016-04