Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-04 @ 11:48 AM
Study NCT ID:
NCT03681002
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Structured Lifestyle Program in Primary Care. Changes in Lifestyle Habits and Cardiovascular Risk.
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
Implementation of a Structured Lifestyle Program in a Primary Care Setting. Changes in Lifestyle and Effects on Cardiovascular Risk in Patients With High Cardiovascular Risk.
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Intervention The intervention program comprises five individual visits to the same nurse, specialised in diabetes care and the metabolic syndrome every three month during one year. The nurse led a person centered dialog based on the answers from a questionnaire. At every visit, focus was primarily on lifestyle habits, using motivational interviewing to strengthen the patient's ability to modify one or more lifestyle habits. Dietary counselling was in accordance with the Swedish recommendation in nutrition. If the patient were in need of extended counseling regarding one or more lifestyle habits, he or she could be referred within the primary care unit to a specialist. During the 12-month period, all patients where offered to participate in evening group sessions at three different occasions. Topics were physical activity, fatty acids, healthy food, tobacco and alcohol, stress, sleep and methods of how to change behavior".
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: