NCT01741428

Brief Summary

Early interventions to promote physical activity, dietary lifestyle changes and optimal medication for cardiovascular risk factor reduction - 3 years follow-up. A randomized Clinical Trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
701

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

6.3 years

First QC Date

November 30, 2012

Last Update Submit

February 26, 2020

Conditions

Cardiovascular Disease

Keywords

CVD Risk scorePhysical activityOverweightCholesterolLDL-CholesterolHDL-CholesterolTriglyceridesHbA1CQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in risk score (NORRISK)

    Major End Point Change in risk score (Norrisk, Procam and Framingham) between baseline and after three years of intervention.

    3 Years after end of inclusion

Secondary Outcomes (5)

  • Weight and Body Mass Index (BMI)

    3 Years after end of inclusion

  • Waist circumference

    3 Years after end of inclusion

  • Serum Lipids

    3 Years after end of inclusion

  • Blood Pressure

    3 Years after end of inclusion

  • HbA1C

    3 Years after end of inclusion

Other Outcomes (1)

  • Interaction outcome

    3 Years after end of inclusion

Study Arms (4)

Intervention (INT1)

ACTIVE COMPARATOR

The participants will join a 5-days course at the Feiring Heart Clinic.

Behavioral: Intervention (INT1)

Control (KTR1)

NO INTERVENTION

The participants in the Control Group will receive care as usual at their local Doctors Office

Subgroup Intervention (INT2)

ACTIVE COMPARATOR

Subgroup of 200 participants from the (INT1)where multiple, known CVD risk factors are studied: Physical Activity, Physical Condition (O2-consumption), Quality of life, Biochemical markers (fasting Glucose, Insulin, Apo Lipoprotein A (ApoA), Apo Lipoprotein B (ApoB), micro-C reactive protein (CRP), Total-, LDL- and HDL-cholesterol, Triglycerides and HbA1C.

Behavioral: Intervention (INT1)

Subgroup control (KTR2)

NO INTERVENTION

Subgroup of 200 participants from the (KTR1)where multiple, known CVD risk factors are studied: Physical Activity, Physical Condition (O2-consumption), Quality of life, Biochemical markers (fasting Glucose, Insulin, Apo Lipoprotein A (ApoA), Apo Lipoprotein B (ApoB), micro-C reactive protein (CRP), Total-, LDL- and HDL-cholesterol, Triglycerides and HbA1C.

Interventions

Intervention (INT1)BEHAVIORAL

The course Program at the Feiring Heart Clinic will: Clinical examination and ergospirometric testing, optimizing both treatment and prophylactic medication. Promoting physical Activity, changes in lifestyle, dietary changes/weight reduction, smoking cessation. In the follow-up period the participants will be contacted and report regularly through a web-based secure program (MedAxess)(such as: Activity-, dietary- and smoking habits). Each participant will have their own Mentor, helping keeping up the motivation. They will also meet regularly at the local doctors Office which reports relevant parameters to the Project (such as weight, BP, Lipoproteins, blood glucose/HbA1C)

Intervention (INT1)Subgroup Intervention (INT2)

Eligibility Criteria

Age35 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 0.5% for persons under the age of 50 years
  • \>= 2.5% for persons between 50-59 years
  • \>= 5% for persons \> 60 years

You may not qualify if:

  • Previous cardiovascular disease (CHD ; peripherical atherosclerosis, deep venous thrombosis /pulmonary embolism, congenital heart disease, presence of valvular heart disease).
  • Lung disease restricting usual physical activity .
  • Serious psychological problems (that hinders the participation in the study)
  • All kind of disease restricting performing adequate physical activity .
  • Presence of cancer shortening drastically survival.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-Hospital Gardermoen

Jessheim, N-2051, Norway

Location

Related Publications (9)

  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PMID: 15364185BACKGROUND

  • Artinian NT, Fletcher GF, Mozaffarian D, Kris-Etherton P, Van Horn L, Lichtenstein AH, Kumanyika S, Kraus WE, Fleg JL, Redeker NS, Meininger JC, Banks J, Stuart-Shor EM, Fletcher BJ, Miller TD, Hughes S, Braun LT, Kopin LA, Berra K, Hayman LL, Ewing LJ, Ades PA, Durstine JL, Houston-Miller N, Burke LE; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing. Interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 27;122(4):406-41. doi: 10.1161/CIR.0b013e3181e8edf1. Epub 2010 Jul 12. No abstract available.

    PMID: 20625115BACKGROUND

  • Selmer R, Lindman AS, Tverdal A, Pedersen JI, Njolstad I, Veierod MB. [Model for estimation of cardiovascular risk in Norway]. Tidsskr Nor Laegeforen. 2008 Jan 31;128(3):286-90. Norwegian.

    PMID: 18264151BACKGROUND

  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

    PMID: 11333990BACKGROUND

  • Mattila R, Malmivaara A, Kastarinen M, Kivela SL, Nissinen A. Effectiveness of multidisciplinary lifestyle intervention for hypertension: a randomised controlled trial. J Hum Hypertens. 2003 Mar;17(3):199-205. doi: 10.1038/sj.jhh.1001531.

    PMID: 12624611BACKGROUND

  • Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Am J Prev Med. 2008 Oct;35(4):357-63. doi: 10.1016/j.amepre.2008.06.035.

    PMID: 18779029BACKGROUND

  • Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

    PMID: 11323066BACKGROUND

  • Bergum H, Grimsmo J, Anderssen SA, Klemsdal TO. Effects on physical activity, physical fitness and well-being in a 36-months randomized controlled study, comparing a multimodal hospital-based intervention programme for primary cardiovascular prevention with usual care. BMC Cardiovasc Disord. 2024 Apr 25;24(1):225. doi: 10.1186/s12872-024-03892-1.

    PMID: 38664620DERIVED

  • Bergum H, Sandven I, Abdelnoor M, Anderssen SA, Grimsmo J, Rivrud DE, Myhr NE, Vold MB, Stenbakken C, Lidfors B, Dufseth L, Klemsdal TO. Randomized trial of cardiovascular prevention in Norway combining an in-hospital lifestyle course with primary care follow-up: the Hjerteloftet study. Eur J Prev Cardiol. 2022 Dec 7;29(17):2252-2263. doi: 10.1093/eurjpc/zwac211.

    PMID: 36124709DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMotor ActivityOverweight

Interventions

Methods

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Hilde Bergum, MD

    LHL Hospital Gardermoen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

February 6, 2019

Study Completion

February 6, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

NO(1)