NCT02136758

Brief Summary

This study was a prospective, randomized trial designed to investigate the efficacy of moderate lifestyle modification for improving the clinical status of patients with coronary artery disease or patients with risk factors that promote coronary artery disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

4.2 years

First QC Date

May 8, 2014

Last Update Submit

May 8, 2014

Conditions

Cardiovascular DiseaseCoronary Artery DiseaseHypertensionDiabetesObesity

Keywords

lifestyle modificationdietexercisecardiovascular diseasegene expressionobesity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Change in BMI

    Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Secondary Outcomes (2)

  • Blood Pressure

    Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

  • Blood Lipids

    Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Other Outcomes (1)

  • Exercise Capacity

    Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Study Arms (2)

Lifestyle modification

EXPERIMENTAL

The intervention group participated in individualized therapeutic lifestyle plans to reduce cardiovascular risk. Participants were introduced to factors contributing to cardiovascular disease and met individually with a registered dietitian, exercise physiologist, stress management instructor, and psychologist to learn effective strategies for integrating healthy changes into their current lifestyle.

Behavioral: CRC lifestyle modification program

Usual care controls

NO INTERVENTION

Control group received standard care from their primary physicians, but did not participate in any component of the lifestyle program or receive any information, advice, or counseling regarding healthy lifestyle behaviors.

Interventions

CRC lifestyle modification programBEHAVIORAL

Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.

Lifestyle modification

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family history of CAD (first degree relative)
  • Physician-diagnosed diabetes or stroke
  • Overweight (BMI/=25) or obese (BMI\>/=30)
  • Total cholesterol \>/=200, documented history of hypercholesterolemia, or currently taking lipid lowering medications
  • History of smoking
  • HDL \</=44 mg/dl
  • LDL \>/=130 mg/dl or documented history of hyperlipidemia
  • Elevated triglycerides (\>/=200 mg/dl)
  • Hypertension (systolic blood pressure \>/=130 mmHg, diastolic blood pressure \>/=85 mmHg, documented diagnosis of hypertension, or currently taking antihypertensive medications)
  • Diabetes (fasting glucose \>/=100 mg/dl, physician diagnosis of diabetes/pre-diabetes, or currently taking anti-glycemic medications)
  • Post traumatic stress disorder (PTSD) or at risk for PTSD
  • Insomnia (five hours of sleep per night or less) or sleep apnea

You may not qualify if:

  • Age \<18 years of age
  • Unstable coronary syndromes, refractory congestive heart failure, uncontrolled arrhythmia, or high-grade uncorrected cardiac conduction abnormalities
  • Any contraindication to components to Program, such as physical disabilities precluding stretching and aerobic exercise or medical conditions that preclude consumption of foods essential to Program diet
  • Inability or unwillingness to give consent
  • Significant left main stenosis (\>50%) or ejection fraction \<35% with no revascularization
  • History of substance abuse (including alcohol) without self-certification of abstinence for at least three months
  • Non-ambulatory (bedridden) individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Windber Research Institute

Windber, Pennsylvania, 15963, United States

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseHypertensionDiabetes MellitusObesityMotor Activity

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Darrell L Ellsworth, PhD

    Windber Research Institute

    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

May 8, 2014

First Posted

May 13, 2014

Study Start

April 1, 2009

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

US(1)