Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01163968
First received: July 6, 2010
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to examine the use of a home-based program to improve weight reduction after percutaneous coronary intervention (PCI) (either a cardiac stent or angioplasty procedure).


Condition Intervention
Obesity
Behavioral: MOMENTUM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Weight reduction [ Time Frame: 16 weeks after PCI ] [ Designated as safety issue: No ]
  • Weight reduction [ Time Frame: 6 months after PCI ] [ Designated as safety issue: No ]
  • Weight reduction [ Time Frame: 9 months after PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diet behavior [ Time Frame: 16 weeks after PCI ] [ Designated as safety issue: No ]
  • Physical Activity behavior [ Time Frame: 16 weeks after PCI ] [ Designated as safety issue: No ]
  • Abdominal fat content percent (%) change [ Time Frame: 16 weeks after PCI ] [ Designated as safety issue: No ]
  • Diet behavior [ Time Frame: 6 months after PCI ] [ Designated as safety issue: No ]
  • Diet behavior [ Time Frame: 9 months after PCI ] [ Designated as safety issue: No ]
  • Physical Activity behavior [ Time Frame: 6 months after PCI ] [ Designated as safety issue: No ]
  • Physical Activity behavior [ Time Frame: 9 months after PCI ] [ Designated as safety issue: No ]
  • Abdominal fat content percent (%) change [ Time Frame: 6 months after PCI ] [ Designated as safety issue: No ]
  • Abdominal fat content percent (%) change [ Time Frame: 9 months after PCI ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight reduction program
MOMENTUM intervention
Behavioral: MOMENTUM
The Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM) intervention is comprised of 6 modules, totaling 52 daily sessions promoting weight reduction, and 4 coaching sessions over the duration of the 12 week MOMENTUM intervention. The MOMENTUM intervention will be delivered using telehealth methods (Viterion telehealth device will be used to deliver the module content and coaching sessions). The intervention was purposively designed to overcome access barriers by using delivery modes accessible to patients in rural settings, in their home and at times convenient to their schedule.

Detailed Description:

Obesity is an independent risk factor for coronary disease and is prevalent among patients who undergo percutaneous coronary intervention (PCI). The significance of cardiac disease is often underestimated by patients who undergo PCI, and therefore they are more reticent in modifying their cardiac risk factors such as obesity following PCI. This issue is particularly problematic for rural populations, given that weight reduction specific programs are often not available in rural communities. The overall goal of this pilot study is to evaluate a 12 week cognitive behavioral intervention for weight reduction of overweight or obese PCI patients who participate in a rural cardiac rehabilitation (CR) program. The Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM) intervention is comprised of 6 modules, totaling 52 daily sessions promoting weight reduction, and 4 coaching sessions over the duration of the 12 week MOMENTUM intervention. The MOMENTUM intervention will be delivered using telehealth methods (Viterion telehealth device will be used to deliver the module content and the telephone to deliver the coaching sessions). The intervention was purposively designed to overcome access barriers by using delivery modes accessible to patients in rural settings, in their home and at times convenient to their schedule. A randomized, 2-group, repeated measures experimental design will be used. Subjects who have had a PCI, are overweight or obese and enroll in a rural cardiac rehabilitation program will be randomized to either the MOMENTUM group (n=25) and or control group (usual care)(n=25). The primary aim of the study is to compare the differences between the groups on weight reduction (primary outcome), diet behavior and physical activity (secondary outcomes) over time (baseline, 16 weeks, 6 and 9 months after PCI). The second aim of the study is to to evaluate the feasibility of implementing the MOMENTUM intervention for a larger randomized controlled trial. The innovation in this pilot study is the use of technology to deliver a comprehensive cognitive-behavioral weight reduction program to those cardiac patients in rural communities who otherwise might not have access to specific weight reduction programs to improve their cardiac risk profile after an acute cardiac event, such as a PCI.      

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The sample for the proposed study will be 50 overweight or obese adults who have had a PCI who meet the following criteria:

    • planning to participate in cardiac rehabilitation at rural study sites in Saline and Seward counties of Nebraska
    • enrolled within 5 days of PCI procedure
    • oriented to person, place, and time
    • not visually impaired and able to hear
    • have telephone service
    • cardiologist's approval to participate in this study.

Exclusion Criteria:

  • Mental status impairment as determined by a score of > 8 on the Short-Portable Mental Status Questionnaire (SPMSQ)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163968

Contacts
Contact: Susan A Barnason, PhD (402) 472-7359 sbarnaso@unmc.edu
Contact: Lani M Zimmerman, PhD (402) 472-3847 lzimmerm@unmc.edu

Locations
United States, Nebraska
BryanLGH Medical Center Recruiting
Lincoln, Nebraska, United States, 68506
Contact: June Smith, PhD    402-489-0200    jsmith@bryanlgh.org   
Contact: Eric Hoesing, BSN    (402) 489-0200    ehoesing@bryanlgh.org   
Principal Investigator: Susan A Barnason, PhD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Susan A Barnason, PhD University of Nebraska Medical Center College of Nursing
  More Information

No publications provided

Responsible Party: Susan Barnason, UNMC College of Nursing
ClinicalTrials.gov Identifier: NCT01163968     History of Changes
Other Study ID Numbers: 177-09-FB, 1P20NR011404-01
Study First Received: July 6, 2010
Last Updated: July 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Weight reduction
Cardiac revascularization
Percutaneous Coronary Intervention
Cardiac Rehabilitation
Rural

Additional relevant MeSH terms:
Magnesium Salicylate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014