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

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ClinicalTrials.gov Identifier: NCT01163968
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Susan Barnason, PhD, University of Nebraska

July 6, 2010
July 16, 2010
December 8, 2014
June 2010
March 2013   (Final data collection date for primary outcome measure)
  • Weight reduction [ Time Frame: 16 weeks after PCI ]
  • Weight reduction [ Time Frame: 6 months after PCI ]
  • Weight reduction [ Time Frame: 9 months after PCI ]
Same as current
Complete list of historical versions of study NCT01163968 on ClinicalTrials.gov Archive Site
  • Diet behavior [ Time Frame: 16 weeks after PCI ]
  • Physical Activity behavior [ Time Frame: 16 weeks after PCI ]
  • Abdominal fat content percent (%) change [ Time Frame: 16 weeks after PCI ]
  • Diet behavior [ Time Frame: 6 months after PCI ]
  • Diet behavior [ Time Frame: 9 months after PCI ]
  • Physical Activity behavior [ Time Frame: 6 months after PCI ]
  • Physical Activity behavior [ Time Frame: 9 months after PCI ]
  • Abdominal fat content percent (%) change [ Time Frame: 6 months after PCI ]
  • Abdominal fat content percent (%) change [ Time Frame: 9 months after PCI ]
Same as current
Not Provided
Not Provided
 
Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
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).
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
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.
Experimental: Weight reduction program
MOMENTUM intervention
Intervention: Behavioral: MOMENTUM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
March 2013
March 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01163968
177-09-FB
1P20NR011404-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Susan Barnason, PhD, University of Nebraska
University of Nebraska
National Institute of Nursing Research (NINR)
Principal Investigator: Susan A Barnason, PhD University of Nebraska Medical Center College of Nursing
University of Nebraska
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP