Clinical trial NCT01163968: Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
Official title: Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight reduction
Cardiac revascularization
Percutaneous Coronary Intervention
Cardiac Rehabilitation
Rural
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2010-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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 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)

Primary outcomes:
measure: Weight reduction
timeFrame: 16 weeks after PCI
measure: Weight reduction
timeFrame: 6 months after PCI
measure: Weight reduction
timeFrame: 9 months after PCI
Secondary outcomes:
measure: Diet behavior
timeFrame: 16 weeks after PCI
measure: Physical Activity behavior
timeFrame: 16 weeks after PCI
measure: Abdominal fat content percent (%) change
timeFrame: 16 weeks after PCI
measure: Diet behavior
timeFrame: 6 months after PCI
measure: Diet behavior
timeFrame: 9 months after PCI
measure: Physical Activity behavior
timeFrame: 6 months after PCI
measure: Physical Activity behavior
timeFrame: 9 months after PCI
measure: Abdominal fat content percent (%) change
timeFrame: 6 months after PCI
measure: Abdominal fat content percent (%) change
timeFrame: 9 months after PCI
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: BryanLGH Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Susan A Barnason, PhD
role: PRINCIPAL_INVESTIGATOR
References: