Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
Recruitment status was Recruiting
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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) |
- 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 ]
- 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 |
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| Contact: Susan A Barnason, PhD | (402) 472-7359 | sbarnaso@unmc.edu |
| Contact: Lani M Zimmerman, PhD | (402) 472-3847 | lzimmerm@unmc.edu |
| 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 | |
| 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:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms 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 June 18, 2013