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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01163968
Acronym
MOMENTUM
Enrollment
50
Registered
2010-07-16
Start date
2010-06-01
Completion date
2013-03-04
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight reduction, Cardiac revascularization, Percutaneous Coronary Intervention, Cardiac Rehabilitation, Rural

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.

Interventions

BEHAVIORALMOMENTUM

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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Nebraska
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Weight reduction16 weeks after PCIBody Weight

Secondary

MeasureTime frameDescription
Diet behavior16 weeks after PCIHeart Healthy Eating Self-Efficacy Scale
Physical Activity behavior16 weeks after PCIActigraph: mean levels of moderate activity
Abdominal fat content percent (%) change16 weeks after PCIWaist Circumference

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026