BryanLGH Medical Center
Lincoln, Nebraska, 68506, United States
NCT Number: NCT01163968
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).
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Not applicable
Lincoln, Nebraska, 68506, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 16 weeks after PCI
Body Weight
Time frame: 6 months after PCI
Body Weight
Time frame: 9 months after PCI
Body Weight
Time frame: 16 weeks after PCI
Heart Healthy Eating Self-Efficacy Scale
Time frame: 16 weeks after PCI
Actigraph: mean levels of moderate activity
Time frame: 16 weeks after PCI
Waist Circumference
Time frame: 6 months after PCI
Heart Healthy Eating Self-Efficacy Scale
Time frame: 9 months after PCI
Heart Healthy Eating Self-Efficacy Scale
Time frame: 6 months after PCI
Actigraph: mean levels of moderate activity
Time frame: 9 months after PCI
Actigraph: mean levels of moderate activity
Time frame: 6 months after PCI
Waist Circumference
Time frame: 9 months after PCI
Waist circumference
University of Nebraska
Other
Acronym: MOMENTUM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00687115
Body Weight, Body Weight Changes
Phoenix, Arizona, United States
View Trial DetailsNCT05184361
Body Weight, Body Weight Changes
Cruz Quebrada, Lisbon District, Portugal
View Trial DetailsNCT05424081
Body Weight, Body Weight Changes
Palo Alto, California, United States
View Trial DetailsNCT05104450
Apnea, Behavior
Seattle, Washington, United States
View Trial Details