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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: MOMENTUM

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • BryanLGH Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction	Body Weight	16 weeks after PCI
Weight reduction	Body Weight	6 months after PCI
Weight reduction	Body Weight	9 months after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet behavior	Heart Healthy Eating Self-Efficacy Scale	16 weeks after PCI
Physical Activity behavior	Actigraph: mean levels of moderate activity	16 weeks after PCI
Abdominal fat content percent (%) change	Waist Circumference	16 weeks after PCI
Diet behavior	Heart Healthy Eating Self-Efficacy Scale	6 months after PCI
Diet behavior	Heart Healthy Eating Self-Efficacy Scale	9 months after PCI
Physical Activity behavior	Actigraph: mean levels of moderate activity	6 months after PCI
Physical Activity behavior	Actigraph: mean levels of moderate activity	9 months after PCI
Abdominal fat content percent (%) change	Waist Circumference	6 months after PCI
Abdominal fat content percent (%) change	Waist circumference	9 months after PCI

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Susan A Barnason, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): March 4, 2013
• Study Completion (Actual): March 4, 2013

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (Estimated): July 16, 2010

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Cardiac Rehabilitation; Rural; Weight reduction; Cardiac revascularization
• Other Study ID Numbers: 0177-09-FB; 1P20NR011404-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No