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

September 27, 2023 updated by: University of Nebraska
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight reduction
Time Frame: 16 weeks after PCI
Body Weight
16 weeks after PCI
Weight reduction
Time Frame: 6 months after PCI
Body Weight
6 months after PCI
Weight reduction
Time Frame: 9 months after PCI
Body Weight
9 months after PCI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diet behavior
Time Frame: 16 weeks after PCI
Heart Healthy Eating Self-Efficacy Scale
16 weeks after PCI
Physical Activity behavior
Time Frame: 16 weeks after PCI
Actigraph: mean levels of moderate activity
16 weeks after PCI
Abdominal fat content percent (%) change
Time Frame: 16 weeks after PCI
Waist Circumference
16 weeks after PCI
Diet behavior
Time Frame: 6 months after PCI
Heart Healthy Eating Self-Efficacy Scale
6 months after PCI
Diet behavior
Time Frame: 9 months after PCI
Heart Healthy Eating Self-Efficacy Scale
9 months after PCI
Physical Activity behavior
Time Frame: 6 months after PCI
Actigraph: mean levels of moderate activity
6 months after PCI
Physical Activity behavior
Time Frame: 9 months after PCI
Actigraph: mean levels of moderate activity
9 months after PCI
Abdominal fat content percent (%) change
Time Frame: 6 months after PCI
Waist Circumference
6 months after PCI
Abdominal fat content percent (%) change
Time Frame: 9 months after PCI
Waist circumference
9 months after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan A Barnason, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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