ObesityMOMENTUMNCT01163968
Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
A study testing MOMENTUM in people with Obesity, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MOMENTUM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2010to 4 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mental status impairment as determined by a score of > 8 on the Short-Portable Mental Status Questionnaire (SPMSQ)
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Obesity
- Being tested
- MOMENTUM
- Keywords
- Weight reduction, Cardiac revascularization, Percutaneous Coronary Intervention, Cardiac Rehabilitation, Rural
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMENTUMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight reduction program | Experimental | MOMENTUM intervention Receives: Behavioral: MOMENTUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
Body Weight
Measured: 16 weeks after PCI
Weight reduction
Body Weight
Measured: 6 months after PCI
Weight reduction
Body Weight
Measured: 9 months after PCI
Secondary outcomes (9)
Diet behavior
Heart Healthy Eating Self-Efficacy Scale
Measured: 16 weeks after PCI
Physical Activity behavior
Actigraph: mean levels of moderate activity
Measured: 16 weeks after PCI
Abdominal fat content percent (%) change
Waist Circumference
Measured: 16 weeks after PCI
Diet behavior
Heart Healthy Eating Self-Efficacy Scale
Measured: 6 months after PCI
Diet behavior
Heart Healthy Eating Self-Efficacy Scale
Measured: 9 months after PCI
Physical Activity behavior
Actigraph: mean levels of moderate activity
Measured: 6 months after PCI
Physical Activity behavior
Actigraph: mean levels of moderate activity
Measured: 9 months after PCI
Abdominal fat content percent (%) change
Waist Circumference
Measured: 6 months after PCI
Abdominal fat content percent (%) change
Waist circumference
Measured: 9 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study start1 Jun 2010
- Primary completion4 Mar 2013
- Study completion4 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Susan A Barnason, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163968
- Sponsor's protocol ID
- 0177-09-FB
- Other IDs
- 1P20NR011404-01
- Acronym
- MOMENTUM
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2010
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)
- ClinicalTrials.gov ID
- NCT01163968
- Acronym / sponsor ID
- MOMENTUM / 0177-09-FB
- Conditions
- Obesity
- Keywords
- Weight reduction, Cardiac revascularization, Percutaneous Coronary Intervention, Cardiac Rehabilitation, Rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 4 Mar 2013 (actual)
- Study completion
- 4 Mar 2013 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight reduction program | Experimental | Behavioral: MOMENTUMMOMENTUM intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The sample for the proposed study will be 50 overweight or obese adults who have had a PCI who meet the following criteria:
Key exclusion criteria (1 listed)
- Mental status impairment as determined by a score of > 8 on the Short-Portable Mental Status Questionnaire (SPMSQ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOMENTUMThe 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. | Behavioural | Weight reduction program |
Primary outcome
Weight reduction
Time frame: 16 weeks after PCI
Body Weight
Weight reduction
Time frame: 6 months after PCI
Body Weight
Weight reduction
Time frame: 9 months after PCI
Body Weight
9 secondary outcomes
Diet behavior
Time frame: 16 weeks after PCI
Physical Activity behavior
Time frame: 16 weeks after PCI
Abdominal fat content percent (%) change
Time frame: 16 weeks after PCI
Diet behavior
Time frame: 6 months after PCI
Diet behavior
Time frame: 9 months after PCI
Physical Activity behavior
Time frame: 6 months after PCI
Physical Activity behavior
Time frame: 9 months after PCI
Abdominal fat content percent (%) change
Time frame: 6 months after PCI
Abdominal fat content percent (%) change
Time frame: 9 months after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan A Barnason, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMENTUM in people with Obesity, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight reduction (time frame: 16 weeks after PCI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.