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

NCT01163968 | Completed DMC

• 2 other identifiers: 0177-09-FB1P20NR011404-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Diet behavior

  16 weeks after PCI

• Physical Activity behavior

  16 weeks after PCI

• Abdominal fat content percent (%) change

  16 weeks after PCI

• Diet behavior

  6 months after PCI

• Diet behavior

  9 months after PCI

Study Arms (1)

Weight reduction program

EXPERIMENTAL

MOMENTUM intervention

Behavioral: MOMENTUM

Interventions

MOMENTUM BEHAVIORAL

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.

Weight reduction program

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Mental status impairment as determined by a score of \> 8 on the Short-Portable Mental Status Questionnaire (SPMSQ)

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

BryanLGH Medical Center

Lincoln, Nebraska, 68506, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Magnesium Salicylate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Susan A Barnason, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 16, 2010
• Study Start: June 1, 2010
• Primary Completion: March 4, 2013
• Study Completion: March 4, 2013
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

US (1)