WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women
This study is currently recruiting participants.
Verified December 2012 by Pennington Biomedical Research Center
Sponsor:
Pennington Biomedical Research Center
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Catrine Tudor-Locke, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01519583
First received: January 18, 2012
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
The WalkMore study will help find out how walking interventions can help overweight/obese postmenopausal women with increased risk of cardiovascular disease lower their blood pressure.
| Condition | Intervention |
|---|---|
|
Postmenopausal Disorder Blood Pressure Over Weight |
Behavioral: Basic Intervention Behavioral: Enhanced Pedometry Behavioral: Control Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore |
Resource links provided by NLM:
Further study details as provided by Pennington Biomedical Research Center:
Primary Outcome Measures:
- Resting systolic blood pressure [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Measured in the seated position using AHA blood pressure measurement guidelines
Secondary Outcome Measures:
- Resting diastolic blood pressure [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines
- Accelerometry [ Time Frame: 3 Months ] [ Designated as safety issue: No ]An Accelerometry is a device that measures the amount of physical activity.
- Fitness Level [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Fitness level is evaluated with the use of a treadmill test
- Brachial Ultrasound [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Brachial Ultrasound is a measurement of the health of the artery, which measures the ability of the brachial artery to dilate.
- Waist Circumference [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Waist Circumference is the distance measured arund the waist
- Walking gait [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Basic Pedometry Intervention
Basic pedometry intervention: Participants will have a goal of obtaining 10,000 steps/day (with no direction with regards to walking intensity/speed/cadence)
|
Behavioral: Basic Intervention
Participants will have the goal of obtaining 10,000 steps/day. In addition, participants will attend a meeting once a week with study staff, during which pedometers will be checked, and staff will provide a behavioral intervention to improve physical activity levels
Other Name: Pedometry
|
|
Experimental: Enhanced Pedometry Intervention
Enhanced pedometry Intervention: Participants will have the goal of obtaining 10,000 steps/day and at least 30 minutes in moderate intensity (i.e., at a cadence of at least 100 steps/min);
|
Behavioral: Enhanced Pedometry
Intensity Enhanced Pedometry: Participants will have the goal of obtaining 10,000 steps/day at least 30 minutes in moderate intensity (i.e., at a cadence of at least 100 steps/min). In addition, participants will attend a meeting once a week with study staff, during which pedometers will be checked, and the staff will provide a behavioral intervention to improve physical activity levels.
Other Name: Enhanced Pedometry
|
|
Placebo Comparator: Control Group
Control group: Will maintain their usual activity and return for follow-up measures
|
Behavioral: Control Group
Maintain usual physical activity, and return for follow-up measures.
Other Name: No Pedometry
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years to 74 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Woman between 45-74 years of age
- Have not had a menstrual period for at least 12 months
- Are not regularly physically active
- Have a body mass index (BMI) between 25-45 kg/m2
- Have high normal blood pressure or (systolic pressure of 130-179 mmHg or a diastolic pressure of 85-99 mmHg)
- Not limited in your ability to walk
- Understand these criteria
- Are willing to provide informed consent
- Willing to be randomized to either type of walking intervention or a control group being studied, and are willing to follow the protocol for the group to which they have been assigned
Exclusion Criteria:
- Have a past history and/or physical examination or laboratory findings of a medical condition including (but not limited to):
- Have any medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise
- Have been diagnosed with diabetes
- Blood pressure is less than 130 mmHg systolic or 85 mmHg diastolic.
- Blood pressure is greater than 179 mmHg systolic or 99 mmHg diastolic.
- Participating in another research study which may effect the results of WalkMore
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519583
Contacts
| Contact: Catrine E Tudor-Locke, Ph.D. | 225-763-2974 | Catrine.Tudor-Locke@pbrc.edu |
| Contact: Damon L Swift, Ph.D. | 225-763-2917 | Damon.Swift@pbrc.edu |
Locations
| United States, Louisiana | |
| Pennington Biomedical Research Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
Sponsors and Collaborators
Pennington Biomedical Research Center
American Heart Association
Investigators
| Principal Investigator: | Catrine Tudor-Locke, PhD | Pennington Biomedical Research Center |
More Information
No publications provided
| Responsible Party: | Catrine Tudor-Locke, Principal Invesigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT01519583 History of Changes |
| Other Study ID Numbers: | PBRC11018 |
| Study First Received: | January 18, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013