WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women
|ClinicalTrials.gov Identifier: NCT01519583|
Recruitment Status : Unknown
Verified May 2015 by Catrine Tudor-Locke, Pennington Biomedical Research Center.
Recruitment status was: Active, not recruiting
First Posted : January 27, 2012
Last Update Posted : May 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Disorder Blood Pressure Over Weight||Behavioral: Basic Intervention Behavioral: Enhanced Pedometry Behavioral: Control Group||Not Applicable|
Baseline assessment, then a three month intervention or control condition, followed by another assessment at the end of the study. Participants will be screened for blood pressure, height, weight, and the distance around the waist. Participants who meet the eligibility criteria will be given a pedometer to log steps for one week. During visit 2, participants will return the pedometer, and are able to self-monitor appropriately, they will be given an accelerometer to wear for one week.
Participants will wear a small device which will measure the amount of steps accumulated for 7 days during the first week of the run-in period and again at follow-up (Control group will not perform follow-up pedometry).
Participants will be asked to wear a small device similar to a pedometer attached to a belt at the hip to measure physical activity levels for 7 days during the second week of the run-in period and again at the week prior to follow-up.
Assessment Visits (Baseline and 3 Months):
Blood pressure, brachial ultrasound (measure of the health of the artery), blood draw (fasting blood glucose and insulin), height, body weight, and waist measurement will be measured at the beginning of the main study and again after the 3-month period.
Brachial Artery Ultrasound:
An ultrasound is a procedure that uses sound waves to create a picture. The brachial artery ultrasound measures how elastic the arteries are and the thickness of the lining of the major blood vessel in the upper arm (the brachial artery). After resting for fifteen minutes, an ultrasound probe will be placed over the brachial artery in the elbow area on the non-dominant arm. A blood pressure cuff will be inflated around the forearm for five minutes to reduce blood flow. When the cuff is deflated, the ultrasound will be continued for five more minutes to observe the blood flowing back into the arm.
A fasting blood draw will occur to obtain fasting glucose and insulin.
Participants will walk across a 16 foot computerized floor mat, which will measure walking speed. After a couple practice walks, the participant will be asked to walk 2 times across the mat at 6 different self-selected paces: very slow, slow, preferred/normal, fast, very fast, and as quickly as possible (without running). The participant will be able to rest as needed. The computerized mat will measure walking speed and other elements associated with the pace at which the participant walks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
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.
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
- Resting systolic blood pressure [ Time Frame: 3 Months ]Measured in the seated position using AHA blood pressure measurement guidelines
- Resting diastolic blood pressure [ Time Frame: 3 Months ]Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines
- Accelerometry [ Time Frame: 3 Months ]An Accelerometry is a device that measures the amount of physical activity.
- Brachial Ultrasound [ Time Frame: 3 Months ]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 ]Waist Circumference is the distance measured around the waist
- Walking gait [ Time Frame: 3 Months ]Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519583
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Catrine Tudor-Locke, PhD||Pennington Biomedical Research Center|