An interventional study of Basic Intervention and Enhanced Pedometry in Postmenopausal Disorder, Blood Pressure and Over Weight, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to female participants aged 45 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Treatment
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.
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.
Pedometry:
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).
Accelerometry:
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.
Blood Draw:
A fasting blood draw will occur to obtain fasting glucose and insulin.
Walking Gait:
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 115 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Control group: Will maintain their usual activity and return for follow-up measures
Behavioral: Control Group
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
Also known as: 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.
Maintain usual physical activity, and return for follow-up measures.
Also known as: No Pedometry
Resting systolic blood pressure
Measured in the seated position using AHA blood pressure measurement guidelines
Time frame: 3 Months
Resting diastolic blood pressure
Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines
Time frame: 3 Months
Accelerometry
An Accelerometry is a device that measures the amount of physical activity.
Time frame: 3 Months
Brachial Ultrasound
Brachial Ultrasound is a measurement of the health of the artery, which measures the ability of the brachial artery to dilate.
Time frame: 3 Months
Waist Circumference
Waist Circumference is the distance measured around the waist
Time frame: 3 Months
Walking gait
Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.
Time frame: 3 Months
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Pennington Biomedical Research Center