WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women
Condition: Postmenopausal Disorder; Blood Pressure; Over Weight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Basic Intervention; Enhanced Pedometry; Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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; 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.
Other intervention name(s): Pedometry; No Pedometry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: walking; physical activity; sedentary behavior