WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women

This study is ongoing, but not recruiting participants.
Sponsor:
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: April 23, 2014
Last verified: April 2014
  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

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.

  • 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 around 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: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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

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.

  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 (self-reported non-exerciser for previous 6 months)
  • 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 greater than 179 mmHg systolic or 99 mmHg diastolic.
  • Participating in another research study which may effect the results of WalkMore
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519583

Locations
United States, Louisiana
Pennington Biomedical Research Center
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 by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
walking
physical activity
sedentary behavior

ClinicalTrials.gov processed this record on September 18, 2014