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WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women

Primary Purpose

Postmenopausal Disorder, Blood Pressure, Over Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Basic Intervention
Enhanced Pedometry
Control Group
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Disorder focused on measuring walking, physical activity, sedentary behavior

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Basic Pedometry Intervention

Enhanced Pedometry Intervention

Control Group

Arm Description

Basic pedometry intervention: Participants will have a goal of obtaining 10,000 steps/day (with no direction with regards to walking intensity/speed/cadence)

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);

Control group: Will maintain their usual activity and return for follow-up measures

Outcomes

Primary Outcome Measures

Resting systolic blood pressure
Measured in the seated position using AHA blood pressure measurement guidelines

Secondary Outcome Measures

Resting diastolic blood pressure
Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines
Accelerometry
An Accelerometry is a device that measures the amount of physical activity.
Brachial Ultrasound
Brachial Ultrasound is a measurement of the health of the artery, which measures the ability of the brachial artery to dilate.
Waist Circumference
Waist Circumference is the distance measured around the waist
Walking gait
Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.

Full Information

First Posted
January 18, 2012
Last Updated
September 13, 2022
Sponsor
Pennington Biomedical Research Center
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01519583
Brief Title
WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women
Official Title
Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Disorder, Blood Pressure, Over Weight
Keywords
walking, physical activity, sedentary behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic Pedometry Intervention
Arm Type
Experimental
Arm Description
Basic pedometry intervention: Participants will have a goal of obtaining 10,000 steps/day (with no direction with regards to walking intensity/speed/cadence)
Arm Title
Enhanced Pedometry Intervention
Arm Type
Experimental
Arm Description
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);
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control group: Will maintain their usual activity and return for follow-up measures
Intervention Type
Behavioral
Intervention Name(s)
Basic Intervention
Other Intervention Name(s)
Pedometry
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Pedometry
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Other Intervention Name(s)
No Pedometry
Intervention Description
Maintain usual physical activity, and return for follow-up measures.
Primary Outcome Measure Information:
Title
Resting systolic blood pressure
Description
Measured in the seated position using AHA blood pressure measurement guidelines
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Resting diastolic blood pressure
Description
Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines
Time Frame
3 Months
Title
Accelerometry
Description
An Accelerometry is a device that measures the amount of physical activity.
Time Frame
3 Months
Title
Brachial Ultrasound
Description
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
Title
Waist Circumference
Description
Waist Circumference is the distance measured around the waist
Time Frame
3 Months
Title
Walking gait
Description
Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.
Time Frame
3 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catrine Tudor-Locke, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31698336
Citation
Tudor-Locke C, Schuna JM, Swift DL, Dragg AT, Davis AB, Martin CK, Johnson WD, Church TS. Evaluation of Step-Counting Interventions Differing on Intensity Messages. J Phys Act Health. 2020 Jan 1;17(1):21-28. doi: 10.1123/jpah.2018-0439.
Results Reference
derived
PubMed Identifier
24528783
Citation
Tudor-Locke C, Swift DL, Schuna JM Jr, Dragg AT, Davis AB, Martin CK, Johnson WD, Church TS. WalkMore: a randomized controlled trial of pedometer-based interventions differing on intensity messages. BMC Public Health. 2014 Feb 15;14:168. doi: 10.1186/1471-2458-14-168.
Results Reference
derived

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WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women

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