Postmenopausal DisorderNCT01519583
WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women
A study testing Basic Intervention and Enhanced Pedometry in people with Postmenopausal Disorder and Blood Pressure, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women only
- Conditions the study is for
- Postmenopausal Disorder, Blood Pressure, Over Weight
- What is being tested?
- Basic Intervention and Enhanced Pedometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
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.
Read the 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.
- Conditions
- Postmenopausal Disorder, Blood Pressure, Over Weight
- Being tested
- Basic Intervention, Enhanced Pedometry, Control Group
- Keywords
- walking, physical activity, sedentary behavior
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic InterventionBehavioural
Also called Pedometry
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
Enhanced PedometryBehavioural
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.
Control GroupBehavioural
Also called No Pedometry
Maintain usual physical activity, and return for follow-up measures.
| Study group | Role | What they receive |
|---|---|---|
| Basic Pedometry Intervention | Experimental | Basic pedometry intervention: Participants will have a goal of obtaining 10,000 steps/day (with no direction with regards to walking intensity/speed/cadence) Receives: Behavioral: Basic Intervention |
| Enhanced Pedometry Intervention | Experimental | 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); Receives: Behavioral: Enhanced Pedometry |
| Control Group | Placebo comparator | Control group: Will maintain their usual activity and return for follow-up measures Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting systolic blood pressure
Measured in the seated position using AHA blood pressure measurement guidelines
Measured: 3 Months
Secondary outcomes (5)
Resting diastolic blood pressure
Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines
Measured: 3 Months
Accelerometry
An Accelerometry is a device that measures the amount of physical activity.
Measured: 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.
Measured: 3 Months
Waist Circumference
Waist Circumference is the distance measured around the waist
Measured: 3 Months
Walking gait
Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Catrine Tudor-Locke, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519583
- Sponsor's protocol ID
- PBRC 11018
- Status last verified
- Sep 2022
- First submitted
- 18 Jan 2012
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31698336Tudor-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.
PubMed 24528783
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
- ClinicalTrials.gov ID
- NCT01519583
- Acronym / sponsor ID
- PBRC 11018
- Conditions
- Postmenopausal Disorder, Blood Pressure, Over Weight
- Keywords
- walking, physical activity, sedentary behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- May 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic Pedometry Intervention | Experimental | Behavioral: Basic InterventionBasic 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 | Experimental | Behavioral: Enhanced PedometryEnhanced 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 | Placebo comparator | Behavioral: Control GroupControl group: Will maintain their usual activity and return for follow-up measures |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic InterventionAlso: PedometryParticipants 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 | Behavioural | Basic Pedometry Intervention |
| Enhanced PedometryIntensity 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. | Behavioural | Enhanced Pedometry Intervention |
| Control GroupAlso: No PedometryMaintain usual physical activity, and return for follow-up measures. | Behavioural | Control Group |
Primary outcome
Resting systolic blood pressure
Time frame: 3 Months
Measured in the seated position using AHA blood pressure measurement guidelines
5 secondary outcomes
Resting diastolic blood pressure
Time frame: 3 Months
Accelerometry
Time frame: 3 Months
Brachial Ultrasound
Time frame: 3 Months
Waist Circumference
Time frame: 3 Months
Walking gait
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 31698336Tudor-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.
- Derived from this study: PubMed 24528783Tudor-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catrine Tudor-Locke, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Intervention and Enhanced Pedometry in people with Postmenopausal Disorder and Blood Pressure, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting systolic blood pressure (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.