Clinical trial NCT01519583: WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women
Official title: Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Disorder
Blood Pressure
Over Weight
Keywords: walking
physical activity
sedentary behavior
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2012-01-27
Enrollment: 115
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Resting systolic blood pressure
timeFrame: 3 Months
Secondary outcomes:
measure: Resting diastolic blood pressure
timeFrame: 3 Months
measure: Accelerometry
timeFrame: 3 Months
measure: Brachial Ultrasound
timeFrame: 3 Months
measure: Waist Circumference
timeFrame: 3 Months
measure: Walking gait
timeFrame: 3 Months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Catrine Tudor-Locke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.