WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women

Pennington Biomedical Research Center

Status: Completed

Conditions: Postmenopausal Disorder; Over Weight; Blood Pressure

Treatments: Behavioral: Control Group; Behavioral: Basic Intervention; Behavioral: Enhanced Pedometry

Study type: Interventional

Funder types: Other

Identifiers

NCT01519583

PBRC 11018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: Female

Ages: 45 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 3 patient groups, including a placebo group

Basic Pedometry Intervention

Experimental group

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)

Treatment:

Behavioral: Basic Intervention

Enhanced Pedometry Intervention

Experimental group

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);

Treatment:

Behavioral: Enhanced Pedometry

Control Group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Control Group