WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women

NCT01519583 | Completed

• 1 other identifier: PBRC 11018
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Disorder; Blood Pressure; Over Weight

Keywords

walking; physical activity; sedentary behavior

Outcome Measures

Primary Outcomes (1)

• Resting systolic blood pressure

  Measured in the seated position using AHA blood pressure measurement guidelines

  3 Months

Secondary Outcomes (5)

• Resting diastolic blood pressure

  3 Months

• Accelerometry

  3 Months

• Brachial Ultrasound

  3 Months

• Waist Circumference

  3 Months

• Walking gait

  3 Months

Study Arms (3)

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)

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);

Behavioral: Enhanced Pedometry

Control Group

PLACEBO COMPARATOR

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

Behavioral: Control Group

Interventions

Basic Intervention BEHAVIORAL

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

Also known as: Pedometry

Basic Pedometry Intervention

Enhanced Pedometry BEHAVIORAL

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.

Enhanced Pedometry Intervention

Control Group BEHAVIORAL

Maintain usual physical activity, and return for follow-up measures.

Also known as: No Pedometry

Control Group

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• American Heart Association: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• 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.

  PMID: 31698336 DERIVED

• 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.

  PMID: 24528783 DERIVED

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Catrine Tudor-Locke, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 27, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

US (1)