Women's Walking Program

Cardiovascular Diseases Clinical Trial

— WWP3  

Official title:

Reducing Health Disparities in African American Women: Lifestyle Physical Activity Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700894
• Other study ID #: 09021301-IRB01
• Secondary ID: R01NR004134
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: September 17, 2013
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

African American (AA) women have the lowest physical activity (PA) levels, which contributes to substantial disparities in cardiovascular health and depressive symptoms. There is a need to examine ways to promote PA that are appealing, applicable to clinical practice, and cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's Walking Program (WWP), consisting of a lifestyle PA prescription and "group visit" delivery model, with or without tailored telephone contacts between group visits for increasing adherence to PA and improving health outcomes. Two telephone contact strategies will be compared against a no-telephone control condition: a person-administered contact strategy using brief motivational interviewing and an automated contact strategy using a telephone computer-linked system. Group visits and telephone contacts are designed to increase adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in one's ability to be physically active) and outcome expectations (expected benefits to being more active); and (2) to compare cost-effectiveness of the three telephone treatment conditions in relation to adherence to lifestyle PA and health outcomes.

The investigators will randomly assignment of the order of administering the three conditions to six community health care sites. These six sites are similar with respect to race, socioeconomic status, and residential mobility. The study will include 288 sedentary AA women aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease (CVD); no history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP < 160/100.

Initial screening will occur in person or over the phone. Further screening at the data collection site with an advanced practice nurse will include blood work for glucose and lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all women who are eligible will: be given questionnaires on physical activity, health and factors that influence their physical activity; have their height, weight, waist circumference measured; and do a two minute step test. All three treatment group will attend 5 group visits every 5 weeks during adoption (first 24 weeks) and 1 booster group visit during maintenance (week 36). The group visit consists of brief individual time with a staff member followed by a group visit with motivational videotapes. All treatment groups will self-monitor their physical activity with accelerometers and enter their step data into a voice response system.

The groups receiving the automated telephone contact strategy and the group receiving the person telephone contact strategy will have the same number and spacing of the telephone contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks between group visits during adoption and two telephone contacts [weeks 28, 43] during maintenance). Using motivational interviewing, a nurse will tailor the telephone discussion to the person telephone contact group to match the participant's needs, experiences, barriers, motivation, and confidence. Women in the automated telephone contact group will receive an automated call with feedback on their progress based on the information they reported into the ATCL system. The automated telephone contact system will deliver feedback on progress, problem solving, goal-setting, and support. All information will be delivered in the voice of one of our staff members. The third treatment group will receive no telephone contacts between group visits.

Potential risks exist for women who have medical problems, which contraindicate physical exercise. Additional risks associated with the walking program include safety and injury. There are potential risks of infection at the site of the one time finger blood withdrawal. Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body composition and blood pressure and fewer symptoms. The subjects will be given a physical activity prescription that should benefit them through life and decrease their risk for CVD.

Women will be recruited throughout the West and South side of Chicago. They will give verbal consent at the screening questionnaire and sign an informed consent at the time of the screening history and physical. They will be told that participation is voluntary, they may decline or withdraw at will at any time, and all results will be held strictly confidential.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• AA female

• sedentary: Sedentary will be defined as no participation in regular planned (3 or more times a week) moderate (e.g., walking) or vigorous (e.g., jogging, speed walking) in the past 6 months.

• aged 40 to 65 years

• able to commit to attending the study group visits and have a telephone

• without disabilities that would prevent regular participation in PA such as walking as determined by the PARQ and baseline screening. PA

Exclusion Criteria:

• Women will be excluded from the study if they have major signs or symptoms of CV disease

• a history of myocardial infarction, stroke or Type 1 diabetes

• BP >160/100

• HgA1 >9 ( done on diabetics only)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Walking Program + Motivational Interviewing Calls

• Walking Program + Automated Calls

• Walking Program

Locations

Country	Name	City	State
United States	Austin Health Center of Cook County Health & Hospitals System	Chicago	Illinois
United States	Holy Cross Hospital	Chicago	Illinois
United States	Roseland Community Hospital	Chicago	Illinois
United States	University of Illinois at Chicago Mile Square Health Center	Chicago	Illinois
United States	University of Illinois at Chicago Mile Square Health Center at Back of the Yards	Chicago	Illinois
United States	Westside Health Authority	Chicago	Illinois
United States	Rush Oak Park Hospital	Oak Park	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to physical activity prescription	The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on increasing adherence to lifestyle physical activity over baseline physical activity.	baseline, 24, and 48 weeks	No
Secondary	Body Composition	The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on decreasing body composition over baseline body composition.; Body Composition measured with body mass index	24 and 48 weeks from baseline	No
Secondary	Depression	The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on improving depressive symptoms over baseline symptoms.; Depression is measured with the CES-D.	24 and 48 weeks from baseline	No
Secondary	Stress	The investigators will compare the effects at 24 weeks and 48 weeks of the WWP plus three telephone conditions on improving stress over baseline stress.; Stress is measured with Cohen's measure of Global Perceived Stress.	24 and 48 weeks from baseline	No