Cardiovascular DiseasesWWP3NCT01700894
Women's Walking Program
A study testing Walking Program + Motivational Interviewing Calls, Walking Program + Automated Calls and Walking Program in people with Cardiovascular Diseases, run by Rush University Medical Center at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Walking Program + Motivational Interviewing Calls, Walking Program + Automated Calls and Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2010to Oct 2012
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Illinois at Chicago Mile Square Health Center at Back of the Yards
Chicago, Illinois, 60609
University of Illinois at Chicago Mile Square Health Center
Chicago, Illinois, 60612
Roseland Community Hospital
Chicago, Illinois, 60628
Holy Cross Hospital
Chicago, Illinois, 60629
Austin Health Center of Cook County Health & Hospitals System
Chicago, Illinois, 60651
Westside Health Authority
Chicago, Illinois, 60651
Rush Oak Park Hospital
Oak Park, Illinois, 60304
About this study
Official title: Reducing Health Disparities in African American Women: Lifestyle Physical Activity Adherence
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.
Read more
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Walking Program + Motivational Interviewing Calls, Walking Program + Automated Calls, Walking Program
- Keywords
- Physical Activity, African American, Adherence
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Program + Motivational Interviewing CallsBehavioural
Walking Program + Automated CallsBehavioural
Walking ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Walking Program + motivational interviewing calls | Experimental | The Women's Walking Program (WWP) core included a lifestyle PA prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every week for 5 weeks in the 1st 24 weeks and 1 3 months later) targeted to increase lifestyle PA in AA women.
Participant in the WWP plus motivational interviewing telephone call arm receives 11 motivational interviewing telephone calls from an interventionist, with two calls in between each of the group-visits. Motivational interviewing calls are tailored to the individual and intended to sustain intervention effects between group-visits Receives: Behavioral: Walking Program + Motivational Interviewing Calls |
| Walking Program + automated calls | Experimental | The Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women.
Participants in the WWP plus automated telephone call arm receive 11 automated calls with two calls sent between each group-visit. The automated calls are intended to supplement and sustain the intervention effects of the group-visits. Receives: Behavioral: Walking Program + Automated Calls |
| Walking Program | Experimental | The Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women.
Participants in the WWP receive no telephone calls. Receives: Behavioral: Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 24, and 48 weeks
Secondary outcomes (3)
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
Measured: 24 and 48 weeks from baseline
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.
Measured: 24 and 48 weeks from baseline
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.
Measured: 24 and 48 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionOct 2012
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 Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, JoEllen Wilbur, PhD, APN, FAAN, Rush University Medical Center
- Investigators
- JoEllen Wilbur, PhD, Principal investigator, Rush University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700894
- Sponsor's protocol ID
- 09021301-IRB01
- Other IDs
- R01NR004134
- Acronym
- WWP3
- Status last verified
- Sep 2013
- First submitted
- 28 Sep 2012
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garland M, Wilbur J, Fogg L, Halloway S, Braun L, Miller A. Self-Efficacy, Outcome Expectations, Group Social Support, and Adherence to Physical Activity in African American Women. Nurs Res. 2021 Jul-Aug 01;70(4):239-247. doi: 10.1097/NNR.0000000000000516.
PubMed 33870956Wilbur J, Schoeny ME, Buchholz SW, Fogg L, Miller AM, Braun LT, Halloway S, Dancy BL. Women's Lifestyle Physical Activity Program for African American Women: Fidelity Plan and Outcomes. J Phys Act Health. 2016 Oct;13(10):1100-1109. doi: 10.1123/jpah.2015-0701. Epub 2016 Aug 16.
PubMed 27256816
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Disparities in African American Women: Lifestyle Physical Activity Adherence
- ClinicalTrials.gov ID
- NCT01700894
- Acronym / sponsor ID
- WWP3 / 09021301-IRB01
- Conditions
- Cardiovascular Diseases
- Keywords
- Physical Activity, African American, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Oct 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking Program + motivational interviewing calls | Experimental | Behavioral: Walking Program + Motivational Interviewing CallsThe Women's Walking Program (WWP) core included a lifestyle PA prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every week for 5 weeks in the 1st 24 weeks and 1 3 months later) targeted to increase lifestyle PA in AA women. Participant in the WWP plus motivational interviewing telephone call arm receives 11 motivational interviewing telephone calls from an interventionist, with two calls in between each of the group-visits. Motivational interviewing calls are tailored to the individual and intended to sustain intervention effects between group-visits |
| Walking Program + automated calls | Experimental | Behavioral: Walking Program + Automated CallsThe Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women. Participants in the WWP plus automated telephone call arm receive 11 automated calls with two calls sent between each group-visit. The automated calls are intended to supplement and sustain the intervention effects of the group-visits. |
| Walking Program | Experimental | Behavioral: Walking ProgramThe Women's Walking Program (WWP) core, including a lifestyle physical activity prescription with an accelerometer for self-feedback and monitoring and 6 group visits (1 every 5 weeks during the first 24 weeks and 1 3 months later) targeted to increase lifestyle physical activity in African American women. Participants in the WWP receive no telephone calls. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Walking Program + Motivational Interviewing Calls | Behavioural | Walking Program + motivational interviewing calls |
| Walking Program + Automated Calls | Behavioural | Walking Program + automated calls |
| Walking Program | Behavioural | Walking Program |
Primary outcome
Adherence to physical activity prescription
Time frame: baseline, 24, and 48 weeks
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.
3 secondary outcomes
Body Composition
Time frame: 24 and 48 weeks from baseline
Depression
Time frame: 24 and 48 weeks from baseline
Stress
Time frame: 24 and 48 weeks from baseline
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 18 Sep 2013.
- Derived from this study: PubMed 33870956Garland M, Wilbur J, Fogg L, Halloway S, Braun L, Miller A. Self-Efficacy, Outcome Expectations, Group Social Support, and Adherence to Physical Activity in African American Women. Nurs Res. 2021 Jul-Aug 01;70(4):239-247. doi: 10.1097/NNR.0000000000000516.
- Derived from this study: PubMed 27256816Wilbur J, Schoeny ME, Buchholz SW, Fogg L, Miller AM, Braun LT, Halloway S, Dancy BL. Women's Lifestyle Physical Activity Program for African American Women: Fidelity Plan and Outcomes. J Phys Act Health. 2016 Oct;13(10):1100-1109. doi: 10.1123/jpah.2015-0701. Epub 2016 Aug 16.
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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.
JoEllen Wilbur, PhD principal investigator
Rush University College of Nursing
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Program + Motivational Interviewing Calls, Walking Program + Automated Calls and Walking Program in people with Cardiovascular Diseases, run by Rush University Medical Center at 7 sites 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 5 inclusion and 4 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 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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?
Adherence to physical activity prescription (time frame: baseline, 24, and 48 weeks). 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 NCT01700894, 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 18 Sep 2013.