Physical InactivityNCT00156351
Walking For Wellness Program Evaluation
A study testing Physical activity promotion in people with Physical Inactivity and Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall purpose of this project is to conduct an innovative, culturally-tailored demonstration project designed to facilitate the adoption and maintenance of regular, moderate physical activity (i.e., brisk walking) in a sample of sedentary African American women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Inactivity, Obesity
- What is being tested?
- Physical activity promotion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Dec 2005
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American Women
- 18 years of age and older
- Have a working telephone
- Have reliable internet service
Who cannot join
- Men
- Physical limitations and/or disabilities that would preclude a walking program
- Report currently meeting the minimum physical activity guidelines, as they relate to health and/or weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
3401 Market Street, Suite 202
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of the National Black Women's Health Project Walking for Wellness Program
The overall purpose of this project is to conduct an innovative, culturally-tailored demonstration project designed to facilitate the adoption and maintenance of regular, moderate physical activity (i.e., brisk walking) in a sample of sedentary African American women. In addition, we will test the impact of varying types of counseling and social support on the adoption and maintenance of regular physical activity and help women improve their weight control. The core behavioral change program will be based on a comprehensive wellness oriented website offered by the National Black Women's Health Project (NBWHP). Comparisons will be made between the effects of the web-based program with only minimal face to face contacts, primarily for enrollment, data collection, and participant retention, the web-based program with the addition of telephone counseling and support, and the web-based program with face to face group counseling and support.
Hypotheses. Hypothesis 1. Participation in the intervention will result in increased physical activity levels, regardless of the level of social support.
Read more
Hypothesis 2. The intervention arm involving the lowest level of social support will be marginally effective for increasing physical activity levels, and additional social support will result in significantly improved physical activity levels when compared with the lowest level of social support.
The specific intervention questions are:
- How well do the interventions address the program objectives ((quality of implementation), to be determined through protocol review for operationalization of theoretical constructs)?
- Was the program implemented as planned ((fidelity to protocol and dose of intervention), to be determined from implementation process variables, including characteristics of women recruited, fidelity to protocols for contact with participants, and quality of counseling given, where applicable)?
- Did the program (separately for each format tested) have a significant effect on potential mediators of behavior change (influence on presumed intermediate outcomes)? For the purpose of this proposal, a mediator is defined as any barrier to or facilitator of physical activity participation (e.g., time, self efficacy, social support, access, perceived norms) as implied in the 12 behavioral objectives that have been specified.
- What is the optimum type of counseling and support to enhance the on-line activities in order to produce significant behavior change (importance of various program components)?
- Did the program (separately for each format tested) have a significant effect on the primary study outcomes (influence on primary behavioral outcome, e.g., physical activity by self-report of activity levels or pedometer counts)?
- Do changes in mediators explain changes in the primary outcomes (multivariate models to understand if presumed process of behavioral change was observed in practice)?
- Does the internet only program appear to result in increased physical activity participation when compared to extant data on trends among Black women in the U.S. population (what is accomplished with very minimal intervention and how does it compare with a more extensive program)?
- Conditions
- Physical Inactivity, Obesity
- Being tested
- Physical activity promotion
- Keywords
- African Americans, Women, Internet, Telephone Counseling
- Medical subject headings
- Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity promotionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Shiriki K Kumanyika, PhD, MPH, RD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156351
- Sponsor's protocol ID
- 707525
- Status last verified
- Mar 2008
- First submitted
- 8 Sep 2005
- Last updated
- 28 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the National Black Women's Health Project Walking for Wellness Program
- ClinicalTrials.gov ID
- NCT00156351
- Acronym / sponsor ID
- 707525
- Conditions
- Physical Inactivity, Obesity
- Keywords
- African Americans, Women, Internet, Telephone Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jan 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Sep 2005 (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.
The overall purpose of this project is to conduct an innovative, culturally-tailored demonstration project designed to facilitate the adoption and maintenance of regular, moderate physical activity (i.e., brisk walking) in a sample of sedentary African American women. In addition, we will test the impact of varying types of counseling and social support on the adoption and maintenance of regular physical activity and help women improve their weight control. The core behavioral change program will be based on a comprehensive wellness oriented website offered by the National Black Women's Health Project (NBWHP). Comparisons will be made between the effects of the web-based program with only minimal face to face contacts, primarily for enrollment, data collection, and participant retention, the web-based program with the addition of telephone counseling and support, and the web-based program with face to face group counseling and support.
Hypotheses. Hypothesis 1. Participation in the intervention will result in increased physical activity levels, regardless of the level of social support.
Hypothesis 2. The intervention arm involving the lowest level of social support will be marginally effective for increasing physical activity levels, and additional social support will result in significantly improved physical activity levels when compared with the lowest level of social support.
The specific intervention questions are:
- How well do the interventions address the program objectives ((quality of implementation), to be determined through protocol review for operationalization of theoretical constructs)?
- Was the program implemented as planned ((fidelity to protocol and dose of intervention), to be determined from implementation process variables, including characteristics of women recruited, fidelity to protocols for contact with participants, and quality of counseling given, where applicable)?
- Did the program (separately for each format tested) have a significant effect on potential mediators of behavior change (influence on presumed intermediate outcomes)? For the purpose of this proposal, a mediator is defined as any barrier to or facilitator of physical activity participation (e.g., time, self efficacy, social support, access, perceived norms) as implied in the 12 behavioral objectives that have been specified.
- What is the optimum type of counseling and support to enhance the on-line activities in order to produce significant behavior change (importance of various program components)?
- Did the program (separately for each format tested) have a significant effect on the primary study outcomes (influence on primary behavioral outcome, e.g., physical activity by self-report of activity levels or pedometer counts)?
- Do changes in mediators explain changes in the primary outcomes (multivariate models to understand if presumed process of behavioral change was observed in practice)?
- Does the internet only program appear to result in increased physical activity participation when compared to extant data on trends among Black women in the U.S. population (what is accomplished with very minimal intervention and how does it compare with a more extensive program)?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American Women
- 18 years of age and older
- Have a working telephone
- Have reliable internet service
Key exclusion criteria (3 listed)
- Men
- Physical limitations and/or disabilities that would preclude a walking program
- Report currently meeting the minimum physical activity guidelines, as they relate to health and/or weight loss
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 |
|---|---|---|
| Physical activity promotion | Behavioural | – |
Primary outcome
Physical activity level
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 28 Mar 2008.
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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.
Shiriki K Kumanyika, PhD, MPH, RD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity promotion in people with Physical Inactivity and Obesity, run by University of Pennsylvania at 1 site 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 4 inclusion and 3 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 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Physical activity level. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2008; AzTrials last refreshed its copy on 27 Oct 2026.