Walking For Wellness Program Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156351
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 28, 2008
Robert Wood Johnson Foundation
Information provided by:
University of Pennsylvania

Brief 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. 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:

  1. How well do the interventions address the program objectives ((quality of implementation), to be determined through protocol review for operationalization of theoretical constructs)?
  2. 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)?
  3. 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.
  4. 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)?
  5. 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)?
  6. Do changes in mediators explain changes in the primary outcomes (multivariate models to understand if presumed process of behavioral change was observed in practice)?
  7. 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)?

Condition or disease Intervention/treatment Phase
Physical Inactivity Obesity Behavioral: Physical activity promotion Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the National Black Women's Health Project Walking for Wellness Program
Study Start Date : January 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Physical activity level

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • African American Women
  • 18 years of age and older
  • Have a working telephone
  • Have reliable internet service

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00156351

United States, Pennsylvania
3401 Market Street, Suite 202
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Robert Wood Johnson Foundation
Principal Investigator: Shiriki K Kumanyika, PhD, MPH, RD University of Pennsylvania

Additional Information:
Responsible Party: Shiriki K. Kumanyika, PhD, MPH, RD, University of Pennsylvania Identifier: NCT00156351     History of Changes
Other Study ID Numbers: 707525
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Keywords provided by University of Pennsylvania:
African Americans
Telephone Counseling