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Wellness Screening: Young Adults

 




Clinical Trial: Walking For Wellness

This study is no longer recruiting patients.

Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00156351

Purpose

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.

The specific behavioral objectives for this project are:

  1. Create positive expectations about increasing physical activity;
  2. Provide new expectations about increasing physical activity/provide short-term benefits of physical activity;
  3. Decrease pre-existing negative attitudes about exercise;
  4. Inoculate against anticipated negative consequences of physical activity;
  5. Increase the understanding about the health benefits of physical activity/increase understanding of the long-term consequences of a sedentary lifestyle;
  6. Increase cultural acceptability or sensibility for physical activity;
  7. Decrease the negative salience of physical activity within the culture;
  8. Increase the social rewards of being active and the use of physical activity as a social function;
  9. Decrease the opportunity costs of taking time for physical activity;
  10. Increase opportunities for physical activity on a daily basis;
  11. Increase self-efficacy, confidence, and knowledge with respect to physical activity;
  12. Increase body image knowledge and awareness as well as improve personal identity.

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 Intervention
Physical Inactivity
Obestity
 Behavior: Physical activity promotion

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment

Official Title: Evaluation of the National Black Women''''s Health Project

Further Study Details: 
Primary Outcomes: Physical activity level
Expected Total Enrollment:  186

Study start: January 2003;  Study completion: February 2006
Last follow-up: December 2005;  Data entry closure: February 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female
Criteria

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

Location Information


Pennsylvania
      3401 Market Street, Suite 202, Philadelphia,  Pennsylvania,  19104,  United States

Study chairs or principal investigators

Shiriki K Kumanyika, PhD, MPH, RD,  Principal Investigator,  University of Pennsylvania   

More Information

Study ID Numbers:  707525
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156351
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

Resources



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November 28, 2009



Page Updated: February 22, 2005
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