NCT00156351

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. 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. 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. 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. 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. 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. 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. 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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

2.9 years

First QC Date

September 8, 2005

Last Update Submit

March 26, 2008

Conditions

Keywords

African AmericansWomenInternetTelephone Counseling

Outcome Measures

Primary Outcomes (1)

  • Physical activity level

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3401 Market Street, Suite 202

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Sedentary BehaviorObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shiriki K Kumanyika, PhD, MPH, RD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations