- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203215
Examining Two Print-based Exercise Interventions for Women (WWP)
November 4, 2011 updated by: Temple University
Evaluating Self-Help Programs for Exercise Adoption and Maintenance in Women
Print-based interventions, specifically interventions that are theoretically-based have been shown to be effective for individuals.
These types of interventions are of particular importance for those individuals who, due to transportation, work, family, social, or financial demands have difficulty participating in face-to-face programs.
Therefore, we decided to test 2 such print based programs for women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We conducted a randomized controlled trial in which participants were randomly assigned to one of three groups: (1) Choose to Move (CTM), a gender-targeted intervention (2) Jumpstart, a motivationally-tailored print-based intervention, or (3) Wellness contact control group.
Objective and self-report measures of physical activity and psychosocial mediators of change were assessed at 3 months to evaluate the efficacy of the programs and maintenance of these programs will be conducted by examining a 9 month follow-up phase.
This design allows a direct comparison between two print-based physical activity self-help programs.
The use of non face-to-face interventions is critical to reach the large numbers of women in United States who are not physically active.
Tailored print materials (i.e., Jumpstart) will enable participants to have information that is matched to their level of motivation, and thus might be expected to be more efficacious than a standard self-help intervention.
Study Type
Interventional
Enrollment (Actual)
280
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- The Miriam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- healthy women
- sedentary
Exclusion Criteria:
- participating in > 90 minutes of purposeful physical activity (e.g., walking, cycling).
- medical problems that could potentially impede or exacerbated by physical activity
- history of coronary heart disease
- myocardial infraction
- symptoms of angina
- stroke
- diabetes
- osteoporosis
- osteoarthritis
- severe orthopedic problems.
- a planned move from the area within the next year
- current or planned pregnancy
- hospitalization for a psychiatric disorder within the last 3 years
- current suicidal or psychotic episodes
- currently using certain prescription medication such as beta blockers for hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JumpStart
|
physical activity promotion
|
Experimental: Choose to Move
|
physical activity promotion
|
Active Comparator: Wellness
|
physical activity promotion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical activity
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
physical activity
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Napolitano MA, Whiteley JA, Papandonatos G, Dutton G, Farrell NC, Albrecht A, Bock B, Bazzarre T, Sciamanna C, Dunn AL, Marcus BH. Outcomes from the women's wellness project: a community-focused physical activity trial for women. Prev Med. 2006 Dec;43(6):447-53. doi: 10.1016/j.ypmed.2006.06.011. Epub 2006 Aug 17.
- McAndrew LM, Napolitano MA, Albrecht A, Farrell NC, Marcus BH, Whiteley JA. When, why and for whom there is a relationship between physical activity and menopause symptoms. Maturitas. 2009 Oct 20;64(2):119-25. doi: 10.1016/j.maturitas.2009.08.009. Epub 2009 Sep 24.
- Dutton GR, Napolitano MA, Whiteley JA, Marcus BH. Is physical activity a gateway behavior for diet? Findings from a physical activity trial. Prev Med. 2008 Mar;46(3):216-21. doi: 10.1016/j.ypmed.2007.12.012. Epub 2008 Jan 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 14, 2010
First Submitted That Met QC Criteria
September 14, 2010
First Posted (Estimate)
September 16, 2010
Study Record Updates
Last Update Posted (Estimate)
November 6, 2011
Last Update Submitted That Met QC Criteria
November 4, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RWJF044224
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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