Physical Activity BehaviorPhase 2WWPNCT01203215
Examining Two Print-based Exercise Interventions for Women
A Phase 2 study testing 2 print based physical activity interventions in people with Physical Activity Behavior, run by Temple University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity Behavior
- What is being tested?
- 2 print based physical activity interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2005
- Phase
- Phase 2
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy women
- sedentary
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity Behavior
- Being tested
- 2 print based physical activity interventions
- Keywords
- exercise, physical activity, women, community
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 print based physical activity interventionsBehavioural
physical activity promotion
| Study group | Role | What they receive |
|---|---|---|
| JumpStart | Experimental | Not described Receives: Behavioral: 2 print based physical activity interventions |
| Choose to Move | Experimental | Not described Receives: Behavioral: 2 print based physical activity interventions |
| Wellness | Active comparator | Not described Receives: Behavioral: 2 print based physical activity interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Measured: 3 months
Secondary outcomes (1)
physical activity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJun 2002
- Primary completionJun 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical Activity BehaviorStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203215
- Sponsor's protocol ID
- RWJF044224
- Acronym
- WWP
- Status last verified
- Sep 2010
- First submitted
- 14 Sep 2010
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16919322McAndrew 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.
PubMed 19781877Dutton 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.
PubMed 18234327
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Self-Help Programs for Exercise Adoption and Maintenance in Women
- ClinicalTrials.gov ID
- NCT01203215
- Acronym / sponsor ID
- WWP / RWJF044224
- Conditions
- Physical Activity Behavior
- Keywords
- exercise, physical activity, women, community
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- The Miriam Hospital
- Study start
- Jun 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 16 Sep 2010 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JumpStart | Experimental | Behavioral: 2 print based physical activity interventions |
| Choose to Move | Experimental | Behavioral: 2 print based physical activity interventions |
| Wellness | Active comparator | Behavioral: 2 print based physical activity interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy women
- sedentary
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| 2 print based physical activity interventionsphysical activity promotion | Behavioural | Choose to Move, JumpStart, Wellness |
Primary outcome
Physical activity
Time frame: 3 months
1 secondary outcome
physical activity
Time frame: 12 months
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 7 Nov 2011.
- Results publication: PubMed 16919322Napolitano 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.
- Results publication: PubMed 19781877McAndrew 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.
- Results publication: PubMed 18234327Dutton 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2 print based physical activity interventions in people with Physical Activity Behavior, run by Temple University 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 2 inclusion and 15 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 7 Nov 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203215, which also lists 3 linked publications.
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 7 Nov 2011; AzTrials last refreshed its copy on 29 Oct 2026.