InactivityPhase 2NCT00724165
Seamos Activas: Increasing Physical Activity Among Latinas
A Phase 2 study testing Intervention in people with Inactivity, run by University of California, San Diego at 1 site in United States.
Trial summary
The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). 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
- Inactivity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2009
- 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
- Sedentary (i.e., participating in moderate or vigorous physical activity two days per week or less for 30 minutes or less each day) women ages 18 to 65 who self-identify as Latina (or of a group defined as Hispanic/Latino by the Census Bureau) are eligible for participation
Who cannot join
- Exclusion criteria are history of coronary heart disease (history of myocardial infarction or symptoms of angina), diabetes, stroke, osteoarthritis, osteoporosis, orthopedic problems, or any other serious medical condition that would make physical activity unsafe. Other exclusion criteria will include individuals who report consuming three or more alcoholic drinks per day, current or planned pregnancy, planning to move from the area within the next six months, current suicidal ideation or psychosis, current clinical depression, hospitalization due to a psychiatric disorder in the past 3 years, BMI above 40, and/or taking medication that may impair physical activity tolerance or performance (e.g., beta blockers). Participants in the pilot study must also agree to be assigned to one of the two intervention conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.
Read the detailed description
While the general United States population is suffering from an epidemic of sedentary lifestyle, Latinos are even more sedentary than their non-Hispanic white counterparts. Notably, Latinos suffer from greater rates of morbidity and mortality of conditions associated with being sedentary than non-Hispanic whites. One concern is that due to cultural artifacts, socioeconomic circumstances, and language barriers, Latinos have limited access to public health interventions that promote active lifestyles. The current study will advance nursing science by using a theory-based computer-run expert system to provide an effective physical activity intervention for this underserved population. The consent form was completed by all participants and describes the nature and purpose of the study, procedure, risks and benefits to participating, alternative therapies available, and confidentiality.
- Conditions
- Inactivity
- Being tested
- Intervention, Control
- Keywords
- physical activity, Latinas
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Culturally-modified, individually tailored physical activity print materials
ControlBehavioural
Bilingual health education booklets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Intervention |
| 2 | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported physical activity
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startSep 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InactivityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Dr.Bess Marcus, University of California, San Diego
- Investigators
- Bess H Marcus, PhD, Principal investigator, Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724165
- Sponsor's protocol ID
- R21NR009864
- Other IDs
- R21NR009864
- Status last verified
- Feb 2013
- First submitted
- 25 Jul 2008
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pekmezi DW, Neighbors CJ, Lee CS, Gans KM, Bock BC, Morrow KM, Marquez B, Dunsiger S, Marcus BH. A culturally adapted physical activity intervention for Latinas: a randomized controlled trial. Am J Prev Med. 2009 Dec;37(6):495-500. doi: 10.1016/j.amepre.2009.08.023.
PubMed 19944914
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seamos Activas: Increasing Physical Activity Among Latinas
- ClinicalTrials.gov ID
- NCT00724165
- Acronym / sponsor ID
- R21NR009864
- Conditions
- Inactivity
- Keywords
- physical activity, Latinas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Jul 2008 (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.
The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women). The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.
Detailed description
While the general United States population is suffering from an epidemic of sedentary lifestyle, Latinos are even more sedentary than their non-Hispanic white counterparts. Notably, Latinos suffer from greater rates of morbidity and mortality of conditions associated with being sedentary than non-Hispanic whites. One concern is that due to cultural artifacts, socioeconomic circumstances, and language barriers, Latinos have limited access to public health interventions that promote active lifestyles. The current study will advance nursing science by using a theory-based computer-run expert system to provide an effective physical activity intervention for this underserved population. The consent form was completed by all participants and describes the nature and purpose of the study, procedure, risks and benefits to participating, alternative therapies available, and confidentiality.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Intervention |
| 2 | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sedentary (i.e., participating in moderate or vigorous physical activity two days per week or less for 30 minutes or less each day) women ages 18 to 65 who self-identify as Latina (or of a group defined as Hispanic/Latino by the Census Bureau) are eligible for participation
Key exclusion criteria (1 listed)
- Exclusion criteria are history of coronary heart disease (history of myocardial infarction or symptoms of angina), diabetes, stroke, osteoarthritis, osteoporosis, orthopedic problems, or any other serious medical condition that would make physical activity unsafe. Other exclusion criteria will include individuals who report consuming three or more alcoholic drinks per day, current or planned pregnancy, planning to move from the area within the next six months, current suicidal ideation or psychosis, current clinical depression, hospitalization due to a psychiatric disorder in the past 3 years, BMI above 40, and/or taking medication that may impair physical activity tolerance or performance (e.g., beta blockers). Participants in the pilot study must also agree to be assigned to one of the two intervention conditions.
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 |
|---|---|---|
| InterventionCulturally-modified, individually tailored physical activity print materials | Behavioural | 1 |
| ControlBilingual health education booklets | Behavioural | 2 |
Primary outcome
Self-Reported physical activity
Time frame: Baseline, 3 months, and 6 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 6 Feb 2013.
- Derived from this study: PubMed 19944914Pekmezi DW, Neighbors CJ, Lee CS, Gans KM, Bock BC, Morrow KM, Marquez B, Dunsiger S, Marcus BH. A culturally adapted physical activity intervention for Latinas: a randomized controlled trial. Am J Prev Med. 2009 Dec;37(6):495-500. doi: 10.1016/j.amepre.2009.08.023.
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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.
Bess H Marcus, PhD principal investigator
Alpert Medical School of Brown University
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 Intervention in people with Inactivity, run by University of California, San Diego 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 1 inclusion and 1 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 6 Feb 2013. 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?
Self-Reported physical activity (time frame: Baseline, 3 months, and 6 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 NCT00724165, which also lists 1 linked publication.
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 6 Feb 2013.