InactivityNCT01834287
Pasos Hacia La Salud - Physical Activity Intervention for Latinas
A study testing Physical Activity Intervention in people with Inactivity, run by University of California, San Diego at 1 site in United States.
Trial summary
In this study, investigators are specifically targeting Latina women as they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions such as obesity, diabetes, or cardiovascular disease. 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?
- Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female
- Generally healthy (If asthma and/or high blood pressure, may be able to participate with physician consent)
- Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
- Latina (self-identified)
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
- Planning on living in the area for the next 12 months
- Daily access to a computer with high speed internet
Who cannot join
- Pregnant or planning on becoming pregnant
- BMI greater than 45
- Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
- Exercise is against advice of doctor
- Heart disease/treatment
- Heart murmur
Show all 28Show fewer
- Angina/chest pain or Angina/chest pain with exertion
- Palpitations
- Stroke/Transient Ischemic Attacks
- Peripheral Vascular Disease
- Diabetes I or II
- Chronic Infectious Disease - HIV, Hepatitis
- Chronic liver disease
- Cystic Fibrosis
- Abnormal EKG on last EKG performed
- Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
- Seizure in past year
- Surgery in past year on heart, lung, joint, orthopedic surgery
- Surgery pending in next year on lung, joint, orthopedic surgery
- Unusual/concerning shortness of breath
- Asthma (may be able to participate with physician consent)
- High blood pressure/high blood pressure medication (may be able to participate with physician consent)
- Use of beta blockers
- Abnormal Medical Stress Test
- Musculoskeletal problems
- Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
- Cancer treatment in past 3 months
- Hospitalized for psychiatric disorder in past 3 years or suicidal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: Promoting Physical Activity in Latinas Via Interactive Web-Based Technology
In this study, investigators are specifically targeting Latina women as they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions such as obesity, diabetes, or cardiovascular disease.
The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact Control condition. Participants are randomly assigned to one of two groups (Exercise and General Wellness).
The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants.
Read the detailed description
In the U.S., Latino women (Latinas) report higher rates of inactivity than their non-Hispanic White and male counterparts and thus are disproportionately burdened by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). Cultural factors, socioeconomic circumstances, language and educational barriers limit Latinas access to public health interventions that promote physically active lifestyles. To address this public health crisis, effective interventions that leverage state-of-the-art theory and methods are needed to reach this at-risk population. Our research group has over 20 years experience developing and evaluating individually-tailored, computer expert system-driven, physical activity interventions (based on Social Cognitive Theory and the Transtheoretical Model) through various channels and settings. In our recent pilot (R21NR009864), we culturally and linguistically adapted our tailored intervention for sedentary Latinas and conducted a small randomized trial of the modified program (N=93). A total of 81 participants completed the 6-month study (87% retention) and increased their physical activity from a mean of 17 minutes per week (SD=25.76) at baseline to 147 minutes (SD=241.55) at six months whereas contact control participants increased their physical activity from 12 minutes per week (SD=21.99) at baseline to 97 minutes (SD=118.49) at six months. These observed improvements in physical activity in our intervention group, along with high retention rates, participant-reported desire for an Internet-delivered program, and formative work developing our program in an Internet format lend support for testing an Internet intervention tailored to the needs of Latinas. Therefore, for the current proposal, we will build on our previous work by conducting an adequately powered (N=200) randomized controlled trial to test the efficacy of our culturally and linguistically modified, individually tailored physical activity intervention delivered via the Internet relative to an Internet wellness contact control condition (including cardiovascular health information developed for Latinos by the NHLBI). Data will be collected at baseline, 6 months (post-treatment), and 12 months (maintenance) using well-established physical activity measures (7-Day PAR, Actigraphs), as well as a comprehensive set of psychosocial questionnaires. We hypothesize that at end of treatment (month six) intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants. We will also examine the maintenance of treatment effects at 12 months, potential mediators and moderators of the intervention-physical activity relationship, and the costs of delivering the tailored Internet program. In the proposed study we seek to promote physical activity among an underserved population using a high-reach, low-cost, technology-based strategy, which has great potential for adoption on a larger scale and thus high potential for reducing health disparities in the U.S.
- Conditions
- Inactivity
- Being tested
- Physical Activity Intervention, Wellness Control
- Keywords
- Physical Activity, Latinas, Web-based, Spanish-language
- 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.
Physical Activity InterventionBehavioural
Participants in the Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
Wellness ControlBehavioural
Participants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | Motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. Receives: Behavioral: Physical Activity Intervention |
| Wellness Control | Active comparator | Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. Receives: Behavioral: Wellness Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startDec 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dr.Bess Marcus, University of California, San Diego
- Investigators
- Bess H Marcus, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834287
- Sponsor's protocol ID
- Pasos Hacia La Salud
- Other IDs
- R01CA159954-02
- Status last verified
- Nov 2025
- First submitted
- 12 Apr 2013
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Larsen B, Dunsiger SI, Pekmezi D, Linke S, Hartman SJ, Marcus BH. Psychosocial mediators of physical activity change in a web-based intervention for Latinas. Health Psychol. 2021 Jan;40(1):21-29. doi: 10.1037/hea0001041. Epub 2020 Nov 23.
PubMed 33370154Hartman SJ, Pekmezi D, Dunsiger SI, Marcus BH. Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas. J Phys Act Health. 2020 Mar 1;17(3):343-348. doi: 10.1123/jpah.2019-0112.
PubMed 32035412Linke SE, Dunsiger SI, Gans KM, Hartman SJ, Pekmezi D, Larsen BA, Mendoza-Vasconez AS, Marcus BH. Association Between Physical Activity Intervention Website Use and Physical Activity Levels Among Spanish-Speaking Latinas: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e13063. doi: 10.2196/13063.
PubMed 31342902Marquez B, Norman GJ, Fowler JH, Gans KM, Marcus BH. Weight and weight control behaviors of Latinas and their social ties. Health Psychol. 2018 Apr;37(4):318-325. doi: 10.1037/hea0000597. Epub 2018 Feb 1.
PubMed 29389157Larsen B, Marcus B, Pekmezi D, Hartman S, Gilmer T. A Web-Based Physical Activity Intervention for Spanish-Speaking Latinas: A Costs and Cost-Effectiveness Analysis. J Med Internet Res. 2017 Feb 22;19(2):e43. doi: 10.2196/jmir.6257.
PubMed 28228368Marcus BH, Hartman SJ, Larsen BA, Pekmezi D, Dunsiger SI, Linke S, Marquez B, Gans KM, Bock BC, Mendoza-Vasconez AS, Noble ML, Rojas C. Pasos Hacia La Salud: a randomized controlled trial of an internet-delivered physical activity intervention for Latinas. Int J Behav Nutr Phys Act. 2016 May 28;13:62. doi: 10.1186/s12966-016-0385-7.
PubMed 27234302
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity in Latinas Via Interactive Web-Based Technology
- ClinicalTrials.gov ID
- NCT01834287
- Acronym / sponsor ID
- Pasos Hacia La Salud
- Conditions
- Inactivity
- Keywords
- Physical Activity, Latinas, Web-based, Spanish-language
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators are specifically targeting Latina women as they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions such as obesity, diabetes, or cardiovascular disease.
The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact Control condition. Participants are randomly assigned to one of two groups (Exercise and General Wellness).
The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants.
Detailed description
In the U.S., Latino women (Latinas) report higher rates of inactivity than their non-Hispanic White and male counterparts and thus are disproportionately burdened by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). Cultural factors, socioeconomic circumstances, language and educational barriers limit Latinas access to public health interventions that promote physically active lifestyles. To address this public health crisis, effective interventions that leverage state-of-the-art theory and methods are needed to reach this at-risk population. Our research group has over 20 years experience developing and evaluating individually-tailored, computer expert system-driven, physical activity interventions (based on Social Cognitive Theory and the Transtheoretical Model) through various channels and settings. In our recent pilot (R21NR009864), we culturally and linguistically adapted our tailored intervention for sedentary Latinas and conducted a small randomized trial of the modified program (N=93). A total of 81 participants completed the 6-month study (87% retention) and increased their physical activity from a mean of 17 minutes per week (SD=25.76) at baseline to 147 minutes (SD=241.55) at six months whereas contact control participants increased their physical activity from 12 minutes per week (SD=21.99) at baseline to 97 minutes (SD=118.49) at six months. These observed improvements in physical activity in our intervention group, along with high retention rates, participant-reported desire for an Internet-delivered program, and formative work developing our program in an Internet format lend support for testing an Internet intervention tailored to the needs of Latinas. Therefore, for the current proposal, we will build on our previous work by conducting an adequately powered (N=200) randomized controlled trial to test the efficacy of our culturally and linguistically modified, individually tailored physical activity intervention delivered via the Internet relative to an Internet wellness contact control condition (including cardiovascular health information developed for Latinos by the NHLBI). Data will be collected at baseline, 6 months (post-treatment), and 12 months (maintenance) using well-established physical activity measures (7-Day PAR, Actigraphs), as well as a comprehensive set of psychosocial questionnaires. We hypothesize that at end of treatment (month six) intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants. We will also examine the maintenance of treatment effects at 12 months, potential mediators and moderators of the intervention-physical activity relationship, and the costs of delivering the tailored Internet program. In the proposed study we seek to promote physical activity among an underserved population using a high-reach, low-cost, technology-based strategy, which has great potential for adoption on a larger scale and thus high potential for reducing health disparities in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Physical Activity InterventionMotivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. |
| Wellness Control | Active comparator | Behavioral: Wellness ControlInternet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Generally healthy (If asthma and/or high blood pressure, may be able to participate with physician consent)
- Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
- Latina (self-identified)
- Must be able to read and write Spanish fluently
Key exclusion criteria (28 listed)
- Pregnant or planning on becoming pregnant
- BMI greater than 45
- Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
- Exercise is against advice of doctor
- Heart disease/treatment
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 |
|---|---|---|
| Physical Activity InterventionParticipants in the Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. | Behavioural | Physical Activity Intervention |
| Wellness ControlParticipants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity. | Behavioural | Wellness Control |
Primary outcome
Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.
Time frame: Baseline, 6 months, and 12 months
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33370154Larsen B, Dunsiger SI, Pekmezi D, Linke S, Hartman SJ, Marcus BH. Psychosocial mediators of physical activity change in a web-based intervention for Latinas. Health Psychol. 2021 Jan;40(1):21-29. doi: 10.1037/hea0001041. Epub 2020 Nov 23.
- Derived from this study: PubMed 32035412Hartman SJ, Pekmezi D, Dunsiger SI, Marcus BH. Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas. J Phys Act Health. 2020 Mar 1;17(3):343-348. doi: 10.1123/jpah.2019-0112.
- Derived from this study: PubMed 31342902Linke SE, Dunsiger SI, Gans KM, Hartman SJ, Pekmezi D, Larsen BA, Mendoza-Vasconez AS, Marcus BH. Association Between Physical Activity Intervention Website Use and Physical Activity Levels Among Spanish-Speaking Latinas: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e13063. doi: 10.2196/13063.
- Derived from this study: PubMed 29389157Marquez B, Norman GJ, Fowler JH, Gans KM, Marcus BH. Weight and weight control behaviors of Latinas and their social ties. Health Psychol. 2018 Apr;37(4):318-325. doi: 10.1037/hea0000597. Epub 2018 Feb 1.
- Derived from this study: PubMed 28228368Larsen B, Marcus B, Pekmezi D, Hartman S, Gilmer T. A Web-Based Physical Activity Intervention for Spanish-Speaking Latinas: A Costs and Cost-Effectiveness Analysis. J Med Internet Res. 2017 Feb 22;19(2):e43. doi: 10.2196/jmir.6257.
- Derived from this study: PubMed 27234302Marcus BH, Hartman SJ, Larsen BA, Pekmezi D, Dunsiger SI, Linke S, Marquez B, Gans KM, Bock BC, Mendoza-Vasconez AS, Noble ML, Rojas C. Pasos Hacia La Salud: a randomized controlled trial of an internet-delivered physical activity intervention for Latinas. Int J Behav Nutr Phys Act. 2016 May 28;13:62. doi: 10.1186/s12966-016-0385-7.
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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
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity 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 8 inclusion and 28 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 25 Nov 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months. (time frame: Baseline, 6 months, and 12 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 NCT01834287, which also lists 6 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 25 Nov 2025.