InactivityNCT03491592
Web-based Physical Activity Intervention for Latinas
A study testing Enhanced Physical Activity Intervention and Original Physical Activity Intervention in people with Inactivity, run by Brown University at 1 site in United States.
Trial summary
This renewal builds upon our successful culturally adapted PA intervention for Latinas (Pasos Hacia La Salud, R01CA159954) and expands its focus to the critical area of maintenance of behavior change. 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?
- Enhanced Physical Activity Intervention and Original Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Apr 2022
- 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)
- Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
- Daily access to a text-message compatible cell phone and to an Internet-connected device through home, work, or their community
Who cannot join
- History of coronary heart disease (history of myocardial infarction or symptoms of angina),
- Diabetes that requires insulin and does not have a doctor's approval
- Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
- Orthopedic conditions which limit mobility, any other serious medical condition that would make PA unsafe (based on modified Physical Activity Readiness Questionnaire)
- Hospitalization due to a psychiatric disorder in the past 3 years
- BMI above 45 kg/m2
Show all 10Show fewer
- Current or planned pregnancy in the next two year
- Moving from area within two years
- Does not have a cellphone capable of sending and receiving text messages
- Not able to receive materials in the mail, either at your own home or at a mailbox
Trial locations and contacts
1 site in 1 country.
United States1 site
121 South Main Street, Brown University
Providence, Rhode Island, 02912
About this study
Official title: Promoting Physical Activity in Latinas Via Interactive Web-based Technology
This renewal builds upon our successful culturally adapted PA intervention for Latinas (Pasos Hacia La Salud, R01CA159954) and expands its focus to the critical area of maintenance of behavior change. This study will test an enhanced version of the original internet intervention in order to achieve greater increases in PA and longer term maintenance. Investigators propose to test this newly developed enhanced intervention (Enhanced Intervention) compared to the original Pasos Hacia La Salud Intervention (Original Intervention) in a 24-month randomized trial (N=300).
Read the detailed description
In the U.S., Latina women report higher rates of inactivity than their non-Hispanic White and male counterparts, and are disproportionately affected by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). To address this public health crisis, evidence-based interventions that utilize state-of-the-art technology, theory and methods are needed to increase physical activity (PA) among this high-risk population. Recently, our team conducted a randomized controlled trial (N=205) to test the efficacy of a 6-month culturally adapted, individually tailored, Spanish-language Internet-based PA intervention among Latinas (Pasos Hacia La Salud, R01CA159954) vs. a Wellness Contact Control Internet Group. Increases in minutes/week of moderate-to-vigorous physical activity (MVPA) were significantly greater in the Intervention Group compared to the Control Group at 6 and 12 months (p < .01) but still did not reach levels recommended in the national physical activity guidelines. As improvements in PA in the Intervention Group were significantly associated with website use and increases in self-efficacy, enjoyment, and social support in the parent study, we used these data to inform technology and theory-supported enhancements to the intervention (i.e., text messaging and adaptive goal setting to increase website use and further targeting of the previously mentioned key psychosocial constructs) to achieve even greater increases in PA, and maintain these gains over the long term (24 months) in the renewal of R01CA159954. For the proposed study, 300 Latina women will be randomized to either 1) the original Pasos Hacia La Salud tailored Internet-based PA intervention (Original Intervention) or 2) the data driven, enhanced version of the Pasos Hacia La Salud PA intervention (Enhanced Intervention). We hypothesize that participants in the Enhanced Intervention arm will report significantly more minutes/week of MVPA than participants in the Original Intervention arm at 6 months. We will also examine the maintenance of treatment effects at 12, 18, and 24 months, as well as the costs of delivering the Enhanced vs. Original Intervention programs, and the potential mediators of the intervention-PA relationship. The proposed high reach, low-cost intervention holds great promise in promoting and maintaining the positive health benefits of PA in the lives of Latina women in the United States.
- Conditions
- Inactivity
- Being tested
- Enhanced Physical Activity Intervention, Original Physical Activity Intervention
- Keywords
- Physical Activity, Latinas, Spanish-language, Text-Message, Exercise, Web-based
- 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.
Enhanced Physical Activity InterventionBehavioural
Participants in the Enhanced Intervention arm will receive all the intervention components of the Original Intervention described above plus: 1) text messages and adaptive goal-setting to drive participants back to the website and keep them there longer, and 2) data-driven, technology supported enhanced intervention content targeting theoretical constructs that influenced PA behavior in Latinas from the parent study.
Original Physical Activity InterventionBehavioural
Participants in the Original Physical Activity intervention arm of the study will receive the original Spanish language, motivationally-tailored, Internet-based physical activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Physical Activity Intervention | Experimental | A data driven enhanced Pasos Hacia La Salud intervention based on results and participant feedback from the motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention in the parent study. Receives: Behavioral: Enhanced Physical Activity Intervention |
| Original Physical Activity Intervention | Active comparator | The original Internet-based program is a computer expert system-driven, individually tailored Spanish language intervention, guided by Social Cognitive Theory (SCT) and the Transtheoretical Model (TTM). Receives: Behavioral: Original Physical Activity Intervention |
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 an Accelerometer at 6 Months, 12 Months and 18 Months
For the week prior to each assessment, participants will wear an Actigraph GT3X+ accelerometer which collects min/week of objectively measured MVPA.
Measured: 6 months, 12, 18 and 24 months
Secondary outcomes (1)
Self-reported Min/Week MVPA
Self-reported minutes/week of at least moderate intensity physical activity as collected via the 7-day PAR
Measured: 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jun 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 (4)Papers the sponsor has linked to this study.
- Other trials for InactivityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bess Marcus, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491592
- Sponsor's protocol ID
- R01CA159954
- Other IDs
- R01CA159954
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2018
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larsen B, Pekmezi D, Hartman SJ, Dunsiger S, Gilmer T, Groessl E, Marcus B. Costs and Cost-Effectiveness at 12 and 24 Months of an Enhanced Web-Based Physical Activity Intervention for Latina Adults: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Nov 25;27:e76739. doi: 10.2196/76739.
PubMed 41289583Connell Bohlen L, Dunsiger SI, von Ash T, Larsen BA, Pekmezi D, Marquez B, Benitez TJ, Mendoza-Vasconez A, Hartman SJ, Williams DM, Marcus BH. Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial. J Med Internet Res. 2024 Jun 6;26:e51708. doi: 10.2196/51708.
PubMed 38842930von Ash T, Dunsiger SI, Williams DM, Larsen BA, Bohlen LC, Pekmezi D, Mendoza-Vasconez AS, Benitez TJ, Bock BC, Hartman SJ, Marquez B, Marcus BH. Pasos Hacia La Salud II: A Superiority RCT Utilizing Technology to Promote Physical Activity in Latinas. Am J Prev Med. 2024 Aug;67(2):220-230. doi: 10.1016/j.amepre.2024.03.006. Epub 2024 Mar 13.
PubMed 38490284Mendoza-Vasconez AS, Benitez T, Dunsiger S, Gans KM, Hartman SJ, Linke SE, Larsen BA, Pekmezi D, Marcus BH. Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention. Trials. 2022 Aug 1;23(1):621. doi: 10.1186/s13063-022-06575-4.
PubMed 35915473
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. 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
- NCT03491592
- Acronym / sponsor ID
- R01CA159954
- Conditions
- Inactivity
- Keywords
- Physical Activity, Latinas, Spanish-language, Text-Message, Exercise, Web-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This renewal builds upon our successful culturally adapted PA intervention for Latinas (Pasos Hacia La Salud, R01CA159954) and expands its focus to the critical area of maintenance of behavior change. This study will test an enhanced version of the original internet intervention in order to achieve greater increases in PA and longer term maintenance. Investigators propose to test this newly developed enhanced intervention (Enhanced Intervention) compared to the original Pasos Hacia La Salud Intervention (Original Intervention) in a 24-month randomized trial (N=300).
Detailed description
In the U.S., Latina women report higher rates of inactivity than their non-Hispanic White and male counterparts, and are disproportionately affected by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). To address this public health crisis, evidence-based interventions that utilize state-of-the-art technology, theory and methods are needed to increase physical activity (PA) among this high-risk population. Recently, our team conducted a randomized controlled trial (N=205) to test the efficacy of a 6-month culturally adapted, individually tailored, Spanish-language Internet-based PA intervention among Latinas (Pasos Hacia La Salud, R01CA159954) vs. a Wellness Contact Control Internet Group. Increases in minutes/week of moderate-to-vigorous physical activity (MVPA) were significantly greater in the Intervention Group compared to the Control Group at 6 and 12 months (p < .01) but still did not reach levels recommended in the national physical activity guidelines. As improvements in PA in the Intervention Group were significantly associated with website use and increases in self-efficacy, enjoyment, and social support in the parent study, we used these data to inform technology and theory-supported enhancements to the intervention (i.e., text messaging and adaptive goal setting to increase website use and further targeting of the previously mentioned key psychosocial constructs) to achieve even greater increases in PA, and maintain these gains over the long term (24 months) in the renewal of R01CA159954. For the proposed study, 300 Latina women will be randomized to either 1) the original Pasos Hacia La Salud tailored Internet-based PA intervention (Original Intervention) or 2) the data driven, enhanced version of the Pasos Hacia La Salud PA intervention (Enhanced Intervention). We hypothesize that participants in the Enhanced Intervention arm will report significantly more minutes/week of MVPA than participants in the Original Intervention arm at 6 months. We will also examine the maintenance of treatment effects at 12, 18, and 24 months, as well as the costs of delivering the Enhanced vs. Original Intervention programs, and the potential mediators of the intervention-PA relationship. The proposed high reach, low-cost intervention holds great promise in promoting and maintaining the positive health benefits of PA in the lives of Latina women in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Physical Activity Intervention | Experimental | Behavioral: Enhanced Physical Activity InterventionA data driven enhanced Pasos Hacia La Salud intervention based on results and participant feedback from the motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention in the parent study. |
| Original Physical Activity Intervention | Active comparator | Behavioral: Original Physical Activity InterventionThe original Internet-based program is a computer expert system-driven, individually tailored Spanish language intervention, guided by Social Cognitive Theory (SCT) and the Transtheoretical Model (TTM). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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)
- Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau
- Must be able to read and write Spanish fluently
Key exclusion criteria (10 listed)
- History of coronary heart disease (history of myocardial infarction or symptoms of angina),
- Diabetes that requires insulin and does not have a doctor's approval
- Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
- Orthopedic conditions which limit mobility, any other serious medical condition that would make PA unsafe (based on modified Physical Activity Readiness Questionnaire)
- Hospitalization due to a psychiatric disorder in the past 3 years
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 |
|---|---|---|
| Enhanced Physical Activity InterventionParticipants in the Enhanced Intervention arm will receive all the intervention components of the Original Intervention described above plus: 1) text messages and adaptive goal-setting to drive participants back to the website and keep them there longer, and 2) data-driven, technology supported enhanced intervention content targeting theoretical constructs that influenced PA behavior in Latinas from the parent study. | Behavioural | Enhanced Physical Activity Intervention |
| Original Physical Activity InterventionParticipants in the Original Physical Activity intervention arm of the study will receive the original Spanish language, motivationally-tailored, Internet-based physical activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. | Behavioural | Original Physical Activity Intervention |
Primary outcome
Total Weekly Minutes of Physical Activity as Measured by an Accelerometer at 6 Months, 12 Months and 18 Months
Time frame: 6 months, 12, 18 and 24 months
For the week prior to each assessment, participants will wear an Actigraph GT3X+ accelerometer which collects min/week of objectively measured MVPA.
1 secondary outcome
Self-reported Min/Week MVPA
Time frame: 6, 12, 18, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41289583Larsen B, Pekmezi D, Hartman SJ, Dunsiger S, Gilmer T, Groessl E, Marcus B. Costs and Cost-Effectiveness at 12 and 24 Months of an Enhanced Web-Based Physical Activity Intervention for Latina Adults: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Nov 25;27:e76739. doi: 10.2196/76739.
- Derived from this study: PubMed 38842930Connell Bohlen L, Dunsiger SI, von Ash T, Larsen BA, Pekmezi D, Marquez B, Benitez TJ, Mendoza-Vasconez A, Hartman SJ, Williams DM, Marcus BH. Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial. J Med Internet Res. 2024 Jun 6;26:e51708. doi: 10.2196/51708.
- Derived from this study: PubMed 38490284von Ash T, Dunsiger SI, Williams DM, Larsen BA, Bohlen LC, Pekmezi D, Mendoza-Vasconez AS, Benitez TJ, Bock BC, Hartman SJ, Marquez B, Marcus BH. Pasos Hacia La Salud II: A Superiority RCT Utilizing Technology to Promote Physical Activity in Latinas. Am J Prev Med. 2024 Aug;67(2):220-230. doi: 10.1016/j.amepre.2024.03.006. Epub 2024 Mar 13.
- Derived from this study: PubMed 35915473Mendoza-Vasconez AS, Benitez T, Dunsiger S, Gans KM, Hartman SJ, Linke SE, Larsen BA, Pekmezi D, Marcus BH. Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention. Trials. 2022 Aug 1;23(1):621. doi: 10.1186/s13063-022-06575-4.
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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 study testing Enhanced Physical Activity Intervention and Original Physical Activity Intervention in people with Inactivity, run by Brown 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 7 inclusion and 10 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 18 Aug 2026. 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 18 Aug 2026). 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 an Accelerometer at 6 Months, 12 Months and 18 Months (time frame: 6 months, 12, 18 and 24 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 NCT03491592, which also lists 4 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 18 Aug 2026.