An interventional study of Enhanced Physical Activity Intervention and Original Physical Activity Intervention in Inactivity, sponsored by Brown University. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
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).
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's enrollment of 210 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Enhanced Physical Activity Intervention
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).
Behavioral: Original Physical Activity Intervention
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.
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.
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.
Time frame: 6 months, 12, 18 and 24 months
Self-reported Min/Week MVPA
Self-reported minutes/week of at least moderate intensity physical activity as collected via the 7-day PAR
Time frame: 6, 12, 18, 24 months
| Milestone | Enhanced Physical Activity Intervention | Original Physical Activity Intervention |
|---|---|---|
| Started | 103 | 92 |
| Completed | 92 | 66 |
| Not completed | 11 | 26 |
For the week prior to each assessment, participants will wear an Actigraph GT3X+ accelerometer which collects min/week of objectively measured MVPA.
| min/week | Enhanced Physical Activity Intervention | Original Physical Activity Intervention |
|---|---|---|
| 6 months | 46.90 ± 66.26 | 42.87 ± 78.18 |
| 12 months | 44.50 ± 59.32 | 55.89 ± 105.95 |
| 18 months | 48.67 ± 79.32 | 31.58 ± 53.55 |
| 24 months | 47.44 ± 89.97 | 31.22 ± 47.35 |
Self-reported minutes/week of at least moderate intensity physical activity as collected via the 7-day PAR
| min/week | Enhanced Physical Activity Intervention | Original Physical Activity Intervention |
|---|---|---|
| 6 months | 114.97 ± 119.63 | 87.88 ± 115.22 |
| 12 months | 106.75 ± 114.88 | 111.68 ± 149.90 |
| 18 months | 103.00 ± 93.46 | 80.90 ± 90.14 |
| 24 months | 135.30 ± 125.12 | 93.92 ± 85.22 |
Collected over Baseline to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Physical Activity Intervention | 0/103 (0%) | 0/103 (0%) | 0/103 (0%) |
| Original Physical Activity Intervention | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
N=210 were randomized but 15 were deemed ineligible post randomization. The final analytic sample was N=195.
| Age, Continuous(years) | Enhanced Physical Activity Intervention | Original Physical Activity Intervention | Total |
|---|---|---|---|
| Mean | 42.93 ± 10.17 | 43.73 ± 10.47 | 43.31 ± 10.29 |
| Sex: Female, Male(Participants) | Enhanced Physical Activity Intervention | Original Physical Activity Intervention | Total |
|---|---|---|---|
| Female | 103 | 92 | 195 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Enhanced Physical Activity Intervention | Original Physical Activity Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 103 | 92 | 195 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Min/Week of At least Moderate Intensity Physical Activity (MVPA) as measured via accelerometer(Min/Week) | Enhanced Physical Activity Intervention | Original Physical Activity Intervention | Total |
|---|---|---|---|
| Mean | 19.70 ± 47.93 | 20.57 ± 42.69 | 20.11 ± 45.40 |
| Min/Week of At least Moderate Intensity Physical Activity (MVPA) as measured via self-report(min/week) | Enhanced Physical Activity Intervention | Original Physical Activity Intervention | Total |
|---|---|---|---|
| Mean | 55.28 ± 262.07 | 52.43 ± 150.27 | 53.94 ± 216.11 |
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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