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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA159954-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wellness Control | Active Comparator | Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bess H Marcus, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33370154 | Derived | 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. | |
| 32035412 | Derived | Hartman 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Intervention | Motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. |
| FG001 | Wellness Control | Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
205 eligible participants (13 ineligible post-randomization were removed from analysis)
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Intervention | Motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. |
| BG001 | Wellness Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes/week | Baseline, 6 months, and 12 months |
|
baseline through 12m
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Activity Intervention | Motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bess Marcus | Brown University | 4018636850 | bess_marcus@brown.edu |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Wellness Control | Behavioral | Participants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity. |
|
| 31342902 | Derived | Linke 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. |
| 29389157 | Derived | Marquez 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. |
| 28228368 | Derived | Larsen 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. |
| 27234302 | Derived | Marcus 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. |
Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self-reported Ethnicity | Count of Participants | Participants |
|
| OG001 | Wellness Control | Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. |
|
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 0 |
| 104 |
| EG001 | Wellness Control | Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity. | 0 | 101 | 0 | 101 | 0 | 101 |
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