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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR014911 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The aim of this study is to build upon our tailored print intervention by developing new text-delivered intervention materials to complement our print-based physical activity (PA) intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American (MA) men to determine content, frequency, and types of text messages desired, and to identify cultural themes to incorporate into existing and new materials. Themes from the focus groups and sample text messages will be presented to a confirmatory focus group panel. Phase 2 will be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the text-enhanced, Spanish language, individually tailored PA intervention vs. publicly available, Spanish language health education materials, including information on PA, diet, and stress management. This will be followed by post-intervention qualitative interviews to solicit suggestions for improvements to help further refine the program. The proposed pilot will support a future R01 to establish the efficacy of this multi-media, multi-level PA intervention for Mexican and MA men.
The proposed research addresses serious public health concerns (inactivity, health disparities) in a large, rapidly growing population of Mexican American (MA) men who are markedly less physically active than men of other ethnicities and suffer from higher prevalence of conditions related to sedentary lifestyle. While this population is clearly in need of physical activity (PA) interventions, to date none have specifically targeted MA men. In fact, the majority of PA interventions for Latinos have exclusively included women and/or are designed around female preferences.The proposed study will address the needs and barriers to PA in MA men by developing text message-delivered intervention materials based on Social Cognitive Theory (SCT) to complement an individually tailored, theory-based print material PA intervention for Spanish speaking Mexican and MA men. Text messaging could be a particularly effective and appealing channel for increasing PA in this target population as it allows for participant interaction, real-time accountability, and immediate feedback, features which MA men in the demonstration trial of our print intervention specifically requested. Text-based interventions have been shown to improve a number of health behaviors, including PA. A recent review of texting interventions found that they were generally well received and effective in reducing inactivity, weight, and waist circumference,5 and a meta-analysis found a moderate effect size (g = 0.54) for using mobile devices to increase PA. However, few of these trials targeted underserved populations, and none specifically targeted Latinos. Cell phone ownership is high in Latino adults (86% vs. 84% in non-Latino Whites), and Latinos are actually the most likely to use mobile phones for text messaging, with 85% reporting regularly sending and receiving texts (compared to 79% of Whites). Thus this is a familiar, convenient channel for delivering new intervention materials. Additionally, as Latinos also face environmental barriers to PA, in the current proposal we will enhance the individually tailored psychosocial print-based materials by developing materials targeting barriers in home and work environments. This multi-media, multi-level approach has potential for broad reach at relatively low cost, which could help reduce health disparities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text-Enhanced Physical Activity Intervention Arm | Experimental | The Spanish-language PA intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals). |
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| Health Education Control Arm | Active Comparator | The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text-Enhanced Physical Activity Intervention Arm | Behavioral | Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men. |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+ | Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure. | Baseline and 6 months |
| Self Reported Min/Week of MVPA | Self reported physical activity (collected via 7 day PAR) | baseline and 6 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 | 92093-0628 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32448552 | Derived | Larsen BA, Benitez TJ, Mendoza-Vasconez AS, Hartman SJ, Linke SE, Pekmezi DJ, Dunsiger SI, Nodora JN, Gans KM, Marcus BH. Randomized Trial of a Physical Activity Intervention for Latino Men: Activo. Am J Prev Med. 2020 Aug;59(2):219-227. doi: 10.1016/j.amepre.2020.03.007. Epub 2020 May 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text-Enhanced Physical Activity Intervention Arm | The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals). Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men. Actigraph GT3X |
| FG001 | Health Education Control Arm | The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management. Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity. Actigraph GT3X |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Two participants were randomized never started and thus removed from subsequent analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Text-Enhanced Physical Activity Intervention Arm | The Spanish-language Physical Activity intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals). Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men. Actigraph GT3X |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+ | Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure. | Posted | Median | Inter-Quartile Range | minutes/week | Baseline and 6 months |
|
28 months (first baseline visit to last 6 month visit)
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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 | Text-Enhanced Physical Activity Intervention Arm | The Spanish-language PA intervention is based on SCT and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting PA goals). Text-Enhanced Physical Activity Intervention Arm: Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men. Actigraph GT3X |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bess Marcus | Brown University | 401-863-9858 | bess_marcus@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2018 | Jun 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Health Education Control Arm | Behavioral | Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity. |
|
| Actigraph GT3X | Device |
|
| BG001 | Health Education Control Arm | The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management. Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity. Actigraph GT3X |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Objectively Measured Physical Activity | Baseline objectively measured physical activity of at least moderate intensity (MVPA) collected via accelerometer | Median | Inter-Quartile Range | minutes/week |
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| Self-Reported Physical Activity | Subjectively reported baseline minutes of at least moderate intensity physical activity (MVPA) as reported on the 7 day physical activity recall (PAR) | Median | Inter-Quartile Range | minutes/week |
|
| OG001 | Health Education Control Arm | The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management. Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity. Actigraph GT3X |
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|
|
| Primary | Self Reported Min/Week of MVPA | Self reported physical activity (collected via 7 day PAR) | Posted | Median | Inter-Quartile Range | min/week | baseline and 6 months |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Health Education Control Arm | The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management. Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity. Actigraph GT3X | 0 | 24 | 0 | 24 | 0 | 24 |
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