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| ID | Type | Description | Link |
|---|---|---|---|
| 5K01MD013910 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Posttraumatic stress disorder (PTSD) is a major public health concern that disproportionately effects minorities and those with low-socioeconomic status, such as homeless women, creating a critical health disparity. PTSD has been linked with dysregulated hypothalamic-pituitary-adrenal (HPA) functioning and increased inflammation, which can lead to long-term physical-health problems and PTSD-symptom maintenance, exacerbating disparities. Mindfulness-based interventions, including Mindfulness-based Stress Reduction (MBSR), have shown promise as a complementary tool for addressing PTSD in veterans and with low-income, minority populations, but homeless women have not been examined adequately. MBSR may improve PTSD symptomatology and help modulate the dysregulated stress response common in individuals with PTSD, improving physical and mental health concurrently. This project is an open-label, parallel, modified-cross over clinical trial of a modified-MBSR intervention to reduce PTSD symptoms in homeless women and to explore physiological correlates of treatment-response.
Hypotheses:
At baseline, women will complete psychosocial assessments (e.g., depression, substance use, trauma history) and participate in a brief stress task, providing salivary samples before and after the task (which will be assayed for cortisol and C-reactive protein, a marker of inflammation). Women will then participate in 1) a 9-session MBSR-based program that was modified based on an initial qualitative component that involved a Community Advisory Board and focus groups with women from the community (N=4 focus groups; 28 women total) or 2) a nine-session health-promotion course (i.e., attention-control condition). Follow-up assessments that include psychosocial and biological data will occur immediately after final intervention session and again 6-months later. Clinically-meaningful improvements in PTSD (primary outcome) and secondary outcomes (e.g., depression, substance use, inflammation, cortisol reactivity) will be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Experimental |
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| Health Promotion Attention Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Mindfulness-based Stress Reduction | Behavioral | Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Change in Posttraumatic Stress Symptoms Disorder symptoms (i.e., decrease in symptoms), as measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). The PCL-5 is a 20-item scale (range 0-80), with rating scale descriptions: 0 "Not at all," 1 "A little bit," 2 "Moderately," 3 "Quite a bit," and 4 "Extremely." Higher scores indicate more PTSD symptoms. | Immediately post-intervention & 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Change in depressive symptoms from baseline to follow-ups (i.e., decrease in symptoms), using the Patient Reported Outcomes Measurement Information System (PROMIS) measure for depression. The PROMIS asks 9-items (range 9-45) with response options: 1 "never", 2 "rarely", 3 "sometimes", 4 "often", and 5 "always". Higher scores indicate more symptoms of depression. | Immediately post-intervention & 6-month follow-up |
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Inclusion Criteria:
Note: A homeless person is defined as anyone who spent the previous night in a public or private shelter, or on the street.
Exclusion Criteria:
Only women are eligible for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North County Serenity House | Escondido | California | 92026 | United States | ||
| Prototypes Women's Center |
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192 participants were assessed for eligibility. Of those, 13 did not experience homelessness, 10 were cognitively impaired, 3 did not meet criteria for subthreshold PTSD, and 10 were eligible but did not enroll.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Mindfulness-based Stress Reduction (MBSR) | Modified Mindfulness-based Stress Reduction (MBSR): Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 1, 2022 |
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Participants will be recruited from two sites. To avoid contamination between subjects living at the sites, using a quasi-randomized method, all participants at each site will receive the same treatment per cohort. Sites will alternate between the assignment of treatment (modified-MBSR) or control (health promotion class) in sequential cohorts to account for between site differences.
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| Health Promotion Wellness Classes | Behavioral | Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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| Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5) | Change in continues measure of self-report substance use from baseline to follow-ups using the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5). The possible range for the score is 1-11. Participants respond to a series of 13 possible no (0) or yes (1) questions, with two questions counting for a maximum score of "1" each. Higher scores indicate more severe substance use. | Immediately post-intervention & 6-month follow-up |
| Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Count of participants with positive substance use from baseline to follow-up using 5-panel FDA-approved urine test cup. | Immediately post-intervention & 6-month follow-up |
| Cortisol Reactivity | Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics). Higher scores indicate more change in cortisol. | Immediately post-intervention & 6-month follow-up |
| C-Reactive Protein (CRP) | Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. Higher scores indicate higher concentration of CRP. | Immediately post-intervention & 6-month follow-up |
| Pomona |
| California |
| 91767 |
| United States |
| FG001 | Health Promotion Attention Control (HP Control) | Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Mindfulness-based Stress Reduction | Modified Mindfulness-based Stress Reduction: Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review. |
| BG001 | Health Promotion Attention Control | Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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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/Ethnicity, Customized | Count of Participants | Participants |
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| Posttraumatic Stress Disorder Checklist for Diagnostic & Statistical Manual of Mental Disorders, 5th | The Posttraumatic Stress Disorders Checklist for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (PCL-5) first identifies prior direct exposure to a DSM-V traumatic event. Then, twenty items assess all four B-E criteria (re-experiencing, avoidance, negative thoughts or cognitions, hyperarousal), on scale from 0=not at all to 4=extremely. The range of symptoms is 0-80. Thirty-three is generally considered the cutpoint for probable-PTSD. | Mean | Standard Deviation | units on a scale |
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| Mean PROMIS Depression | The Patient-Reported Outcomes Measurement Information System (PROMIS), Depression, Short Form assesses frequency of eight symptoms of depression in the past seven days from 1=never to 5=always. The range is 8-40. | Mean | Standard Deviation | units on a scale |
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| Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety | The Patient-Reported Outcomes Measurement Information System (PROMIS), Anxiety Short Form assesses frequency of seven symptoms of anxiety in the past seven days from 1=never to 5=always. The range is 7-35. | Mean | Standard Deviation | units on a scale |
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| Substance Use - Texas Christian University Drug Screen | The Texas Christian University Drug Screen (TCU Drug Screen 5) is a 19-item screener for Diagnostic and Statistical Manual of Mental Disorders criteria substance use disorder. For the first 13 items, participants indicate 0=no or 1=yes. To score, assign 1 point to each "yes" response to items 1 through 9. For items 10 and 11, a. assign 1 point if respondent answers "yes" to either 10a or 10b; b. assign 1 point if respondent answers "yes" to either 11a or 11b. 3. Sum 1-point "yes" responses for items 1 to11, yielding a total score range 0 to 11. The remaining items are not scored. | Mean | Standard Deviation | units on a scale |
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| Substance use, 5-panel test | 5-panel substance use urine test (tests for amphetamine, cocaine, methamphetamine, opioids, and THC), coded 0=no drugs in urine, 1=at least one substance in urine | Count of Participants | Participants |
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| C-Reactive Protein (CRP) | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) |
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| Cortisol reactivity | At baseline, participants engaged in a stress task (trauma script imagery test). Participants provided cortisol samples via passive saliva drool before and then twenty minutes post-task. Baseline cortisol reactivity was calculated by subtracting pre-task cortisol from the post-task cortisol. To collect saliva, participants passively drooled into a collection vial for three minutes or until 0.80 milliliters of fluid was collected. Saliva samples were immediately placed in the on-site freezer and subsequently frozen at -80°C until assayed | Some data was contaminated or did not have adequate volume for analyses, thus 144 rather than 156 observations were available. | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Post-traumatic Stress Symptoms (PTSD) as Measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). | Change in Posttraumatic Stress Symptoms Disorder symptoms (i.e., decrease in symptoms), as measured by the PTSD Checklist for DSM 5 (PCL-5) (DSM=Diagnostic and Statistical Manuel of Mental Disorders). The PCL-5 is a 20-item scale (range 0-80), with rating scale descriptions: 0 "Not at all," 1 "A little bit," 2 "Moderately," 3 "Quite a bit," and 4 "Extremely." Higher scores indicate more PTSD symptoms. | The total number analyzed for Time 2 (immediate post-intervention follow-up) was 125. The total number analyzed for Time 3 was 86. The numbers differ due to attrition over time. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-intervention & 6-month follow-up |
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| Secondary | Depression | Change in depressive symptoms from baseline to follow-ups (i.e., decrease in symptoms), using the Patient Reported Outcomes Measurement Information System (PROMIS) measure for depression. The PROMIS asks 9-items (range 9-45) with response options: 1 "never", 2 "rarely", 3 "sometimes", 4 "often", and 5 "always". Higher scores indicate more symptoms of depression. | The total number analyzed for Time 2 (immediate post-intervention follow-up) was 126. The total number analyzed for Time 3 was 86. The numbers differ due to attrition over time. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-intervention & 6-month follow-up |
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| Secondary | Substance Use Measured by the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5) | Change in continues measure of self-report substance use from baseline to follow-ups using the Texas Christian University Screen for Diagnostic and Statistical Manuel of Mental Disorders, 5th Edition (TCU 5). The possible range for the score is 1-11. Participants respond to a series of 13 possible no (0) or yes (1) questions, with two questions counting for a maximum score of "1" each. Higher scores indicate more severe substance use. | The total number analyzed for Time 2 (immediate post-intervention follow-up) was 119. The total number analyzed for Time 3 was 86. The numbers differ due to attrition and missing data over time. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-intervention & 6-month follow-up |
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| Secondary | Number of Participants With Positive Substance Use Measured by a 5-panel FDA-approved Urine Test Cup | Count of participants with positive substance use from baseline to follow-up using 5-panel FDA-approved urine test cup. | The total number analyzed for Time 2 (immediate post-intervention follow-up) was 118. The total number analyzed for Time 3 was 79. The numbers differ due to attrition and missing data over time. | Posted | Count of Participants | Participants | Immediately post-intervention & 6-month follow-up |
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| Secondary | Cortisol Reactivity | Change in cortisol reactivity using script driven imagery from baseline to follow-up using standard manufacturer protocols (from Salimetrics). Higher scores indicate more change in cortisol. | The total number analyzed for Time 2 (immediate post-intervention follow-up) was 118. The total number analyzed for Time 3 was 76. The numbers differ due to attrition and missing data over time. | Posted | Mean | Standard Deviation | Micrograms per deciliter (µg/dL) | Immediately post-intervention & 6-month follow-up |
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| Secondary | C-Reactive Protein (CRP) | Change in CRP, measured via saliva using the Salivary C-Reactive Protein ELISA kit, an enzyme-linked immunoassay. Higher scores indicate higher concentration of CRP. | The total number analyzed for Time 2 (immediate post-intervention follow-up) was 121. The total number analyzed for Time 3 was 80. The numbers differ due to attrition and missing data over time. | Posted | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | Immediately post-intervention & 6-month follow-up |
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Adverse event data was collected during the duration of the intervention procedures (approximately 8 weeks).
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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) |
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| EG000 | Modified Mindfulness-based Stress Reduction | Modified Mindfulness-based Stress Reduction: Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review. | 0 | 90 | 0 | 90 | 0 | 90 |
| EG001 | Health Promotion Attention Control | Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. | 0 | 66 | 0 | 66 | 0 | 66 |
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Participants were not assigned on a 1:1 ratio. Some courses lasted more than 8 weeks due to vacillating quarantines and lockdowns during COVID-19 outbreaks. Relatedly, participants who were discharged from the site were not allowed to participate in follow-up sessions due to COVID-19 quarantines in 2020-2021, contributing to increased attrition over time. Additional MBSR participants were enrolled to adjust for this, allowing for adequate power but resulting in an unbalanced design.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dana Rose Garfin, Associate Professor | University of California, Los Angeles | 415-407-9498 | dgarfin@ucla.edu |
| Nov 19, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2021 | Apr 16, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
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| Black/African American |
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| Hispanic |
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| Mixed identity |
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| Native American/Pacific Islander |
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| Time 3 (6-month follow-up) |
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| OG001 |
| Health Promotion Attention Control |
Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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| OG001 | Health Promotion Attention Control | Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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Health Promotion Wellness Classes: Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation. |
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