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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NR011295 | 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 overall goals of this renewal are to replicate the findings of Seamos Saludables in Latina women, increase the effectiveness of the intervention, and measure intervention-related changes in clinical biomarkers. We will enhance the existing intervention by incorporating participant feedback (desire for greater interactivity and accountability), further targeting Social Cognitive Theory (SCT) constructs that were not influenced overall by the original intervention yet improved amongst our most successful participants (social support, outcome expectancies), and responding to changing trends and technology use in Latinos. We will conduct a clinical trial among Latina women in California randomized to either 1) the original Seamos Saludables tailored print only intervention or 2) a theory and text messaging-enhanced interactive technology based version of the Seamos Saludables intervention. We will also measure changes in cardiovascular and metabolic biomarkers (e.g., HbA1c, and LDL) to assess potential clinical impact of the intervention.
Latinos are the largest racial/ethnic minority group in the U.S., and report substantial and widening health disparities. Prevalence of type II diabetes is 60-100% higher in Latinos than in non-Latino Whites, and incidence in Latinos is projected to increase by 500% by 20503. The largest disparities are projected for Latino women (Latinas). Rates of overweight and obesity are 23% and 37% higher in Latinas than in White women respectively, and have grown faster in Mexican American women, by far the largest subgroup of Latinas, than in White women during the past decade. Given that Latinos are projected to comprise nearly one-third of the US population by 2050, this signifies a pressing public health concern in terms of costs, diminished quality of life, and lost life years. Interventions are therefore needed that are not only linguistically adapted for this population but address their specific barriers. "Mediated" intervention delivery approaches (e.g., mail, phone, or web delivered) that emphasize home-based, lifestyle activities show larger effect sizes than face-to-face approaches, are more cost-effective, are likely more sustainable, and may be particularly appropriate for Latinas, as they reduce the burden of time, childcare, and transportation, barriers commonly cited by Latinas. Thus in the previously funded parent grant (R01NR011295) we responded to PAR-07-379, "Behavioral and Social Science Research on Understanding and Reducing Health Disparities," by modifying an existing print-based mail-delivered PA intervention and adapting it specifically for Latinas in the North Eastern U.S. with low acculturation, literacy, and socioeconomic status (SES), and testing the modified intervention in a randomized controlled trial (N=266). Participants in the PA intervention arm showed significantly greater increases in at least moderate intensity activity, increasing from 1.87 min/week at baseline to 73.36 min/week at 6 months (vs. 3.02 min/week to 32.98 min/week in a contact control group). However, this is still well below the national guidelines of 150 minutes per week. This intervention therefore shows potential in promoting initial PA adoption, yet enhancements are needed to further help people achieve levels of PA that will prevent disease and reduce health disparities. The objectives of this renewal are to 1) enhance the intervention to achieve greater increases in PA, 2) assess its potential clinical impact by measuring changes in biomarkers, and 3) increase its generalizability by replicating it in Latina women, all of which would further the goal of designing an innovative behavioral intervention to promote health and prevent illness in diverse populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Original Tailored Intervention | Active Comparator | This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals). |
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| Enhanced Tailored Intervention | Experimental | We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Original Tailored Intervention | Behavioral | The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Accelerometer Measured Moderate to Vigorous PA (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, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. |
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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 |
|---|---|---|---|
| 37208924 | Derived | Larsen B, Gilmer T, Pekmezi D, Hartman SJ, Benitez T, Rabin B, Marcus BH, Mendoza-Vasconez AS, Groessl EJ. Cost effectiveness of a technology-enhanced physical activity intervention for Latinas. Transl Behav Med. 2023 Sep 12;13(9):675-682. doi: 10.1093/tbm/ibad021. | |
| 34379236 | Derived | Marcus BH, Dunsiger S, Pekmezi D, Benitez T, Larsen B, Meyer D. Physical activity outcomes from a randomized trial of a theory- and technology-enhanced intervention for Latinas: the Seamos Activas II study. J Behav Med. 2022 Feb;45(1):1-13. doi: 10.1007/s10865-021-00246-6. Epub 2021 Aug 11. |
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Participants attended an in-person orientation session where they received information about the study, had measures of height, weight, and self-reported PA taken to confirm eligibility. During a second visit, participants were measured (e.g, hip and waist circumference)) and given an ActiGraph GT3X+ accelerometer. After one week of continuous accelerometer wear, participants returned for their baseline visit where they completed questionnaires, had blood draws, then were randomized/
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| ID | Title | Description |
|---|---|---|
| FG000 | Original Tailored Intervention | This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals). Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety). |
| FG001 | Enhanced Tailored Intervention | We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial. Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Month Assessment |
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| 12 Month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Original Tailored Intervention | This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals). Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Accelerometer Measured Moderate to Vigorous PA (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. | Analysis was completed on the ITT sample | Posted | Median | Inter-Quartile Range | minutes/week | Baseline, 6 months and 12 months |
|
12 months
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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 | Original Tailored Intervention | This existing empirically supported Spanish-language PA intervention, which is based on Social Cognitive Theory and the Transtheoretical Model (TTM), emphasizes behavioral strategies for increasing PA levels (goal-setting, self-monitoring, problem-solving barriers, increasing social support, self-rewards for meeting PA goals). Original Tailored Intervention: The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toe Pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Participant reported feeling pain in her big toe. She stated that the pain is due to a bunion on her foot that she has had for the past 20 years. She sees her physician regularly and they have not advised her to discontinue physical activity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bess Marcus, Principle Investigator | Brown University | 401-863-6950 | 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 | Yes | No | No | Study Protocol | Dec 4, 2020 | Dec 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2015 | Mar 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Enhanced Tailored Intervention | Behavioral | Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring. |
|
| Baseline, 6 months and 12 months |
| Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL) | Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL), hemoglobin A1C (HbA1c), and blood pressure will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI). | Baseline, 6 months |
| Changes in Cholesterol | Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL) will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI). | Baseline, 6 months |
| Changes in Triglycerides | Blood samples will be collected at the baseline and 6-month clinic visits. | Baseline, 6 months |
| NOT COMPLETED |
|
| BG001 | Enhanced Tailored Intervention | We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial. Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring. |
| BG002 | Total | Total of all reporting groups |
| 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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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Self Reported Min/Week MVPA | Mean | Standard Deviation | minutes/week |
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| Objectively Measured Min/Week MVPA | Mean | Standard Deviation | minutes/week |
|
| OG001 | Enhanced Tailored Intervention | We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial. Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring. |
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|
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| Secondary | Change in 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. | Analysis was completed on the ITT sample | Posted | Median | Inter-Quartile Range | minutes/week | Baseline, 6 months and 12 months |
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| Secondary | Changes in Cardiovascular and Metabolic Biomarkers (e.g., HbA1c, and LDL) | Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL), hemoglobin A1C (HbA1c), and blood pressure will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI). | A subset of the full sample completed biomarker analysis at baseline and 6 months | Posted | Mean | Standard Deviation | percentage | Baseline, 6 months |
|
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|
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| Secondary | Changes in Cholesterol | Blood samples will be collected at the baseline and 6-month clinic visits. Specifically, low-density lipoprotein cholesterol (LDL) will be measured. These assays will be collected by personnel at the UCSD NIH-funded Clinical and Translational Research Institute (CTRI). | A subset of the full sample completed biomarker analysis at baseline and 6 months | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 months |
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| Secondary | Changes in Triglycerides | Blood samples will be collected at the baseline and 6-month clinic visits. | A subset of the full sample completed biomarker analysis at baseline and 6 months | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 months |
|
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|
| 0 |
| 97 |
| 0 |
| 97 |
| 5 |
| 97 |
| EG001 | Enhanced Tailored Intervention | We designed the Enhanced Tailored Intervention to build upon our previous research in order to outperform the original tailored intervention, in a cost effective, theoretically guided and data driven manner with potential for dissemination. Participants in the Enhanced Tailored Intervention will receive an interactive technology based intervention that: 1) addresses important SCT constructs for increasing PA that were not significantly changed in the original parent trial (enjoyment/outcome expectations and social support) and 2) provides greater accountability and interactivity for self-monitoring (through text messages), as requested by participants in the original parent trial. Enhanced Tailored Intervention: Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring. | 0 | 102 | 0 | 102 | 10 | 102 |
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| Infected Bladder | Renal and urinary disorders | Systematic Assessment | Participant stating that she just had surgery for an infected bladder. Her physician had instructed her to do no extraneous physical activity until further notice. Participant was put on medical hold until she could receive clearance. |
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| Hip Pain and Rash | General disorders | Systematic Assessment | Participant reporting that she had a rash on her leg and minor pain in her left hip but that she no longer feels any pain. |
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| Leg Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Heel and Back Pain | General disorders | Systematic Assessment | Participant reported pain in her heels which continued through the night and began to bother her back. She stated that she suffers from ingrown toenails and speculated that this condition may exacerbate the foot pain. |
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| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participant reported having lumbar spinal stenosis. The participant is confident that the pain/sciatica was not brought on by the exercise in the study and says the walking has actually been helpful. |
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| Foot Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | We received a completed adverse event from this participant stating pain in her foot. |
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| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Leg Injury | General disorders | Systematic Assessment | We received a completed adverse event form reporting that the participant hurt her leg when standing on top of a gallon jug and that she scratched and bruised her leg. |
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| Breast Biopsy | Reproductive system and breast disorders | Systematic Assessment | Participant had a minor biopsy to remove a small sample from her left breast. |
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| Stroke (unrelated to study) | Cardiac disorders | Systematic Assessment | Participant informed our staff member via phone that her daughter in the study had suffered a stroke last month while at school and thus she felt like it was necessary for her and her daughter withdraw from the study. |
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| 12 Months |
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| Baseline HDL |
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| 6 Month HDL |
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| Baseline LDL |
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| 6 Month LDL |
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