Healthy LifestyleNCT04623489
¡Vivir Mi Vida! Pilot Study
A study testing ¡Vivir Mi Vida! Lifestyle Intervention in people with Healthy Lifestyle, run by University of Southern California at 1 site in United States.
Trial summary
Rationale: By the year 2050, the number of older adults in the US will more than double. Because older adults are more likely to develop chronic conditions such as cardiovascular disease and arthritis, society is facing a healthcare crisis if effective ways to prevent such diseases is not found. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- ¡Vivir Mi Vida! Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2015to 19 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged at least 50 years at the outset of the four-month intervention and will be no older than 65 years upon completion of the intervention
- Self-identify as Latino/Hispanic
- Are fluent in Spanish
- Live in Antelope Valley and do not plan on moving within six months from the beginning of the study
- Are enrolled as a patient in the Antelope Valley Community Clinic
- Have visited his/her primary care healthcare facility within the past year
Show all 9Show fewer
- Will be available by telephone for the duration of the intervention
- Are oriented to person, place, and time as tested by asking the person's name, date, age, and place of residence
- Self-report their ability to participate for the duration of the intervention
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089-9003
About this study
Official title: ¡Vivir Mi Vida!: A Pilot Study of a Lifestyle Intervention to Optimize Health Outcomes in Latino Patients
Rationale: By the year 2050, the number of older adults in the US will more than double. Because older adults are more likely to develop chronic conditions such as cardiovascular disease and arthritis, society is facing a healthcare crisis if effective ways to prevent such diseases is not found. This is especially urgent for Latinos because they are the nation's fastest growing ethnic group and they are in many cases at greater risk for chronic disease. Objectives: ln this proposed pilot project, the goal is to understand if a lifestyle intervention - iVivir Mi Vida! (iVMV!) - is feasible, acceptable, and shows preliminary promise in helping late middle-aged Latinos experience better health. The investigators will accomplish this goal by pilot testing the implementation of iVMV! in collaboration with community health service partners in Antelope Valley. Methods: ln this study, 40 patients, aged 50-65 years who are enrolled in Antelope Valley health centers will receive the iVMV! lifestyle-based health program. This program lasts four months and will be delivered by promotores (respected lay heath workers from the Latino community). Intervening promotores will be supervised by an occupational therapist and a senior promotora. Within the program, patients will participate in small group sessions at their local community healthcare facilities and will also receive numerous visits from the promotores in their homes. The program will involve weekly sessions in which the participants will be taught how to practice healthy lifestyle choices, such as exercising, eating healthy food, and reducing stress. Initially and at the end of the four-month program, the investigators will measure health outcomes such as self-rated quality of life, diet and exercise, cholesterol and glucose levels, blood pressure, and weight. The investigators will also ask participants, promotores, and other research staff about their overall experiences during the study so that the investigators can improve our program for the future. Mixed-methods procedures will be used to analyze qualitative data (e.g., interview transcripts) and quantitative data (e.g., pre-post intervention health outcomes and 12-month follow-up). Anticipated lmpact: The study will provide critical information about the feasibility and acceptability and preliminary data on the health impact of the iVMV! intervention on late middle-aged Latino adults who are at risk for disease. Information collected from this study will inform the design of a larger-scale implementation study.
- Conditions
- Healthy Lifestyle
- Being tested
- ¡Vivir Mi Vida! Lifestyle Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¡Vivir Mi Vida! Lifestyle InterventionBehavioural
Also called VMV
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 4 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
Comprised of an overall profile score and four symptom/well-being subscales. Individuals identified one to two currently bothersome symptoms. They rated each symptom's severity and how much it interfered with daily activities. They also rated their overall well-being.
MYMOP Profile Scores can be calculated as a mean of the ratings. These have values between 0 and 6; the higher the score, the worse the outcome. A decrease in scores is considered improvement.
Measured: 4 months
Change from baseline to 16 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
Comprised of an overall profile score and four symptom/well-being subscales. Individuals identified one to two currently bothersome symptoms. They rated each symptom's severity and how much it interfered with daily activities. They also rated their overall well-being.
MYMOP Profile Scores can be calculated as a mean of the ratings. These have values between 0 and 6; the higher the score, the worse the outcome. A decrease in scores is considered improvement.
Measured: 16 months
Change from 4 months to 16 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
Comprised of an overall profile score and four symptom/well-being subscales. Individuals identified one to two currently bothersome symptoms. They rated each symptom's severity and how much it interfered with daily activities. They also rated their overall well-being.
MYMOP Profile Scores can be calculated as a mean of the ratings. These have values between 0 and 6; the higher the score, the worse the outcome. A decrease in scores is considered improvement.
Measured: 16 months
Secondary outcomes (32)
Change from baseline to 4 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Satisfaction with performing usual social roles and activities
Measured: 4 months
Change from baseline to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Satisfaction with performing usual social roles and activities
Measured: 16 months
Change from 4 months to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Satisfaction with performing usual social roles and activities
Measured: 16 months
Change from baseline to 4 months on the Pittsburgh sleep quality index (PSQI)
Global sleep quality, sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction.
The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score of 0 indicates no difficulty, whereas a score of 3 indicates severe difficulty. The seven component scores are then added to yield one global score, with a range of 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas.
Measured: 4 months
Change from baseline to 16 months on the Pittsburgh sleep quality index (PSQI)
Global sleep quality, sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction.
The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score of 0 indicates no difficulty, whereas a score of 3 indicates severe difficulty. The seven component scores are then added to yield one global score, with a range of 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas.
Measured: 16 months
Change from 4 months to 16 months on the Pittsburgh sleep quality index (PSQI)
Global sleep quality, sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction.
The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score of 0 indicates no difficulty, whereas a score of 3 indicates severe difficulty. The seven component scores are then added to yield one global score, with a range of 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas.
Measured: 16 months
Change from baseline to 4 months on the Single item stress index
General level of stress 'these days' The response was recorded on a 5-point Likert scale varying from 1 "not at all" to 5 "very much." Higher score is worse stress.
Measured: 4 months
Change from baseline to 16 months on the Single item stress index
General level of stress 'these days' The response was recorded on a 5-point Likert scale varying from 1 "not at all" to 5 "very much." Higher score is worse stress.
Measured: 16 months
Change from 4 months to 16 months on the Single item stress index
General level of stress 'these days' The response was recorded on a 5-point Likert scale varying from 1 "not at all" to 5 "very much." Higher score is worse stress.
Measured: 16 months
Change from baseline to 4 months on the International Physical Activity Questionnaires (IPAQ)
Vigorous activity, moderate activity, walking, and time spent sitting.
There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Higher activity levels or more MET minutes per week equates to more physical activity.
Measured: 4 months
Change from baseline to 16 months on the International Physical Activity Questionnaires (IPAQ)
Vigorous activity, moderate activity, walking, and time spent sitting.
There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Higher activity levels or more MET minutes per week equates to more physical activity.
Measured: 16 months
Change from 4 months to 16 months on the International Physical Activity Questionnaires (IPAQ)
Vigorous activity, moderate activity, walking, and time spent sitting.
There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Higher activity levels or more MET minutes per week equates to more physical activity.
Measured: 16 months
Change from baseline to 4 months on the Charlson comorbidity index
Comorbidity status calculated from from electronic medical record diagnoses. 19 possible conditions as identified in Charlson 1987.
A weighted index of scores takes into account the presence vs absence of a disease and the seriousness of such disease. Conditions Scores range from 0-37 and depend on how many of the 19 possible conditions the person has and the seriousness of those conditions. Lower scores represent fewer or no comorbidities.
Measured: 4 months
Change from baseline to 16 months on the Charlson comorbidity index
Comorbidity status calculated from from electronic medical record diagnoses
Measured: 16 months
Change from 4 months to 16 months on the Charlson comorbidity index
Comorbidity status calculated from from electronic medical record diagnoses
Measured: 16 months
Change from baseline to 4 months on Hemoglobin A1c
Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA)
Measured: 4 months
Change from baseline to 16 months on Hemoglobin A1c
Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA) among participants with diabetes.
Measured: 16 months
Change from 4 months to 16 months on Hemoglobin A1c
Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA) among participants with diabetes.
Measured: 16 months
Change from baseline to 4 months on Lipid profile (Triglycerides, HDL, LDL, Total)
Non-fasting lipid profile measured by Cholestech meter (Alere, Inc.)
Measured: 4 months
Change from baseline to 4 months on systolic/diastolic blood pressure
Seated and resting blood pressure
Measured: 4 months
Change from 4 months to 16 months on systolic/diastolic blood pressure
Seated and resting blood pressure
Measured: 16 months
Change from baseline to 16 months on systolic/diastolic blood pressure
Seated and resting blood pressure
Measured: 16 months
Change from baseline to 4 months on Coronary heart disease risk
Calculated from Framingham risk score LDL points total. Coronary heart disease risk scores are the 10-year congenital heart disease risk. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Measured: 4 months
Change from baseline to 16 months on Coronary heart disease risk
Calculated from Framingham risk score LDL points total. Coronary heart disease risk scores are the 10-year congenital heart disease risk. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Measured: 16 months
Change from 4 months to 16 months on Coronary heart disease risk
Calculated from Framingham risk score LDL points total. Coronary heart disease risk scores are the 10-year congenital heart disease risk. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Measured: 16 months
Change from baseline to 4 months on diabetes risk
Calculated from European prospective investigation into cancer and nutrition (EPIC) diabetes risk score. Diabetes risk scores of 534-585 and 586-657 are associated with 3.0-4.9% and 5.0-9.9% incidence of diabetes within five years, respectively.
Measured: 4 months
Change from baseline to 16 months on diabetes risk
Calculated from European prospective investigation into cancer and nutrition (EPIC) diabetes risk score. Diabetes risk scores of 534-585 and 586-657 are associated with 3.0-4.9% and 5.0-9.9% incidence of diabetes within five years, respectively.
Measured: 16 months
Change from 4 months to 16 months on diabetes risk
Calculated from European prospective investigation into cancer and nutrition (EPIC) diabetes risk score. Diabetes risk scores of 534-585 and 586-657 are associated with 3.0-4.9% and 5.0-9.9% incidence of diabetes within five years, respectively.
Measured: 4 months
Change from baseline to 4 months on dietary intake based on Block 2005 food frequency questionnaire Spanish version
Usual and customary intake of a wide array of nutrients and food groups Dietary intake of sugar (g), sodium (mg), saturated fat (g), vegetables (servings), and fruit (servings) was reported. Generally, higher intake of sugar, sodium, and saturated fat and lower fruit/vegetable intake is associated with poor dietary intake patterns.
Measured: 4 months
Change from 4 months to 16 months on patient activation measured using Patient Activation Measure 13
One's knowledge of, skills in, and confidence in health self-management.
PAM 13 scores can theoretically range from 0-100. Higher PAM scores are related to more desirable outcome.
Measured: 16 months
Pain measured using Brief Pain Inventory short form
Pain is comprised of a severity and interference subscore. The severity subscale measures amount of pain a person has experienced at its "worst," "least," and "average" levels, as well as present pain. The interference subscale assesses how much a person's pain interferes with everyday life.
Measured: 16 months
Heart healthy behaviors measured using the My Habits questionnaire
Measure of heart healthy behaviors within 3 subscales: salt intake, fat and cholesterol consumption, and weight control behaviors. A 4-point Likert scale (1=never, 4=always) is used to answer "How often have you done the following over the past month?" Responses are summed and averaged for each subscale; higher scores represent healthier habits.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start28 Dec 2015
- Primary completion16 Aug 2017
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Antelope Valley Partners for Health, Wesley Health Centers - Antelope Valley
- Responsible party
- Principal investigator, Stacey Lynn Schepens Niemiec, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623489
- Sponsor's protocol ID
- HS-14-00725
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans were made to share data publicly as this was not a government-funded study.
Publications
Schepens Niemiec SL, Blanchard J, Vigen CLP, Martinez J, Guzman L, Concha A, Fluke M, Carlson M. Evaluation of inverted exclamation markVivir Mi Vida! to improve health and wellness of rural-dwelling, late middle-aged Latino adults: results of a feasibility and pilot study of a lifestyle intervention. Prim Health Care Res Dev. 2018 Sep;19(5):448-463. doi: 10.1017/S1463423617000901. Epub 2018 May 6.
PubMed 29729677Schepens Niemiec SL, Blanchard J, Vigen CLP, Martinez J, Guzman L, Fluke M, Carlson M. A Pilot Study of the inverted exclamation markVivir Mi Vida! Lifestyle Intervention for Rural-Dwelling, Late-Midlife Latinos: Study Design and Protocol. OTJR (Thorofare N J). 2019 Jan;39(1):5-13. doi: 10.1177/1539449218762728. Epub 2018 Mar 7.
PubMed 29514544Schepens Niemiec SL, Vigen CLP, Martinez J, Blanchard J, Carlson M. Long-Term Follow-Up of a Lifestyle Intervention for Late-Midlife, Rural-Dwelling Latinos in Primary Care. Am J Occup Ther. 2021 Mar-Apr;75(2):7502205020p1-7502205020p11. doi: 10.5014/ajot.2021.042861.
PubMed 33657344
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ¡Vivir Mi Vida!: A Pilot Study of a Lifestyle Intervention to Optimize Health Outcomes in Latino Patients
- ClinicalTrials.gov ID
- NCT04623489
- Acronym / sponsor ID
- HS-14-00725
- Conditions
- Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Antelope Valley Partners for Health, Wesley Health Centers - Antelope Valley
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: By the year 2050, the number of older adults in the US will more than double. Because older adults are more likely to develop chronic conditions such as cardiovascular disease and arthritis, society is facing a healthcare crisis if effective ways to prevent such diseases is not found. This is especially urgent for Latinos because they are the nation's fastest growing ethnic group and they are in many cases at greater risk for chronic disease. Objectives: ln this proposed pilot project, the goal is to understand if a lifestyle intervention - iVivir Mi Vida! (iVMV!) - is feasible, acceptable, and shows preliminary promise in helping late middle-aged Latinos experience better health. The investigators will accomplish this goal by pilot testing the implementation of iVMV! in collaboration with community health service partners in Antelope Valley. Methods: ln this study, 40 patients, aged 50-65 years who are enrolled in Antelope Valley health centers will receive the iVMV! lifestyle-based health program. This program lasts four months and will be delivered by promotores (respected lay heath workers from the Latino community). Intervening promotores will be supervised by an occupational therapist and a senior promotora. Within the program, patients will participate in small group sessions at their local community healthcare facilities and will also receive numerous visits from the promotores in their homes. The program will involve weekly sessions in which the participants will be taught how to practice healthy lifestyle choices, such as exercising, eating healthy food, and reducing stress. Initially and at the end of the four-month program, the investigators will measure health outcomes such as self-rated quality of life, diet and exercise, cholesterol and glucose levels, blood pressure, and weight. The investigators will also ask participants, promotores, and other research staff about their overall experiences during the study so that the investigators can improve our program for the future. Mixed-methods procedures will be used to analyze qualitative data (e.g., interview transcripts) and quantitative data (e.g., pre-post intervention health outcomes and 12-month follow-up). Anticipated lmpact: The study will provide critical information about the feasibility and acceptability and preliminary data on the health impact of the iVMV! intervention on late middle-aged Latino adults who are at risk for disease. Information collected from this study will inform the design of a larger-scale implementation study.
Study design
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults aged at least 50 years at the outset of the four-month intervention and will be no older than 65 years upon completion of the intervention
- Self-identify as Latino/Hispanic
- Are fluent in Spanish
- Live in Antelope Valley and do not plan on moving within six months from the beginning of the study
- Are enrolled as a patient in the Antelope Valley Community Clinic
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ¡Vivir Mi Vida! Lifestyle InterventionAlso: VMV | Behavioural | – |
Primary outcome
Change from baseline to 4 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
Time frame: 4 months
Comprised of an overall profile score and four symptom/well-being subscales. Individuals identified one to two currently bothersome symptoms. They rated each symptom's severity and how much it interfered with daily activities. They also rated their overall well-being. MYMOP Profile Scores can be calculated as a mean of the ratings. These have values between 0 and 6; the higher the score, the worse the outcome. A decrease in scores is considered improvement.
Change from baseline to 16 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
Time frame: 16 months
Comprised of an overall profile score and four symptom/well-being subscales. Individuals identified one to two currently bothersome symptoms. They rated each symptom's severity and how much it interfered with daily activities. They also rated their overall well-being. MYMOP Profile Scores can be calculated as a mean of the ratings. These have values between 0 and 6; the higher the score, the worse the outcome. A decrease in scores is considered improvement.
Change from 4 months to 16 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
Time frame: 16 months
Comprised of an overall profile score and four symptom/well-being subscales. Individuals identified one to two currently bothersome symptoms. They rated each symptom's severity and how much it interfered with daily activities. They also rated their overall well-being. MYMOP Profile Scores can be calculated as a mean of the ratings. These have values between 0 and 6; the higher the score, the worse the outcome. A decrease in scores is considered improvement.
32 secondary outcomes
Change from baseline to 4 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Time frame: 4 months
Change from baseline to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Time frame: 16 months
Change from 4 months to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Time frame: 16 months
Change from baseline to 4 months on the Pittsburgh sleep quality index (PSQI)
Time frame: 4 months
Change from baseline to 16 months on the Pittsburgh sleep quality index (PSQI)
Time frame: 16 months
Change from 4 months to 16 months on the Pittsburgh sleep quality index (PSQI)
Time frame: 16 months
Change from baseline to 4 months on the Single item stress index
Time frame: 4 months
Change from baseline to 16 months on the Single item stress index
Time frame: 16 months
Change from 4 months to 16 months on the Single item stress index
Time frame: 16 months
Change from baseline to 4 months on the International Physical Activity Questionnaires (IPAQ)
Time frame: 4 months
Change from baseline to 16 months on the International Physical Activity Questionnaires (IPAQ)
Time frame: 16 months
Change from 4 months to 16 months on the International Physical Activity Questionnaires (IPAQ)
Time frame: 16 months
Change from baseline to 4 months on the Charlson comorbidity index
Time frame: 4 months
Change from baseline to 16 months on the Charlson comorbidity index
Time frame: 16 months
Change from 4 months to 16 months on the Charlson comorbidity index
Time frame: 16 months
Change from baseline to 4 months on Hemoglobin A1c
Time frame: 4 months
Change from baseline to 16 months on Hemoglobin A1c
Time frame: 16 months
Change from 4 months to 16 months on Hemoglobin A1c
Time frame: 16 months
Change from baseline to 4 months on Lipid profile (Triglycerides, HDL, LDL, Total)
Time frame: 4 months
Change from baseline to 4 months on systolic/diastolic blood pressure
Time frame: 4 months
Change from 4 months to 16 months on systolic/diastolic blood pressure
Time frame: 16 months
Change from baseline to 16 months on systolic/diastolic blood pressure
Time frame: 16 months
Change from baseline to 4 months on Coronary heart disease risk
Time frame: 4 months
Change from baseline to 16 months on Coronary heart disease risk
Time frame: 16 months
Change from 4 months to 16 months on Coronary heart disease risk
Time frame: 16 months
Change from baseline to 4 months on diabetes risk
Time frame: 4 months
Change from baseline to 16 months on diabetes risk
Time frame: 16 months
Change from 4 months to 16 months on diabetes risk
Time frame: 4 months
Change from baseline to 4 months on dietary intake based on Block 2005 food frequency questionnaire Spanish version
Time frame: 4 months
Change from 4 months to 16 months on patient activation measured using Patient Activation Measure 13
Time frame: 16 months
Pain measured using Brief Pain Inventory short form
Time frame: 16 months
Heart healthy behaviors measured using the My Habits questionnaire
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 29729677Schepens Niemiec SL, Blanchard J, Vigen CLP, Martinez J, Guzman L, Concha A, Fluke M, Carlson M. Evaluation of inverted exclamation markVivir Mi Vida! to improve health and wellness of rural-dwelling, late middle-aged Latino adults: results of a feasibility and pilot study of a lifestyle intervention. Prim Health Care Res Dev. 2018 Sep;19(5):448-463. doi: 10.1017/S1463423617000901. Epub 2018 May 6.
- Background: PubMed 29514544Schepens Niemiec SL, Blanchard J, Vigen CLP, Martinez J, Guzman L, Fluke M, Carlson M. A Pilot Study of the inverted exclamation markVivir Mi Vida! Lifestyle Intervention for Rural-Dwelling, Late-Midlife Latinos: Study Design and Protocol. OTJR (Thorofare N J). 2019 Jan;39(1):5-13. doi: 10.1177/1539449218762728. Epub 2018 Mar 7.
- Background: PubMed 33657344Schepens Niemiec SL, Vigen CLP, Martinez J, Blanchard J, Carlson M. Long-Term Follow-Up of a Lifestyle Intervention for Late-Midlife, Rural-Dwelling Latinos in Primary Care. Am J Occup Ther. 2021 Mar-Apr;75(2):7502205020p1-7502205020p11. doi: 10.5014/ajot.2021.042861.
- Individual participant dataSharing planned: No. No plans were made to share data publicly as this was not a government-funded study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ¡Vivir Mi Vida! Lifestyle Intervention in people with Healthy Lifestyle, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 4 months on the Measure Yourself Medical Outcome Profile (MYMOP2) (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623489, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.