- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04623489
¡Vivir Mi Vida! Pilot Study
¡Vivir Mi Vida!: A Pilot Study of a Lifestyle Intervention to Optimize Health Outcomes in Latino Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089-9003
- University of Southern California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
4 months
|
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. |
16 months
|
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. |
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to 4 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Time Frame: 4 months
|
Satisfaction with performing usual social roles and activities
|
4 months
|
Change from baseline to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
Time Frame: 16 months
|
Satisfaction with performing usual social roles and activities
|
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
|
Satisfaction with performing usual social roles and activities
|
16 months
|
Change from baseline to 4 months on the Pittsburgh sleep quality index (PSQI)
Time Frame: 4 months
|
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. |
4 months
|
Change from baseline to 16 months on the Pittsburgh sleep quality index (PSQI)
Time Frame: 16 months
|
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. |
16 months
|
Change from 4 months to 16 months on the Pittsburgh sleep quality index (PSQI)
Time Frame: 16 months
|
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. |
16 months
|
Change from baseline to 4 months on the Single item stress index
Time Frame: 4 months
|
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.
|
4 months
|
Change from baseline to 16 months on the Single item stress index
Time Frame: 16 months
|
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.
|
16 months
|
Change from 4 months to 16 months on the Single item stress index
Time Frame: 16 months
|
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.
|
16 months
|
Change from baseline to 4 months on the International Physical Activity Questionnaires (IPAQ)
Time Frame: 4 months
|
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. |
4 months
|
Change from baseline to 16 months on the International Physical Activity Questionnaires (IPAQ)
Time Frame: 16 months
|
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. |
16 months
|
Change from 4 months to 16 months on the International Physical Activity Questionnaires (IPAQ)
Time Frame: 16 months
|
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. |
16 months
|
Change from baseline to 4 months on the Charlson comorbidity index
Time Frame: 4 months
|
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. |
4 months
|
Change from baseline to 16 months on the Charlson comorbidity index
Time Frame: 16 months
|
Comorbidity status calculated from from electronic medical record diagnoses
|
16 months
|
Change from 4 months to 16 months on the Charlson comorbidity index
Time Frame: 16 months
|
Comorbidity status calculated from from electronic medical record diagnoses
|
16 months
|
Change from baseline to 4 months on Hemoglobin A1c
Time Frame: 4 months
|
Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA)
|
4 months
|
Change from baseline to 16 months on Hemoglobin A1c
Time Frame: 16 months
|
Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA) among participants with diabetes.
|
16 months
|
Change from 4 months to 16 months on Hemoglobin A1c
Time Frame: 16 months
|
Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA) among participants with diabetes.
|
16 months
|
Change from baseline to 4 months on Lipid profile (Triglycerides, HDL, LDL, Total)
Time Frame: 4 months
|
Non-fasting lipid profile measured by Cholestech meter (Alere, Inc.)
|
4 months
|
Change from baseline to 4 months on systolic/diastolic blood pressure
Time Frame: 4 months
|
Seated and resting blood pressure
|
4 months
|
Change from 4 months to 16 months on systolic/diastolic blood pressure
Time Frame: 16 months
|
Seated and resting blood pressure
|
16 months
|
Change from baseline to 16 months on systolic/diastolic blood pressure
Time Frame: 16 months
|
Seated and resting blood pressure
|
16 months
|
Change from baseline to 4 months on Coronary heart disease risk
Time Frame: 4 months
|
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.
|
4 months
|
Change from baseline to 16 months on Coronary heart disease risk
Time Frame: 16 months
|
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.
|
16 months
|
Change from 4 months to 16 months on Coronary heart disease risk
Time Frame: 16 months
|
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.
|
16 months
|
Change from baseline to 4 months on diabetes risk
Time Frame: 4 months
|
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.
|
4 months
|
Change from baseline to 16 months on diabetes risk
Time Frame: 16 months
|
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.
|
16 months
|
Change from 4 months to 16 months on diabetes risk
Time Frame: 4 months
|
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.
|
4 months
|
Change from baseline to 4 months on dietary intake based on Block 2005 food frequency questionnaire Spanish version
Time Frame: 4 months
|
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.
|
4 months
|
Change from 4 months to 16 months on patient activation measured using Patient Activation Measure 13
Time Frame: 16 months
|
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. |
16 months
|
Pain measured using Brief Pain Inventory short form
Time Frame: 16 months
|
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.
|
16 months
|
Heart healthy behaviors measured using the My Habits questionnaire
Time Frame: 16 months
|
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.
|
16 months
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Schepens 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.
- Schepens 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS-14-00725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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