¡Vivir Mi Vida! Pilot Study

Healthy Lifestyle Clinical Trial

Official title:

¡Vivir Mi Vida!: A Pilot Study of a Lifestyle Intervention to Optimize Health Outcomes in Latino Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623489
• Other study ID #: HS-14-00725
• Status: Completed
• Phase: N/A
• Start date: December 28, 2015
• Est. completion date: May 19, 2020

Study information

• Verified date: November 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 19, 2020
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

Inclusion Criteria:

1. 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

2. Self-identify as Latino/Hispanic

3. Are fluent in Spanish

4. Live in Antelope Valley and do not plan on moving within six months from the beginning of the study

5. Are enrolled as a patient in the Antelope Valley Community Clinic

6. Have visited his/her primary care healthcare facility within the past year

7. Will be available by telephone for the duration of the intervention

8. Are oriented to person, place, and time as tested by asking the person's name, date, age, and place of residence

9. Self-report their ability to participate for the duration of the intervention

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

Behavioral:
• ¡Vivir Mi Vida! Lifestyle Intervention

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Antelope Valley Partners for Health, Wesley Health Centers - Antelope Valley

Country where clinical trial is conducted

United States, 

References & Publications (2)

Schepens Niemiec SL, Blanchard J, Vigen CLP, Martínez J, Guzmán L, Concha A, Fluke M, Carlson M. Evaluation of ¡Vivir 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. — View Citation

Schepens Niemiec SL, Blanchard J, Vigen CLP, Martínez J, Guzmán L, Fluke M, Carlson M. A Pilot Study of the ¡Vivir 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Primary	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.	16 months
Primary	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.	16 months
Secondary	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	4 months
Secondary	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	16 months
Secondary	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	16 months
Secondary	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.	4 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	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.	4 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	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.	4 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	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.	4 months
Secondary	Change from baseline to 16 months on the Charlson comorbidity index	Comorbidity status calculated from from electronic medical record diagnoses	16 months
Secondary	Change from 4 months to 16 months on the Charlson comorbidity index	Comorbidity status calculated from from electronic medical record diagnoses	16 months
Secondary	Change from baseline to 4 months on Hemoglobin A1c	Non-fasting Hemoglobin A1c, measured by the Afinion meter (Alere, Inc., Waltham, MA, USA)	4 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	Change from baseline to 4 months on Lipid profile (Triglycerides, HDL, LDL, Total)	Non-fasting lipid profile measured by Cholestech meter (Alere, Inc.)	4 months
Secondary	Change from baseline to 4 months on systolic/diastolic blood pressure	Seated and resting blood pressure	4 months
Secondary	Change from 4 months to 16 months on systolic/diastolic blood pressure	Seated and resting blood pressure	16 months
Secondary	Change from baseline to 16 months on systolic/diastolic blood pressure	Seated and resting blood pressure	16 months
Secondary	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.	4 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	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.	4 months
Secondary	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.	16 months
Secondary	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.	4 months
Secondary	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.	4 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	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.	16 months