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 Type
INTERVENTIONAL
Masking
NONE
University of Southern California
Los Angeles, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 16 months
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
Change from baseline to 16 months on the Charlson comorbidity index
Comorbidity status calculated from from electronic medical record diagnoses
Time frame: 16 months
Change from 4 months to 16 months on the Charlson comorbidity index
Comorbidity status calculated from from electronic medical record diagnoses
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.)
Time frame: 4 months
Change from baseline to 4 months on systolic/diastolic blood pressure
Seated and resting blood pressure
Time frame: 4 months
Change from 4 months to 16 months on systolic/diastolic blood pressure
Seated and resting blood pressure
Time frame: 16 months
Change from baseline to 16 months on systolic/diastolic blood pressure
Seated and resting blood pressure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 months
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