Clinical trial NCT04623489: ¡Vivir Mi Vida! Pilot Study
Official title: ¡Vivir Mi Vida!: A Pilot Study of a Lifestyle Intervention to Optimize Health Outcomes in Latino Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Antelope Valley Partners for Health
name: Wesley Health Centers - Antelope Valley
First posted: 2020-11-10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to 4 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
timeFrame: 4 months
measure: Change from baseline to 16 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
timeFrame: 16 months
measure: Change from 4 months to 16 months on the Measure Yourself Medical Outcome Profile (MYMOP2)
timeFrame: 16 months
Secondary outcomes:
measure: Change from baseline to 4 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
timeFrame: 4 months
measure: Change from baseline to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
timeFrame: 16 months
measure: Change from 4 months to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a
timeFrame: 16 months
measure: Change from baseline to 4 months on the Pittsburgh sleep quality index (PSQI)
timeFrame: 4 months
measure: Change from baseline to 16 months on the Pittsburgh sleep quality index (PSQI)
timeFrame: 16 months
measure: Change from 4 months to 16 months on the Pittsburgh sleep quality index (PSQI)
timeFrame: 16 months
measure: Change from baseline to 4 months on the Single item stress index
timeFrame: 4 months
measure: Change from baseline to 16 months on the Single item stress index
timeFrame: 16 months
measure: Change from 4 months to 16 months on the Single item stress index
timeFrame: 16 months
measure: Change from baseline to 4 months on the International Physical Activity Questionnaires (IPAQ)
timeFrame: 4 months
measure: Change from baseline to 16 months on the International Physical Activity Questionnaires (IPAQ)
timeFrame: 16 months
measure: Change from 4 months to 16 months on the International Physical Activity Questionnaires (IPAQ)
timeFrame: 16 months
measure: Change from baseline to 4 months on the Charlson comorbidity index
timeFrame: 4 months
measure: Change from baseline to 16 months on the Charlson comorbidity index
timeFrame: 16 months
measure: Change from 4 months to 16 months on the Charlson comorbidity index
timeFrame: 16 months
measure: Change from baseline to 4 months on Hemoglobin A1c
timeFrame: 4 months
measure: Change from baseline to 16 months on Hemoglobin A1c
timeFrame: 16 months
measure: Change from 4 months to 16 months on Hemoglobin A1c
timeFrame: 16 months
measure: Change from baseline to 4 months on Lipid profile (Triglycerides, HDL, LDL, Total)
timeFrame: 4 months
measure: Change from baseline to 4 months on systolic/diastolic blood pressure
timeFrame: 4 months
measure: Change from 4 months to 16 months on systolic/diastolic blood pressure
timeFrame: 16 months
measure: Change from baseline to 16 months on systolic/diastolic blood pressure
timeFrame: 16 months
measure: Change from baseline to 4 months on Coronary heart disease risk
timeFrame: 4 months
measure: Change from baseline to 16 months on Coronary heart disease risk
timeFrame: 16 months
measure: Change from 4 months to 16 months on Coronary heart disease risk
timeFrame: 16 months
measure: Change from baseline to 4 months on diabetes risk
timeFrame: 4 months
measure: Change from baseline to 16 months on diabetes risk
timeFrame: 16 months
measure: Change from 4 months to 16 months on diabetes risk
timeFrame: 4 months
measure: Change from baseline to 4 months on dietary intake based on Block 2005 food frequency questionnaire Spanish version
timeFrame: 4 months
measure: Change from 4 months to 16 months on patient activation measured using Patient Activation Measure 13
timeFrame: 16 months
measure: Pain measured using Brief Pain Inventory short form
timeFrame: 16 months
measure: Heart healthy behaviors measured using the My Habits questionnaire
timeFrame: 16 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.