¡Vivir Mi Vida! Pilot Study

NCT04623489 | Completed

• 1 other identifier: HS-14-00725
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (32)

• Change from baseline to 4 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a

  4 months

• Change from baseline to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a

  16 months

• Change from 4 months to 16 months on the PROMIS Satisfaction with Participation in Social Roles - Short Form 7a

  16 months

• Change from baseline to 4 months on the Pittsburgh sleep quality index (PSQI)

  4 months

• Change from baseline to 16 months on the Pittsburgh sleep quality index (PSQI)

  16 months

Interventions

¡Vivir Mi Vida! Lifestyle Intervention BEHAVIORAL

Also known as: VMV

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Antelope Valley Partners for Health: collaborator
• Wesley Health Centers - Antelope Valley: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089-9003, United States

Location

Related Publications (3)

• 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.

  PMID: 29729677 BACKGROUND

• 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.

  PMID: 29514544 BACKGROUND

• 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.

  PMID: 33657344 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Research

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 10, 2020
• Study Start: December 28, 2015
• Primary Completion: August 16, 2017
• Study Completion: May 19, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)