Clinical trial NCT00786344: USC Well Elderly Study 2
Official title: Health Mediating Effects of the Well Elderly Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Health Promotion: Wellness Programs
Occupational Therapy
Quality of Life
Health
Biomarkers
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-11-06
Enrollment: 460
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to learn how activity promotes health and well being among older adults. There are two main study goals: (1) to extend the previous results obtained for the Well Elderly Study 1; and (2) to determine what factors make the program successful.

Detailed description: Previous theory and research implicates participation in meaningful activity as an important factor in enhancing older adults' health-related quality of life. Consistent with this emphasis, a previous R01 grant completed by our study group demonstrated that an activity-based intervention (the Well Elderly Intervention) reduced declines in a wide variety of health-related parameters among low income, ethnically diverse elders. In the current four-year project, we attempted to replicate our previous result while simultaneously examining the mediating mechanisms responsible for its positive effects. The outcomes of this study will provide important new information about the process events by which activity-based lifestyle interventions influence key aging outcomes.

In the study, 460 ethnically diverse elders were recruited from 21 sites in the greater Los Angeles area, and participated in a randomized experiment containing a semi-crossover design component. The sites included 9 senior citizen centers (Culver City Senior Center, Estelle Van Meter Multipurpose Center, Hawthorne Senior Center, Hollywood Senior Multipurpose Center, Joslyn Adult Center - Burbank, Lennox Senior Center, Long Beach Senior Center, St. Barnabas Senior Center, and Slauson Recreation Center), as well as 12 senior residences (Casa TELACU, Covenant Manor, Eucalyptus Park, George McDonald Court, Motion Picture and Television Fund, Pilgrim Towers East, Regent Plaza, TELACU Del Rio, TELACU Manor, TELACU Senior Housing, TELACU Terrace, and Ward Villas).

Within either the first or second six-month phase of their study involvement, each subject received a lifestyle-based intervention designed to improve a variety of aging outcomes. At 4-5 points in time over an 18-24 month interval, elders completed assessments of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the efficacy of the intervention and document the process mechanisms responsible for its effects.

The study has three long-term objectives. First, it will lead to more effective health care services for our nation's rapidly growing elderly population, thereby fulfilling a major policy priority for older adults, namely, preventing declines in their health and independence. Second, it will generate new information regarding how activity influences aging outcomes. Although previous research has shown that activity patterns consistently relate to important aging outcomes, little is known about how the psychological and biological changes that stem from activities combine to promote successful aging. This study will reduce this knowledge gap. Third, due to the significant ethnic diversity at the study sites, the project will produce results that generalize to minority elders. This outcome is important due to the increasing ethnic diversity of our nation's aging population.

Eligibility criteria: Inclusion Criteria:

* Fluent speaker of English or Spanish
* Living in the community

Exclusion Criteria:

* Hospitalized
* Living in nursing home
* Mental confusion/dementia
* Participation in the first Well Elderly Study

Primary outcomes:
measure: Perceived Physical Health
timeFrame: within 1 month of completion of intervention
measure: Psychosocial Well-Being
timeFrame: within 1 month of completion of intervention
measure: Cognitive Functioning
timeFrame: within 1 month of completion of intervention
Secondary outcomes:
measure: Healthy Activity
timeFrame: within 1 month of completion of intervention
measure: Active Coping
timeFrame: within 1 month of completion of intervention
measure: Perceived Control
timeFrame: within 1 month of completion of intervention
measure: Social Support
timeFrame: within 1 month of completion of intervention
measure: Positive Reinterpretation-Based Coping
timeFrame: within 1 month of completion of intervention
measure: Stress-Related Biomarkers
timeFrame: within 1 month of completion of intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Florence A Clark, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leland NE, Fogelberg D, Sleight A, Mallinson T, Vigen C, Blanchard J, Carlson M, Clark F. Napping and Nighttime Sleep: Findings From an Occupation-Based Intervention. Am J Occup Ther. 2016 Jul-Aug;70(4):7004270010p1-7. doi: 10.5014/ajot.2016.017657.
citation: Clark F, Jackson J, Carlson M, Chou CP, Cherry BJ, Jordan-Marsh M, Knight BG, Mandel D, Blanchard J, Granger DA, Wilcox RR, Lai MY, White B, Hay J, Lam C, Marterella A, Azen SP. Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial. J Epidemiol Community Health. 2012 Sep;66(9):782-90. doi: 10.1136/jech.2009.099754. Epub 2011 Jun 2.