USC Well Elderly Study 2

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT00786344
Collaborator
National Institute on Aging (NIA) (NIH)
460
1
2
47
9.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle Redesign
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Official Title:
Health Mediating Effects of the Well Elderly Program
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lifestyle Redesign

Behavioral: Lifestyle Redesign
For a six-month period, each elder participated in weekly 2-hour sessions involving groups of size 8-10, and also received up to 10 hours of individualized treatment over this time period. Modular treatment units included the following content areas: (1) Introduction to the Power of Activity; (2) Aging, Health, and Activity; (3) Transportation; (4) Safety; (5) Social Relationships; (6) Cultural Awareness; (7) Finances; and (8) Integrative Summary: Lifestyle Redesign Notebook. The methods of program delivery consisted of didactic presentation, peer exchange, direct experience, and personal exploration. Treatment materials were translated into Spanish and culturally adapted for approximately 15% of the subjects.
Other Names:
  • Well Elderly Intervention
  • No Intervention: No Treatment Control

    The no treatment control arm did not receive the intervention during the first six-month period. However the intervention, which has been proven to be beneficial, was administered to the control arm immediately following the 6 month assessment.

    Outcome Measures

    Primary Outcome Measures

    1. Perceived Physical Health [within 1 month of completion of intervention]

    2. Psychosocial Well-Being [within 1 month of completion of intervention]

    3. Cognitive Functioning [within 1 month of completion of intervention]

    Secondary Outcome Measures

    1. Healthy Activity [within 1 month of completion of intervention]

    2. Active Coping [within 1 month of completion of intervention]

    3. Perceived Control [within 1 month of completion of intervention]

    4. Social Support [within 1 month of completion of intervention]

    5. Positive Reinterpretation-Based Coping [within 1 month of completion of intervention]

    6. Stress-Related Biomarkers [within 1 month of completion of intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Los Angeles California United States 90089-9003

    Sponsors and Collaborators

    • University of Southern California
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Florence A Clark, PhD, OTR/L, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00786344
    Other Study ID Numbers:
    • 5R01AG021108-04
    First Posted:
    Nov 6, 2008
    Last Update Posted:
    Nov 6, 2008
    Last Verified:
    Oct 1, 2008

    Study Results

    No Results Posted as of Nov 6, 2008