Confronting challenges in intervention research with ethnically diverse older adults: the USC Well Elderly II Trial.
BACKGROUND
Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines.


OBJECTIVE
The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial.


METHODS
In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects.


RESULTS
The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base.


CONCLUSIONS
Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery.


CONCLUSIONS
The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.
Jackson
Jeanne
J
Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles 90089-9003, USA. jmjackso@usc.edu.
Mandel
Deborah
D
Blanchard
Jeanine
J
Carlson
Mike
M
Cherry
Barbara
B
Azen
Stanley
S
Chou
Chih-Ping
CP
Jordan-Marsh
Maryalice
M
Forman
Todd
T
White
Brett
B
Granger
Douglas
D
Knight
Bob
B
Clark
Florence
F
D000223:Adaptation, Psychological; D000368:Aged; D002140:California; D005006:Ethnicity; D006293:Health Promotion; D006304:Health Status; D006801:Humans; D008019:Life Style; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design