NCT00786344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
Last Updated

November 6, 2008

Status Verified

October 1, 2008

Enrollment Period

3.9 years

First QC Date

November 4, 2008

Last Update Submit

November 4, 2008

Conditions

Aged

Keywords

Health Promotion: Wellness ProgramsOccupational TherapyQuality of LifeHealthBiomarkers

Outcome Measures

Primary Outcomes (3)

  • Perceived Physical Health

    within 1 month of completion of intervention

  • Psychosocial Well-Being

    within 1 month of completion of intervention

  • Cognitive Functioning

    within 1 month of completion of intervention

Secondary Outcomes (6)

  • Healthy Activity

    within 1 month of completion of intervention

  • Active Coping

    within 1 month of completion of intervention

  • Perceived Control

    within 1 month of completion of intervention

  • Social Support

    within 1 month of completion of intervention

  • Positive Reinterpretation-Based Coping

    within 1 month of completion of intervention

  • +1 more secondary outcomes

Study Arms (2)

Lifestyle Redesign

EXPERIMENTAL
Behavioral: Lifestyle Redesign

No Treatment Control

NO INTERVENTION

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.

Interventions

Lifestyle RedesignBEHAVIORAL

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.

Also known as: Well Elderly Intervention
Lifestyle Redesign

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089-9003, United States

Location

Related Publications (2)

  • 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.

    PMID: 27294991DERIVED

  • 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.

    PMID: 21636614DERIVED

Study Officials

  • Florence A Clark, PhD, OTR/L

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 6, 2008

Study Start

November 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 6, 2008

Record last verified: 2008-10

Locations

US(1)