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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00131092
Other study ID # AG0033
Secondary ID R01AG016587Spons
Status Completed
Phase Phase 2
First received August 8, 2005
Last updated December 9, 2009
Start date June 1999
Est. completion date December 2003

Study information

Verified date December 2008
Source National Institute on Aging (NIA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare a telephone-administered physical activity counseling program delivered by a person or by a telephone-linked computer system and test their relative benefits in improving regular physical activity among adults ages 55 and older.


Description:

Two hundred and twenty five healthy, sedentary men and women ages 55 and older will be randomly assigned to one of three conditions: 12 months of physical activity counseling delivered by a human counselor, 12 months of physical activity counseling delivered by a telephone-linked computer system, or a 12-month attention-control condition (a health education class). Data on physical activity participation and related quality of life indicators (e.g., improved physical functioning, fitness, sleep) will be collected at baseline, 6 months, 12 month post-test and 18 month follow-up. The primary hypotheses are:

- participants in either physical activity counseling condition will show greater improvements in physical activity participation at 12 months compared to the attention-control condition;

- participants in the human counselor condition will show greater improvements in physical activity at 12 months relative to the computer condition; and

- participants in the computer condition will show better maintenance of physical activity between 12 and 18 months compared to participants in the human counselor condition.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date December 2003
Est. primary completion date December 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Men and women ages 55 and older

- Free of any medical condition that would limit participation in independent exercise

- Not currently engaged in a regular pattern of physical conditioning

- Free of clinical psychopathology

- Stable on current medications

- Planning to remain in the geographic area through the duration of the trial

- Able to read and speak English sufficiently to understand protocol materials

- Can use the telephone unaided

- Willing to accept random assignment to any study condition

Exclusion Criteria:

- Under the age of 55

- Currently under treatment for an acute, serious medical condition (e.g., cancer, heart disease, stroke)

- Physically active on a regular basis (i.e. performing more than 60 minutes per week of aerobic physical activity of at least a moderate intensity)

- Unstable and/or uncontrolled on medications for high blood pressure or depression

- Unable or unwilling to use a telephone unaided

- Unwilling to accept random assignment to study condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind


Related Conditions & MeSH terms


Intervention

Behavioral:
The Stanford Active Choices program

The TLC system


Locations

Country Name City State
United States Stanford Prevention Research Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Castro CM, King AC. Telephone-assisted counseling for physical activity. Exerc Sport Sci Rev. 2002 Apr;30(2):64-8. Review. — View Citation

Glanz K, Shigaki D, Farzanfar R, Pinto B, Kaplan B, Friedman RH. Participant reactions to a computerized telephone system for nutrition and exercise counseling. Patient Educ Couns. 2003 Feb;49(2):157-63. — View Citation

King AC, Friedman R, Marcus B, Castro C, Forsyth L, Napolitano M, Pinto B. Harnessing motivational forces in the promotion of physical activity: the Community Health Advice by Telephone (CHAT) project. Health Educ Res. 2002 Oct;17(5):627-36. — View Citation

Pinto BM, Friedman R, Marcus BH, Kelley H, Tennstedt S, Gillman MW. Effects of a computer-based, telephone-counseling system on physical activity. Am J Prev Med. 2002 Aug;23(2):113-20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in physical activity measured by the Stanford 7-Day Physical Activity Recall and the Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
Secondary Physical performance on a symptom-limited, graded exercise treadmill test
Secondary quality of life and psychological questionnaires measuring physical functioning, sleep, perceived stress, depressive symptoms
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