Health BehaviorPhase 2NCT00131092
The CHAT (Community Health Advice by Telephone) Study
A Phase 2 study testing The Stanford Active Choices program and The TLC system in people with Health Behavior and Healthy, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Healthy
- What is being tested?
- The Stanford Active Choices program and The TLC system
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Stanford, California, 94305-5705
About this study
Official title: Exercise Advice by Human or Computer: Testing 2 Theories
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.
Read the detailed 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.
- Conditions
- Health Behavior, Healthy
- Being tested
- The Stanford Active Choices program, The TLC system
- Keywords
- exercise, aging, physical activity
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Stanford Active Choices programBehavioural
The TLC systemBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
Physical performance on a symptom-limited, graded exercise treadmill test
quality of life and psychological questionnaires measuring physical functioning, sleep, perceived stress, depressive symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startJun 1999
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 225 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Abby C. King, PhD, Principal investigator, Stanford Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131092
- Sponsor's protocol ID
- AG0033
- Other IDs
- R01AG016587, Sponsored Proj. Office #20047
- Status last verified
- Dec 2008
- First submitted
- 8 Aug 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
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. doi: 10.1093/her/17.5.627.
PubMed 12408207Castro CM, King AC. Telephone-assisted counseling for physical activity. Exerc Sport Sci Rev. 2002 Apr;30(2):64-8. doi: 10.1097/00003677-200204000-00004.
PubMed 11991539Pinto 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. doi: 10.1016/s0749-3797(02)00441-5.
PubMed 12121799Glanz 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. doi: 10.1016/s0738-3991(02)00076-9.
PubMed 12566210
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Advice by Human or Computer: Testing 2 Theories
- ClinicalTrials.gov ID
- NCT00131092
- Acronym / sponsor ID
- AG0033
- Conditions
- Health Behavior, Healthy
- Keywords
- exercise, aging, physical activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Jun 1999
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Stanford Active Choices program | Behavioural | – |
| The TLC system | Behavioural | – |
Primary outcome
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
2 secondary outcomes
Physical performance on a symptom-limited, graded exercise treadmill test
quality of life and psychological questionnaires measuring physical functioning, sleep, perceived stress, depressive symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 12408207King 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. doi: 10.1093/her/17.5.627.
- Background: PubMed 11991539Castro CM, King AC. Telephone-assisted counseling for physical activity. Exerc Sport Sci Rev. 2002 Apr;30(2):64-8. doi: 10.1097/00003677-200204000-00004.
- Background: PubMed 12121799Pinto 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. doi: 10.1016/s0749-3797(02)00441-5.
- Background: PubMed 12566210Glanz 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. doi: 10.1016/s0738-3991(02)00076-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby C. King, PhD principal investigator
Stanford Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The Stanford Active Choices program and The TLC system in people with Health Behavior and Healthy, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131092, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.