DietNCT00314197
Improving Health Behaviors Through Telephone Linked Care
A study testing Telephone Linked Care - Behavior Change Counseling System and Telephone-linked behavioral counseling in people with Diet and Physical Activity, run by American Academy of Family Physicians at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet, Physical Activity, Smoking
- What is being tested?
- Telephone Linked Care - Behavior Change Counseling System and Telephone-linked behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jun 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Capable of giving informed consent
- Reliable access to a phone
- Able to read English
Who cannot join
- Less than 18 years of age
- Not capable of giving informed consent
- No reliable access to a phone
- Unable to read English (including blindness)
- Too ill to participate
- Not willing to allow the Telephone Linked Care - Behavior Change system to provide health information reports based on responses to physician
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Family Physicians National Research Network
Leawood, Kansas, 66211-2672
About this study
Official title: Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
The investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to:
- successfully integrate an automated telephone behavior change intervention into primary care practices;
- demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the TLC-BC system compared to individuals who receive written health education informational packets; and
- evaluate the direct costs associated with the use and operation of the TLC-BC system.
Read more
Project aims and hypotheses follow:
Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by the patient and clinician/staff surveys at the end of data collection.
Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the TLC-BC system compared to individuals who receive written informational packets.
Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system within the primary care setting.
Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully implemented by patients and practices.
Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group.
Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
Read the detailed description
See above
- Conditions
- Diet, Physical Activity, Smoking, Alcohol Abuse
- Being tested
- Telephone Linked Care - Behavior Change Counseling System, Telephone-linked behavioral counseling
- Keywords
- automated counseling system, telephone-based intervention, behavior change
- Medical subject headings
- Motor Activity, Smoking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Linked Care - Behavior Change Counseling SystemBehavioural
Telephone-linked behavioral counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group
Measured: 6 months
At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
Measured: baseline, 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startApr 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DietStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Family Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Wilson D Pace, MD, FAAFP, Principal investigator, American Academy of Family Physicians National Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314197
- Sponsor's protocol ID
- 06-005
- Status last verified
- Sep 2007
- First submitted
- 11 Apr 2006
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
- ClinicalTrials.gov ID
- NCT00314197
- Acronym / sponsor ID
- 06-005
- Conditions
- Diet, Physical Activity, Smoking, Alcohol Abuse
- Keywords
- automated counseling system, telephone-based intervention, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- American Academy of Family PhysiciansUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Apr 2006 (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 investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to:
- successfully integrate an automated telephone behavior change intervention into primary care practices;
- demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the TLC-BC system compared to individuals who receive written health education informational packets; and
- evaluate the direct costs associated with the use and operation of the TLC-BC system.
Project aims and hypotheses follow:
Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by the patient and clinician/staff surveys at the end of data collection.
Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the TLC-BC system compared to individuals who receive written informational packets.
Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system within the primary care setting.
Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully implemented by patients and practices.
Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group.
Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
Detailed description
See above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Capable of giving informed consent
- Reliable access to a phone
- Able to read English
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Not capable of giving informed consent
- No reliable access to a phone
- Unable to read English (including blindness)
- Too ill to participate
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 |
|---|---|---|
| Telephone Linked Care - Behavior Change Counseling System | Behavioural | – |
| Telephone-linked behavioral counseling | Behavioural | – |
Primary outcome
At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group
Time frame: 6 months
At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
Time frame: baseline, 3, 6, and 9 months
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 26 Sep 2007.
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Healthy Volunteers
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.
Wilson D Pace, MD, FAAFP principal investigator
American Academy of Family Physicians National Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Linked Care - Behavior Change Counseling System and Telephone-linked behavioral counseling in people with Diet and Physical Activity, run by American Academy of Family Physicians 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 4 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 26 Sep 2007. 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.
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?
At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2007.