Diabetes Mellitus, Type 2NCT00334113
Telerehabilitation Intervention to Promote Exercise for Diabetes
A study testing TLC-PED in people with Diabetes Mellitus, Type 2 and Obesity, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption. An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- TLC-PED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of type 2 diabetes mellitus
- Receive a medical clearance from physician
- Be sedentary
- Be interested in exercising
- Have a BMI > 25 kg/m2
- Have an HbA1c between 7 \& 10%
- Be on medication for diabetes
Who cannot join
- Significant peripheral neuropathy
- Active psychosis
- Psych admission or substance abuse in the last 6 months
- Severe brain dysfunction
- Abnormal ECG
- Orthopedic related limitations
- Unable to understand English
- No direct access to telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
About this study
The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption. An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or obese veterans with Type 2 diabetes.
Read the detailed description
Approximately two thirds of American adults are overweight (body mass index - BMI > 25), and nearly one third of American adults are obese (BMI > 30) with veterans exhibiting even higher rates of being overweight and obese than those in the general population. Obesity is a significant risk factor for a number of serious medical conditions, including diabetes, and is associated with high rates of morbidity, and mortality. Greater than 80% of individuals with diabetes are overweight or obese. Sixteen million Americans have been diagnosed with diabetes, and it has been speculated that this number will increase to 23 million by the year 2010. Furthermore, there is a substantially higher prevalence of diabetes in the veteran population as compared to the general population, with nearly 16 percent of veterans being affected. This alarming increase has been associated with the increasing prevalence of obesity and sedentary lifestyles. In a conference conducted by the National Institute of Diabetes and Digestive and Kidney Diseases in 1999, it was concluded that a major research initiative was needed to address the growing problem with physical inactivity and obesity because of the major impact these behaviors have on the development and treatment of diabetes.
The benefits associated with exercise in the diabetic population are extensive, and even though regular exercise is typically prescribed as a significant component of the diabetic treatment plan, compliance tends to be very poor. The overarching objective of this study is to adapt a low cost telephone intervention to be used to enhance exercise adoption in a population of overweight or obese veterans with type 2 diabetes. The primary aim of this study is to implement and evaluate the effectiveness of this telehealth intervention over a six month period. The secondary aim is to evaluate the impact this telehealth intervention has on weight and other diabetes relevant physical health parameters, quality of life and psychological distress. If the telehealth intervention is found to be efficacious, the tertiary aim will be to evaluate the cost effectiveness of the intervention. Over a 4-year period, 140 overweight or obese veterans with type 2 diabetes will be recruited from the VA Boston Healthcare System. All participants will be evaluated and provided with an exercise prescription for a home based walking program. Participants will be randomized to either the Exercise Prescription condition alone, or Exercise Prescription plus TLC-PED (Telephone Linked Care - Promoting Exercise for Diabetes), an automated telehealth intervention. TLC-PED will use interactive voice response and recognition telephone technology to provide individualized phone messages for participants with diabetes. It will be developed to incorporate theoretical principles that are known to enhance exercise adoption. Specifically, the intervention will use motivating principles based on the transtheoretical model of change. Those in the TLC-PED condition will receive weekly automated telephone calls for a six month period. It is hypothesized that overweight veterans with diabetes who receive the TLC-PED intervention (versus those who do not) during their six month participation in a home based walking program will be more likely to engage in regular physical activity and obtain improvements in self-reported physical activity, and maintain these changes over a twelve month period.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- TLC-PED
- Keywords
- Diabetes Mellitus, Exercise, Obesity, Telemedicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC-PEDBehavioural
Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will recieve an intervention that will be delivered over an automated telephone system (TLC-PED). These automated phone calls with voice response and voice recognition capabilities will occur weekly over a 6 month period. During these calls, participants' physical activity will be monitored, new physical activities goals will be set, information about physical activity and the associated health benefits will be provided, and barriers to physical activity will be explored. Receives: Behavioral: TLC-PED |
| Arm 2 | No intervention | This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Physical Activity Recall (PAR)
A self-report measure of minutes of physical activity over the previous 7 days.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJan 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Deanna L Mori, PhD, Principal investigator, VA Medical Center, Jamaica Plain Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334113
- Sponsor's protocol ID
- F4202-I
- Status last verified
- Dec 2014
- First submitted
- 2 Jun 2006
- Last updated
- 6 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Seligowski AV, Pless Kaiser AP, Niles BL, Mori DL, King LA, King DW. Sleep quality as a potential mediator between psychological distress and diabetes quality of life in veterans with type 2 diabetes. J Clin Psychol. 2013 Oct;69(10):1121-31. doi: 10.1002/jclp.21866. Epub 2012 May 25.
PubMed 22638910
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Intervention to Promote Exercise for Diabetes
- ClinicalTrials.gov ID
- NCT00334113
- Acronym / sponsor ID
- F4202-I
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- Diabetes Mellitus, Exercise, Obesity, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Posted 27 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption. An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or obese veterans with Type 2 diabetes.
Detailed description
Approximately two thirds of American adults are overweight (body mass index - BMI > 25), and nearly one third of American adults are obese (BMI > 30) with veterans exhibiting even higher rates of being overweight and obese than those in the general population. Obesity is a significant risk factor for a number of serious medical conditions, including diabetes, and is associated with high rates of morbidity, and mortality. Greater than 80% of individuals with diabetes are overweight or obese. Sixteen million Americans have been diagnosed with diabetes, and it has been speculated that this number will increase to 23 million by the year 2010. Furthermore, there is a substantially higher prevalence of diabetes in the veteran population as compared to the general population, with nearly 16 percent of veterans being affected. This alarming increase has been associated with the increasing prevalence of obesity and sedentary lifestyles. In a conference conducted by the National Institute of Diabetes and Digestive and Kidney Diseases in 1999, it was concluded that a major research initiative was needed to address the growing problem with physical inactivity and obesity because of the major impact these behaviors have on the development and treatment of diabetes.
The benefits associated with exercise in the diabetic population are extensive, and even though regular exercise is typically prescribed as a significant component of the diabetic treatment plan, compliance tends to be very poor. The overarching objective of this study is to adapt a low cost telephone intervention to be used to enhance exercise adoption in a population of overweight or obese veterans with type 2 diabetes. The primary aim of this study is to implement and evaluate the effectiveness of this telehealth intervention over a six month period. The secondary aim is to evaluate the impact this telehealth intervention has on weight and other diabetes relevant physical health parameters, quality of life and psychological distress. If the telehealth intervention is found to be efficacious, the tertiary aim will be to evaluate the cost effectiveness of the intervention. Over a 4-year period, 140 overweight or obese veterans with type 2 diabetes will be recruited from the VA Boston Healthcare System. All participants will be evaluated and provided with an exercise prescription for a home based walking program. Participants will be randomized to either the Exercise Prescription condition alone, or Exercise Prescription plus TLC-PED (Telephone Linked Care - Promoting Exercise for Diabetes), an automated telehealth intervention. TLC-PED will use interactive voice response and recognition telephone technology to provide individualized phone messages for participants with diabetes. It will be developed to incorporate theoretical principles that are known to enhance exercise adoption. Specifically, the intervention will use motivating principles based on the transtheoretical model of change. Those in the TLC-PED condition will receive weekly automated telephone calls for a six month period. It is hypothesized that overweight veterans with diabetes who receive the TLC-PED intervention (versus those who do not) during their six month participation in a home based walking program will be more likely to engage in regular physical activity and obtain improvements in self-reported physical activity, and maintain these changes over a twelve month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: TLC-PEDParticipants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will recieve an intervention that will be delivered over an automated telephone system (TLC-PED). These automated phone calls with voice response and voice recognition capabilities will occur weekly over a 6 month period. During these calls, participants' physical activity will be monitored, new physical activities goals will be set, information about physical activity and the associated health benefits will be provided, and barriers to physical activity will be explored. |
| Arm 2 | No intervention | –This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of type 2 diabetes mellitus
- Receive a medical clearance from physician
- Be sedentary
- Be interested in exercising
- Have a BMI > 25 kg/m2
Key exclusion criteria (8 listed)
- Significant peripheral neuropathy
- Active psychosis
- Psych admission or substance abuse in the last 6 months
- Severe brain dysfunction
- Abnormal ECG
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 |
|---|---|---|
| TLC-PEDTelephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program. | Behavioural | Arm 1 |
Primary outcome
7-Day Physical Activity Recall (PAR)
Time frame: six months
A self-report measure of minutes of physical activity over the previous 7 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22638910Seligowski AV, Pless Kaiser AP, Niles BL, Mori DL, King LA, King DW. Sleep quality as a potential mediator between psychological distress and diabetes quality of life in veterans with type 2 diabetes. J Clin Psychol. 2013 Oct;69(10):1121-31. doi: 10.1002/jclp.21866. Epub 2012 May 25.
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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.
Deanna L Mori, PhD principal investigator
VA Medical Center, Jamaica Plain Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLC-PED in people with Diabetes Mellitus, Type 2 and Obesity, run by US Department of Veterans Affairs 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 7 inclusion and 8 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 6 Jan 2015. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7-Day Physical Activity Recall (PAR) (time frame: six months). 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 NCT00334113, which also lists 1 linked publication.
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 6 Jan 2015.