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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT00334113
Study groupRoleWhat they receive
Arm 1ExperimentalParticipants 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 2No interventionThis 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.

  1. 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.

  1. First posted6 Jun 2006 (estimated)
  2. Study startJan 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

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)
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
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

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.

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