Type 2 Diabetes MellitusPhase 1NCT00542698
Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring
A Phase 1 study testing Effect of Physical Activity on Type II Diabetes Mellitus in people with Type 2 Diabetes Mellitus, run by National Institute of Nursing Research (NINR) at 2 sites in United States.
Trial summary
The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Effect of Physical Activity on Type II Diabetes Mellitus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Dec 2005
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus
- Three month blood sugar test (HbA1c) > 7.5%
- Not receiving insulin to manage diabetes
- Not engaged in a physical activity program more than 2 days per week
- Able to read and speak English
Who cannot join
- Not able to walk ¼ mile in 10 minutes
- Taking glucocoricoids
- Serious health problems, such as heart problems, found on examination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Berkshire Health System
Pittsfield, Massachusetts, 01201
Baystate Health System
Springfield, Massachusetts, 01199
About this study
Official title: Changing Activity Behavior With Glucose Sensor Feedback
The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health
Read the detailed description
Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Effect of Physical Activity on Type II Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Glucose Monitor graphs, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Physical Activity on Type II Diabetes MellitusBehavioural
Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group uses 90 minutes of standard diabetes education/ 7 days using the International Diabetes Center curriculum \& update phone call at 4 weeks. |
| Intervention | Experimental | Interventional group received standard diabetes education, CGMS monitor, and extra educational topics including CGMS counceling. Receives: Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
increased physical activity
Measured: 8 Weeks
Secondary outcomes (1)
BP, BMI, & HgA1c (a long term measure of blood glucose)
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startJul 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Nancy A Allen, Ph.D., Principal investigator, University of Massachusetts Worcester Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542698
- Sponsor's protocol ID
- 00004009
- Other IDs
- NIH: F31 NR008818-01A1
- Status last verified
- Oct 2007
- First submitted
- 10 Oct 2007
- Last updated
- 11 Oct 2007
- Results posted
- No
Publications
Abstract -OR 27: Effect of Counseling with Continuous Glucose Monitoring on Physical Activity Behaviors June 2006, Oral Presentation for American Diabetes Association 66th Scientific Session, Washington D.C
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Activity Behavior With Glucose Sensor Feedback
- ClinicalTrials.gov ID
- NCT00542698
- Acronym / sponsor ID
- 00004009
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Glucose Monitor graphs, Physical Activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Jul 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 11 Oct 2007 (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 this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health
Detailed description
Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group uses 90 minutes of standard diabetes education/ 7 days using the International Diabetes Center curriculum \& update phone call at 4 weeks. |
| Intervention | Experimental | Behavioral: Effect of Physical Activity on Type II Diabetes MellitusInterventional group received standard diabetes education, CGMS monitor, and extra educational topics including CGMS counceling. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Type 2 Diabetes Mellitus
- Three month blood sugar test (HbA1c) > 7.5%
- Not receiving insulin to manage diabetes
- Not engaged in a physical activity program more than 2 days per week
- Able to read and speak English
Key exclusion criteria (3 listed)
- Not able to walk ¼ mile in 10 minutes
- Taking glucocoricoids
- Serious health problems, such as heart problems, found on examination.
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 |
|---|---|---|
| Effect of Physical Activity on Type II Diabetes MellitusReviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals. | Behavioural | Intervention |
Primary outcome
increased physical activity
Time frame: 8 Weeks
1 secondary outcome
BP, BMI, & HgA1c (a long term measure of blood glucose)
Time frame: 8 Weeks
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 Oct 2007.
- Results publicationAbstract -OR 27: Effect of Counseling with Continuous Glucose Monitoring on Physical Activity Behaviors June 2006, Oral Presentation for American Diabetes Association 66th Scientific Session, Washington D.C
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
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.
Nancy A Allen, Ph.D. principal investigator
University of Massachusetts Worcester Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Effect of Physical Activity on Type II Diabetes Mellitus in people with Type 2 Diabetes Mellitus, run by National Institute of Nursing Research (NINR) at 2 sites 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 5 inclusion and 3 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 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
increased physical activity (time frame: 8 Weeks). 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 NCT00542698, 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 11 Oct 2007.