Type 2 DiabetesKPTLCPNCT01484353
Intensive Lifestyle Intervention for Type 2 Diabetics: The KP TLC Pilot
A study testing Coronary Health Improvement Project Program in people with Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to determine if a healthy lifestyle intervention can significantly improve blood sugar control in type 2 diabetics over a course of 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Coronary Health Improvement Project Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- English-speaking patients > 18 years of age, with at least 6 months of membership, who have type 2 diabetes.
- Patients must have a recent HbA1C lab value > 8.0, and have had at least 2 previous HbA1C measures during the previous 6-12 months.
- Patients with HbA1C values that are consistently > 8.0 over the previous 6-12 months will be invited to participate.
Who cannot join
- current excessive alcohol use (drinking > 14 alcohol beverages per week for men or > 7 per week for women or > 4 per day for men or > 2 per day for women on 2 or more occasions each month)
- current use of illegal or street drugs,
- severely decreased functional capacity (shortness of breath or chest pain at rest or with minimal activity), and/or
- suicidal thoughts or depression, will
- Patients with severely limited physical ability
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
About this study
Official title: Intensive Lifestyle Intervention for Type 2 Diabetics: The Kaiser Permanente TLC Pilot
The purpose of this study is to determine if a healthy lifestyle intervention can significantly improve blood sugar control in type 2 diabetics over a course of 3 months.
Read the detailed description
Peer reviewed research studies have proven the benefits of lifestyle interventions including the reversal of coronary artery disease and of diabetes. Experts agree that such a lifestyle must include a diet rich in whole, grown foods while low in saturated fat and cholesterol; regular physical activity; and healthy ways to cope with stress.
There are several challenges with implementing such lifestyle interventions such as educating the general public and health care providers to the components of this lifestyle and in getting people to adopt these healthy lifestyle changes.
While retreat-style, intensive lifestyle programs have shown that these obstacles can be overcome, they require monetary and time investments generally not feasible for the general public.
A community-based, lifestyle program such as 'The Coronary Health Improvement Project' program offers similar potential benefits at a more reasonable cost. It does so through an intensive education (32 hours total) taught over 4 weeks, followed by an 8-week consolidation period which include live or DVD based group sessions, discussions led by a program facilitator, and medical monitoring.
Kaiser Permanente, the leading Health maintenance organization in the nation, places special focus and significant resources into preventive medicine and health promotion, providing services to thousands of plan members but none with the level of intensity of 'The Coronary Health Improvement Project'.
This study aims to determine if 'The Coronary Health Improvement Project' program can significantly improve blood sugar control in kaiser plan members with uncontrolled diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Coronary Health Improvement Project Program
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Health Improvement Project ProgramBehavioural
The Coronary Health Improvement Project' (CHIP; an intensive, community-based, lifestyle change program including a low saturated fat diet rich in whole, grown foods) has been shown to improve the health of diabetics through an intensive education taught over a 12 week period, but has not been studied in terms of its effect on HBAIC. Kaiser Permanente places significant resources into preventive medicine but does not have programs with the level of intensity of CHIP. This study aims to determine if Kaiser members with uncontrolled type 2 diabetes can achieve a significant improvement in their HBAIC after 12 weeks of participation in the CHIP program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This is the only arm in the study. They will be compared before and after Receives: Behavioral: Coronary Health Improvement Project Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBAIC before and after intervention
Baseline HbA1C will be measured within two weeks of the start of the intervention. Follow-up HbA1C will be measured at 12 weeks after the start of the intervention, as HbA1C is a measure of glycemic control over approximately 12 weeks.
Measured: 3 months
Secondary outcomes (5)
Average weekly blood sugar
Baseline blood glucose readings will be checked one week prior to the start of the intervention, as well as weekly during the study for medication adjustment by a specialized Kaiser Permanente physician (weekly monitoring of blood glucose levels based on checks performed 3 times/day, for at least 3 consecutive days during the week, and then averaged). Follow-up blood glucose levels will be self-measured by patient glucometer, 3 times/ day, for at least 3 consecutive days. The average of these readings will be computed, as the "average weekly blood sugar"
Measured: 3 months
Lipids
Baseline fasting lipid panel will be ascertained within two weeks prior to the start of the intervention. Follow-up fasting lipids will be measured at 4 weeks and at 12 weeks after the start of the intervention.
Measured: 3 months
Weight
Baseline height, weight, waist circumference, hip circumference, and systolic and diastolic blood pressure will be measured within one week of the start of the intervention. Follow-up measures will be ascertained at 4, 8, and 12 weeks after the start of the intervention.
Measured: 3 months
waist circumference
Baseline height, weight, waist circumference, hip circumference, and systolic and diastolic blood pressure will be measured within one week of the start of the intervention. Follow-up measures will be ascertained at 4, 8, and 12 weeks after the start of the intervention.
Measured: 3 months
Blood pressure
Baseline height, weight, waist circumference, hip circumference, and systolic and diastolic blood pressure will be measured within one week of the start of the intervention. Follow-up measures will be ascertained at 4, 8, and 12 weeks after the start of the intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
Why it stopped: This study was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario A Robinson, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484353
- Sponsor's protocol ID
- KPTLC Pilot
- Acronym
- KPTLCP
- Status last verified
- Mar 2015
- First submitted
- 30 Nov 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Lifestyle Intervention for Type 2 Diabetics: The Kaiser Permanente TLC Pilot
- ClinicalTrials.gov ID
- NCT01484353
- Acronym / sponsor ID
- KPTLCP / KPTLC Pilot
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- First posted
- 2 Dec 2011 (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 is to determine if a healthy lifestyle intervention can significantly improve blood sugar control in type 2 diabetics over a course of 3 months.
Detailed description
Peer reviewed research studies have proven the benefits of lifestyle interventions including the reversal of coronary artery disease and of diabetes. Experts agree that such a lifestyle must include a diet rich in whole, grown foods while low in saturated fat and cholesterol; regular physical activity; and healthy ways to cope with stress.
There are several challenges with implementing such lifestyle interventions such as educating the general public and health care providers to the components of this lifestyle and in getting people to adopt these healthy lifestyle changes.
While retreat-style, intensive lifestyle programs have shown that these obstacles can be overcome, they require monetary and time investments generally not feasible for the general public.
A community-based, lifestyle program such as 'The Coronary Health Improvement Project' program offers similar potential benefits at a more reasonable cost. It does so through an intensive education (32 hours total) taught over 4 weeks, followed by an 8-week consolidation period which include live or DVD based group sessions, discussions led by a program facilitator, and medical monitoring.
Kaiser Permanente, the leading Health maintenance organization in the nation, places special focus and significant resources into preventive medicine and health promotion, providing services to thousands of plan members but none with the level of intensity of 'The Coronary Health Improvement Project'.
This study aims to determine if 'The Coronary Health Improvement Project' program can significantly improve blood sugar control in kaiser plan members with uncontrolled diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Coronary Health Improvement Project ProgramThis is the only arm in the study. They will be compared before and after |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking patients > 18 years of age, with at least 6 months of membership, who have type 2 diabetes.
- Patients must have a recent HbA1C lab value > 8.0, and have had at least 2 previous HbA1C measures during the previous 6-12 months.
- Patients with HbA1C values that are consistently > 8.0 over the previous 6-12 months will be invited to participate.
Key exclusion criteria (5 listed)
- current excessive alcohol use (drinking > 14 alcohol beverages per week for men or > 7 per week for women or > 4 per day for men or > 2 per day for women on 2 or more occasions each month)
- current use of illegal or street drugs,
- severely decreased functional capacity (shortness of breath or chest pain at rest or with minimal activity), and/or
- suicidal thoughts or depression, will
- Patients with severely limited physical ability
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 |
|---|---|---|
| Coronary Health Improvement Project ProgramThe Coronary Health Improvement Project' (CHIP; an intensive, community-based, lifestyle change program including a low saturated fat diet rich in whole, grown foods) has been shown to improve the health of diabetics through an intensive education taught over a 12 week period, but has not been studied in terms of its effect on HBAIC. Kaiser Permanente places significant resources into preventive medicine but does not have programs with the level of intensity of CHIP. This study aims to determine if Kaiser members with uncontrolled type 2 diabetes can achieve a significant improvement in their HBAIC after 12 weeks of participation in the CHIP program. | Behavioural | Intervention group |
Primary outcome
HBAIC before and after intervention
Time frame: 3 months
Baseline HbA1C will be measured within two weeks of the start of the intervention. Follow-up HbA1C will be measured at 12 weeks after the start of the intervention, as HbA1C is a measure of glycemic control over approximately 12 weeks.
5 secondary outcomes
Average weekly blood sugar
Time frame: 3 months
Lipids
Time frame: 3 months
Weight
Time frame: 3 months
waist circumference
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Mario A Robinson, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Health Improvement Project Program in people with Type 2 Diabetes, run by Kaiser Permanente 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
HBAIC before and after intervention (time frame: 3 months). 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 11 Mar 2015.