Intensive Lifestyle Intervention for Type 2 Diabetics: The KP TLC Pilot

Type 2 Diabetes Clinical Trial

— KPTLCP  

Official title:

Intensive Lifestyle Intervention for Type 2 Diabetics: The Kaiser Permanente TLC Pilot

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01484353
• Other study ID #: KPTLC Pilot
• Status: Withdrawn
• Phase: N/A
• First received: November 30, 2011
• Last updated: March 10, 2015

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. 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)

2. current use of illegal or street drugs,

3. severely decreased functional capacity (shortness of breath or chest pain at rest or with minimal activity), and/or

4. suicidal thoughts or depression, will

5. Patients with severely limited physical ability

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Coronary Health Improvement Project Program
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Riverside Medical Center	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	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"	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No