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

NCT ID: NCT01484353

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

This is the only arm in the study. They will be compared before and after

Group Type: EXPERIMENTAL

Coronary Health Improvement Project Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario A Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Countries

United States

Other Identifiers

KPTLC Pilot

Identifier Type: -

Identifier Source: org_study_id