Clinical trial NCT01484353: Intensive Lifestyle Intervention for Type 2 Diabetics: The KP TLC Pilot
Official title: Intensive Lifestyle Intervention for Type 2 Diabetics: The Kaiser Permanente TLC Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HBAIC before and after intervention
timeFrame: 3 months
Secondary outcomes:
measure: Average weekly blood sugar
timeFrame: 3 months
measure: Lipids
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
measure: waist circumference
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Mario A Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: