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

This study has been withdrawn prior to enrollment.
(This study was cancelled.)
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01484353
First received: November 30, 2011
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Coronary Health Improvement Project Program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Lifestyle Intervention for Type 2 Diabetics: The Kaiser Permanente TLC Pilot

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • HBAIC before and after intervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Average weekly blood sugar [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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"

  • Lipids [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • waist circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Arms Assigned Interventions
Experimental: Intervention group
This is the only arm in the study. They will be compared before and after
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484353

Locations
United States, California
Kaiser Permanente Riverside Medical Center
Riverside, California, United States, 92505
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Mario A Robinson, MD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01484353     History of Changes
Other Study ID Numbers: KPTLC Pilot
Study First Received: November 30, 2011
Last Updated: October 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014