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

NCT01484353 | Withdrawn

• 1 other identifier: KPTLC Pilot
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Average weekly blood sugar

  3 months

• Lipids

  3 months

• Weight

  3 months

• waist circumference

  3 months

• Blood pressure

  3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Behavioral: Coronary Health Improvement Project Program

Interventions

Coronary Health Improvement Project Program 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mario A Robinson, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (1)