Lifestyle Improvement Through Food and Exercise (LIFE)Study

Type 2 Diabetes Clinical Trial

— LIFE  

Official title:

Lifestyle Improvement Through Food and Exercise (LIFE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901952
• Other study ID #: 1R01DK092271-01
• Secondary ID: R01DK092271-01
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: May 8, 2017
• Start date: March 2012
• Est. completion date: December 2, 2015

Study information

• Verified date: May 2017
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months. We hypothesize that, on average, participants in the intervention group will achieve greater glycemic control at 12-months relative to their baseline A1c, than those in the control group.

Description:

This project is a randomized controlled trial to test an innovative lifestyle intervention to achieve sustained improvements in glycemic control among low-income African American diabetes patients. The LIFE (Lifestyle Improvement through Food and Exercise) program is a diabetes self-management program focused on diet and exercise, informed by anthropological research on models of food and health among low-income African-Americans. Pilot work demonstrated that the LIFE Program is effective in improving glycemic control among low-income African Americans at 6-months. The main goal of the current study is to determine whether the LIFE Program can achieve sustained improvements in glycemic control for 12 months. The trial will randomize low-income African American adults with diabetes to a control group, which receives standard diabetes education, or an intervention group, which receives the LIFE Program (28 group meetings with peer support telephone calls) followed by a 6-month maintenance phase (quarterly group sessions with monthly peer support phone calls). The primary aim of the proposed research is to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on change in glycemic control at 12 months. Our primary hypothesis is that patients in the intervention group will achieve a change in A1c from baseline that is less than patients in the control group. Secondary aims are to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on (a) change in glycemic control at 18 months; (b) change in physical activity and total energy intake at 12 months; (c) change in physical activity and total energy intake at 18 months; and (d) to obtain estimates needed for a subsequent trial, including weight, blood pressure, and diabetes-related hospitalizations. For secondary aims we hypothesize that a) the intervention group will achieve a mean 18-month change in A1C that is less than the change in the control group; b) at 12 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group; and c) at 18 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: December 2, 2015
• Est. primary completion date: November 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus (T2DM) and HbA1c > 7%;

• Patients must identify themselves as African American;

• Patients must be patients of Cook County Hospital ambulatory clinics;

• Primary care physician gives clearance for patient to participate in study and engage in moderate level physical activity.

Exclusion Criteria:

• BMI<18.5;

• Patient not on diabetes medication and with a HbA1c reading less than 7%

• End-stage renal disease, stroke with paresis, congestive heart failure (NYHA class 2-4), or other major end-organ complication of diabetes;

• Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);

• Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);

• Unable to give informed consent;

• Under the age of 18;

• Has no access to a telephone (Phone contact is a critical component of the intervention).

• Cannot walk 2 blocks without stopping and resting.

• Impaired cognitive function as determined by mini-mental test.

• Lives in the same household as an active LIFE participant.

• Presence of sickle cell trait

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Intensive education and lifestyle support
Group classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months.
• Standard of Care control group
Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months.

Locations

Country	Name	City	State
United States	Cook County Health Clinics	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	John H. Stroger Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Finger prick on Afinion machine	change from baseline to 12 months
Secondary	Physical Activity	An accelerometer is worn by participants for seven days. International-Physical Activity Questionnaire is administered at baseline, 6 months, 1 year, and 18 months.	change from baseline to 12 months
Secondary	Total Energy Intake	24-hour dietary food recalls	change from baseline to 12 months
Secondary	Physical Measures	Measurements of weight, waist circumference, and blood pressure.	change from baseline to 12 months
Secondary	Medications	Participants bring all medications to the clinic visit and medication and dosage is recorded.	change from baseline to 12 months