Lifestyle Improvement Through Food and Exercise (LIFE)Study (LIFE)

Lifestyle Improvement Through Food and Exercise (LIFE) Study

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Standard of Care control group; Behavioral: Intensive education and lifestyle support

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States
      • Cook County Health Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care	Behavioral: 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.
Experimental: Intensive education and support	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Finger prick on Afinion machine	change from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total Energy Intake	24-hour dietary food recalls	change from baseline to 12 months
Physical Measures	Measurements of weight, waist circumference, and blood pressure.	change from baseline to 12 months
Medications	Participants bring all medications to the clinic visit and medication and dosage is recorded.	change from baseline to 12 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); John H. Stroger Hospital
• Investigators: Principal Investigator: Elizabeth Lynch, PhD, Rush University Medical Center

Publications and helpful links

General Publications

• Lynch EB, Mack L, Avery E, Wang Y, Dawar R, Richardson D, Keim K, Ventrelle J, Appelhans BM, Tahsin B, Fogelfeld L. Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes. J Gen Intern Med. 2019 Jul;34(7):1174-1183. doi: 10.1007/s11606-019-04894-y. Epub 2019 Apr 8.
• Lynch EB, Liebman R, Ventrelle J, Keim K, Appelhans BM, Avery EF, Tahsin B, Li H, Shapera M, Fogelfeld L. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers. Contemp Clin Trials. 2014 Nov;39(2):246-55. doi: 10.1016/j.cct.2014.09.003. Epub 2014 Sep 22.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): November 25, 2015
• Study Completion (Actual): December 2, 2015

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Self management diabetes intervention
• Other Study ID Numbers: 1R01DK092271-01 (U.S. NIH Grant/Contract); R01DK092271-01 (U.S. NIH Grant/Contract)