NCT01901952

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2015

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2015

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

July 12, 2013

Last Update Submit

May 8, 2017

Conditions

Type 2 Diabetes

Keywords

Self management diabetes intervention

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Finger prick on Afinion machine

    change from baseline to 12 months

Secondary Outcomes (4)

  • Physical Activity

    change from baseline to 12 months

  • Total Energy Intake

    change from baseline to 12 months

  • Physical Measures

    change from baseline to 12 months

  • Medications

    change from baseline to 12 months

Study Arms (2)

Standard of care

ACTIVE COMPARATOR
Behavioral: Standard of Care control group

Intensive education and support

EXPERIMENTAL
Behavioral: Intensive education and lifestyle support

Interventions

Intensive education and lifestyle supportBEHAVIORAL

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.

Intensive education and support
Standard of Care control groupBEHAVIORAL

Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months.

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cook County Health Clinics

Chicago, Illinois, United States

Location

Related Publications (2)

  • 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.

    PMID: 30963440DERIVED

  • 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.

    PMID: 25245954DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Elizabeth Lynch, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 17, 2013

Study Start

March 1, 2012

Primary Completion

November 25, 2015

Study Completion

December 2, 2015

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)