title: 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.
abstract: The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group.
authors.affiliation: Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL 60612, USA. Electronic address: elizabeth_lynch@rush.edu.
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Lynch
authors.affiliation: Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL 60612, USA. Electronic address: rebecca_liebman@rush.edu.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Liebman
authors.affiliation: Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL 60612, USA. Electronic address: jennifer_ventrelle@rush.edu.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ventrelle
authors.affiliation: Department of Nutrition, Rush University Medical Center, 1700 West Van Buren, Suite 425, Chicago, IL 60612 USA. Electronic address: kathy_keim@rush.edu.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Keim
authors.affiliation: Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL 60612, USA. Electronic address: brad_appelhans@rush.edu.
authors.forename: Bradley M
authors.initials: BM
authors.lastname: Appelhans
authors.affiliation: Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL 60612, USA. Electronic address: elizabeth_f_avery@rush.edu.
authors.forename: Elizabeth F
authors.initials: EF
authors.lastname: Avery
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, 1900 W Polk Street, Suite 812, Chicago, IL 60612, USA. Electronic address: btahsin@cookcountyhhs.org.
authors.forename: Bettina
authors.initials: B
authors.lastname: Tahsin
authors.affiliation: Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL 60612, USA. Electronic address: hong_li2@rush.edu.
authors.forename: Hong
authors.initials: H
authors.lastname: Li
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, 1900 W Polk Street, Suite 812, Chicago, IL 60612, USA. Electronic address: mshapera@cookcountyhhs.org.
authors.forename: Merle
authors.initials: M
authors.lastname: Shapera
authors.affiliation: Division of Endocrinology, Cook County Health & Hospitals System, 1900 W Polk Street, Suite 812, Chicago, IL 60612, USA. Electronic address: lfogelfeld@cookcountyhhs.org.
authors.forename: Leon
authors.initials: L
authors.lastname: Fogelfeld
mesh_terms: D061725:Accelerometry; D000293:Adolescent; D000328:Adult; D001741:Black or African American; D001786:Blood Glucose; D015992:Body Mass Index; D003376:Counseling; D054521:Cultural Competency; D003924:Diabetes Mellitus, Type 2 / Q000208:ethnology* / Q000628:therapy*; D004032:Diet; D015444:Exercise; D005247:Feeding Behavior; D005260:Female; D015438:Health Behavior; D006266:Health Education / Q000458:organization & administration*; D057220:Health Literacy; D006293:Health Promotion / Q000458:organization & administration; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D012107:Research Design; D064876:Safety-net Providers / Q000458:organization & administration*; D012648:Self Care; D012944:Social Support; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: African American; Community-based intervention; Glycemic control; Health disparities; Self-management intervention; Type 2 diabetes