Methods

Methods

Study Population

Lower socioeconomic status and ethnic minority Spanish- and English-speaking adults who resided in the health department’s urban service area and who were at risk of developing diabetes.

Recruitment

We utilized a two-phased, community-based approach to recruit our study population.  Phase I – outreach – included diabetes education, a short Diabetes Risk Appraisal, and diabetes screening.  Phase II – trial recruitment – began concurrently for those found to be at risk of developing diabetes in Phase I by explaining the study. Those interested and eligible enrolled in the 1-year study. Methods of outreach, screening, and recruitment are reported in Santoyo-Olsson et al., 2011. The procedures for outreach and screening (Phase I) are described in the Outreach and Screening section of this website.

Study Intervention

The Live Well, Be Well lifestyle program was primarily telephone-based, with one in-person planning session and group workshops.  Counselors provided education and skills training to modify diet and increase physical activity. The program components and rationale for the program are described in Delgadillo et al., 2010. The program is described in the Lifestyle Program section of this website.

Design and Outcome Measures

A 12-month randomized controlled trial compared a lifestyle intervention group to a wait-list control group.  After completing the trial, control group participants were offered the lifestyle program.  Primary outcomes were fasting glucose, triglycerides, HDL-, LDL-cholesterol, weight, waist circumference, and systolic blood pressure (6 and 12 months).  Secondary outcomes included diet, physical activity, and health-related quality of life.  All outcomes were assessed at baseline and at 6- and 12-month follow-ups.