Latinos Combating Diabetes

Type 2 diabetes mellitus is a major health concern in the United States, accounting for 90 to
95% of the more than 25 million diagnosed cases of diabetes in 2010. Racial and ethnic
minorities are disproportionately affected by the diabetes epidemic, specifically African
Americans, Latinos, and Native Americans. Although the cumulative evidence suggests that
lifestyle interventions to prevent diabetes can be implemented across a variety of settings
with diverse personnel, numerous barriers to widespread dissemination in minority populations
still exist. Latinos Combatiendo la Diabetes (La Comunidad) is a 225-participant randomized
trial designed to test the hypothesis that a community-based lifestyle weight-loss
intervention implemented within the accountability and structure of existing Latino
communities will have a more beneficial and clinically meaningful impact on HbA1c, insulin
metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care
condition. An economic evaluation will also be conducted to determine costs and
cost-effectiveness. One trial arm will consist of a group-based intensive lifestyle
intervention promoting healthy eating, increased physical activity and modest, yet achievable
(5-7%) weight loss delivered in an early 6-month intensive phase followed by an 18-month
maintenance phase. Latino Health Advisors (LHAs) will be utilized in the intensive
intervention arm. The control arm will consist of an individual educational intervention that
incorporates existing community resources that are available to assist residents in making
healthier lifestyle choices.

Inclusion Criteria:

- Men and women 18 years and older who reside in or near Forsyth County, North Carolina

- Self-identified as Hispanic or Latino

- Evidence of pre-diabetes: Hemoglobin A1c of 5.7-6.5%

- Body Mass Index (BMI): 25-45 kg/m2

- Potential participants must be willing to accept randomization to either the intensive
lifestyle intervention or the comparison usual care condition

Exclusion Criteria:

- Currently involved in a supervised program for weight loss

- Clinical history of diabetes or newly diagnosed diabetes at screening

- Clinical history of cardiovascular disease (CVD) occurring within the past 6 months,
including myocardial infarction, angina, coronary revascularization, stroke, transient
ischemic attack (TIA), carotid revascularization, peripheral arterial disease,
congestive heart failure. All persons with recent CVD should be participating in
cardiac rehabilitation (with appropriate supervision as indicated) to reduce their
risk of recurrence; hence, randomization might raise ethical concerns.

- Uncontrolled high blood pressure (BP): BP > 160/100. Potential participants can be
re-screened after control has been achieved.

- Pregnancy, breast feeding, or planning pregnancy within 2 years

- Other chronic disease likely to limit lifespan to less than 2-3 years, including any
cancer requiring treatment in past 5 years except non-melanoma skin cancer

- Chronic use of medicine known to significantly affect glucose metabolism (e.g.,
corticosteroids, protease inhibitors)

- Conditions/criteria likely to interfere with participation and acceptance of
randomized assignment, including the following: inability/unwillingness to give
informed consent, another household member already randomized to La Comunidad, major
psychiatric or cognitive problems (schizophrenia, dementia, self-reported active
illegal substance or alcohol abuse), participation in another research study that
would interfere with La Comunidad.