Clinical trial NCT01831921: Latinos Combating Diabetes
Official title: Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Obesity
Metabolic Syndrome
Keywords: pre diabetes
obesity
weight loss
lifestyle
prevention
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2013-04-15
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators plan to test two different strategies for weight loss and diabetes prevention in the Latino community in and around Forsyth County, North Carolina. The study is designed to test the hypothesis that a lifestyle weight-loss program implemented within the Latino community will have a more beneficial and clinically meaningful impact on hemoglobin A1c (HbA1c), insulin metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care condition. This lifestyle intervention will include group-based sessions promoting healthy eating, increased physical activity and weight loss. These sessions will be delivered by lay community members, known as Latino Health Advisors (LHAs). The enhanced usual care group will consist of individual counseling with are registered dietitian and uses existing community resources to assist participants in making healthier lifestyle choices.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6, 12, 18, and 24 months
Secondary outcomes:
measure: Body Weight
timeFrame: 6, 12, 18, and 24 months
measure: Systolic Blood Pressure
timeFrame: 6, 12, 18, and 24 months
measure: Diastolic Blood Pressure
timeFrame: 6, 12, 18, and 24 months
measure: Fasting Glucose
timeFrame: 6, 12, 18, and 24 months
measure: Total Cholesterol
timeFrame: 12, and 24 months
measure: High Density Lipoprotein (HDL)
timeFrame: 12, and 24 months
measure: Low Density Lipoprotein (LDL)
timeFrame: 12, and 24 months
measure: Triglycerides
timeFrame: 12, and 24 months
Other outcomes:
measure: Fasting Insulin
timeFrame: 6, 12, and 24 months
measure: Homeostasis Model of Insulin Resistance (HOMA IR)
timeFrame: 6, 12, and 24 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Z Vitolins, DrPH RDN
role: PRINCIPAL_INVESTIGATOR
References: