Latinos Combating Diabetes (La Comunidad)
Pre Diabetes, Obesity, Metabolic Syndrome
About this trial
This is an interventional prevention trial for Pre Diabetes focused on measuring pre diabetes, obesity, weight loss, lifestyle, prevention
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.
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Lifestyle Weight-Loss
Enhanced Usual Care
Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1. All participants will be seen for assessment visits as baseline, 6, and 12 months. Some participants will also complete 18 and 24 month visits, depending on the date of randomization.
Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.All participants will be seen for assessment visits as baseline, 6, and 12 months. Some participants will also complete 18 and 24 month visits, depending on the date of randomization.