N/A
Completed N=225
Latinos Combating Diabetes
Pre Diabetes · Obesity · Metabolic Syndrome
Source: ClinicalTrials.gov NCT01831921 ↗
Enrolled (actual)
225
Serious AEs
2.2%
Results posted
Aug 2018
Primary outcomePrimary: Hemoglobin A1c — 5.9; 5.8; 5.9; 5.9 percent HbA1c
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
5.9; 5.8; 5.9; 5.9; 5.9; 5.9 | — |
| SECONDARY Body Weight |
79.2; 77.4; 79.7; 79.1; 79.9; 78.7 | — |
| SECONDARY Systolic Blood Pressure |
117.0; 113.7; 116.7; 114.3; 117.1; 115.6 | — |
| SECONDARY Diastolic Blood Pressure |
69.5; 69.2; 70.0; 71.2; 69.3; 70.4 | — |
| SECONDARY Fasting Glucose |
96.3; 96.3; 98.1; 96.1; 98.0; 98.6 | — |
| SECONDARY Total Cholesterol |
181.1; 180.3; 184.7; 174.4 | — |
| SECONDARY High Density Lipoprotein (HDL) |
47.3; 47.5; 46.8; 45.5 | — |
| SECONDARY Low Density Lipoprotein (LDL) |
106.7; 106.5; 108.3; 101.5 | — |
| SECONDARY Triglycerides |
139.7; 131.3; 147.7; 139.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01831921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.