Latinos Combating Diabetes

Obesity Clinical Trial

— La Comunidad  

Official title:

Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831921
• Other study ID #: IRB00022566
• Secondary ID: 1P60MD006917
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Metabolic Syndrome
• Obesity
• Pre Diabetes
• Prediabetic State

Intervention

Behavioral:
• Lifestyle Weight Loss
Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
• Counseling
Individual nutrition counseling will be delivered by a registered dietitian.

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting Insulin	Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.	6, 12, and 24 months
Other	Homeostasis Model of Insulin Resistance (HOMA IR)	Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.	6, 12, and 24 months
Primary	Hemoglobin A1c	Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.	6, 12, 18, and 24 months
Secondary	Body Weight	Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.	6, 12, 18, and 24 months
Secondary	Systolic Blood Pressure	Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.	6, 12, 18, and 24 months
Secondary	Diastolic Blood Pressure	Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.	6, 12, 18, and 24 months
Secondary	Fasting Glucose	Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.	6, 12, 18, and 24 months
Secondary	Total Cholesterol	Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.	12, and 24 months
Secondary	High Density Lipoprotein (HDL)	Mean HDL in both treatment groups at 12 and 24 months will be assessed.	12, and 24 months
Secondary	Low Density Lipoprotein (LDL)	Mean LDL in both treatment groups at 12 and 24 months will be calculated.	12, and 24 months
Secondary	Triglycerides	Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.	12, and 24 months

External Links

•   Maya Angelou Center for Health Equity