Latinos Combating Diabetes (La Comunidad)

Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Pre Diabetes
• Intervention / Treatment: Behavioral: Lifestyle Weight Loss; Behavioral: Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Weight-Loss; 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.	Behavioral: Lifestyle Weight Loss; Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
Active Comparator: Enhanced Usual Care; 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.	Behavioral: Counseling; Individual nutrition counseling will be delivered by a registered dietitian.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Total Cholesterol	Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.	12, and 24 months
High Density Lipoprotein (HDL)	Mean HDL in both treatment groups at 12 and 24 months will be assessed.	12, and 24 months
Low Density Lipoprotein (LDL)	Mean LDL in both treatment groups at 12 and 24 months will be calculated.	12, and 24 months
Triglycerides	Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.	12, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Mara Z Vitolins, DrPH RDN, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: obesity; prevention; weight loss; lifestyle; pre diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Diabetes Mellitus; Metabolic Syndrome; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IRB00022566; 1P60MD006917 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No