Latinos Combating Diabetes

Not Applicable

Completed

• Conditions: Pre Diabetes; Metabolic Syndrome; Obesity
• Interventions: Behavioral: Lifestyle Weight Loss; Behavioral: Counseling

• Registration Number: NCT01831921
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-15
• Study Start: 2014-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Results First Submitted: 2018-06-27
• Results First Submitted QC: 2018-07-30
• Results First Posted: 2018-08-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Weight-Loss	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.
Enhanced Usual Care	Counseling	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6, 12, 18, and 24 months	Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	6, 12, 18, and 24 months	Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
High Density Lipoprotein (HDL)	12, and 24 months	Mean HDL in both treatment groups at 12 and 24 months will be assessed.
Low Density Lipoprotein (LDL)	12, and 24 months	Mean LDL in both treatment groups at 12 and 24 months will be calculated.
Triglycerides	12, and 24 months	Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.
Systolic Blood Pressure	6, 12, 18, and 24 months	Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Total Cholesterol	12, and 24 months	Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.
Body Weight	6, 12, 18, and 24 months	Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Fasting Glucose	6, 12, 18, and 24 months	Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States