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Latinos Combating Diabetes (La Comunidad)

Primary Purpose

Pre Diabetes, Obesity, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lifestyle Weight Loss

Counseling

About this trial

This is an interventional prevention trial for Pre Diabetes focused on measuring pre diabetes, obesity, weight loss, lifestyle, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle Weight-Loss

Enhanced Usual Care

Arm Description

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c

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

Secondary Outcome Measures

Body Weight

Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Systolic Blood Pressure

Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Diastolic Blood Pressure

Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Fasting Glucose

Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Total Cholesterol

Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.

High Density Lipoprotein (HDL)

Mean HDL in both treatment groups at 12 and 24 months will be assessed.

Low Density Lipoprotein (LDL)

Mean LDL in both treatment groups at 12 and 24 months will be calculated.

Triglycerides

Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.

Full Information

NCT ID

NCT01831921

First Posted

April 9, 2013

Last Updated

August 16, 2019

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT01831921

Brief Title

Latinos Combating Diabetes

Acronym

La Comunidad

Official Title

Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre Diabetes, Obesity, Metabolic Syndrome

Keywords

pre diabetes, obesity, weight loss, lifestyle, prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle Weight-Loss

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Usual Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle Weight Loss

Intervention Description

Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.

Intervention Type

Behavioral

Intervention Name(s)

Counseling

Intervention Description

Individual nutrition counseling will be delivered by a registered dietitian.

Primary Outcome Measure Information:

Title

Hemoglobin A1c

Description

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

Time Frame

6, 12, 18, and 24 months

Secondary Outcome Measure Information:

Title

Body Weight

Description

Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Time Frame

6, 12, 18, and 24 months

Title

Systolic Blood Pressure

Description

Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Time Frame

6, 12, 18, and 24 months

Title

Diastolic Blood Pressure

Description

Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Time Frame

6, 12, 18, and 24 months

Title

Fasting Glucose

Description

Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Time Frame

6, 12, 18, and 24 months

Title

Total Cholesterol

Description

Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.

Time Frame

12, and 24 months

Title

High Density Lipoprotein (HDL)

Description

Mean HDL in both treatment groups at 12 and 24 months will be assessed.

Time Frame

12, and 24 months

Title

Low Density Lipoprotein (LDL)

Description

Mean LDL in both treatment groups at 12 and 24 months will be calculated.

Time Frame

12, and 24 months

Title

Triglycerides

Description

Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.

Time Frame

12, and 24 months

Other Pre-specified Outcome Measures:

Title

Fasting Insulin

Description

Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.

Time Frame

6, 12, and 24 months

Title

Homeostasis Model of Insulin Resistance (HOMA IR)

Description

Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.

Time Frame

6, 12, and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mara Z Vitolins, DrPH RDN

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest School of Medicine

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Latinos Combating Diabetes

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