Latinos Combating Diabetes (La Comunidad)

• ClinicalTrials.gov Identifier: NCT01831921
• Recruitment Status: Completed
• First Posted: April 15, 2013
• Results First Posted: August 28, 2018
• Last Update Posted: August 28, 2019
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

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.

Condition or disease	Intervention/treatment	Phase
Pre Diabetes; Obesity; Metabolic Syndrome	Behavioral: Lifestyle Weight Loss; Behavioral: Counseling	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)
• Actual Study Start Date: January 2014
• Actual Primary Completion Date: June 30, 2017
• Actual Study Completion Date: June 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hemoglobin A1c [ Time Frame: 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 :

1. Body Weight [ Time Frame: 6, 12, 18, and 24 months ]
   Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.
2. Systolic Blood Pressure [ Time Frame: 6, 12, 18, and 24 months ]
   Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
3. Diastolic Blood Pressure [ Time Frame: 6, 12, 18, and 24 months ]
   Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
4. Fasting Glucose [ Time Frame: 6, 12, 18, and 24 months ]
   Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.
5. Total Cholesterol [ Time Frame: 12, and 24 months ]
   Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.
6. High Density Lipoprotein (HDL) [ Time Frame: 12, and 24 months ]
   Mean HDL in both treatment groups at 12 and 24 months will be assessed.
7. Low Density Lipoprotein (LDL) [ Time Frame: 12, and 24 months ]
   Mean LDL in both treatment groups at 12 and 24 months will be calculated.
8. Triglycerides [ Time Frame: 12, and 24 months ]
   Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.

Other Outcome Measures:

1. Fasting Insulin [ Time Frame: 6, 12, and 24 months ]
   Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.
2. Homeostasis Model of Insulin Resistance (HOMA IR) [ Time Frame: 6, 12, and 24 months ]
   Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Mara Z Vitolins, DrPH RDN; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Study Protocol and Statistical Analysis Plan  [PDF] February 15, 2017

More Information

Additional Information:

Maya Angelou Center for Health Equity 

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01831921
• Other Study ID Numbers: IRB00022566; 1P60MD006917 ( U.S. NIH Grant/Contract )
• First Posted: April 15, 2013
• Results First Posted: August 28, 2018
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

pre diabetes; obesity; weight loss; lifestyle; prevention

Additional relevant MeSH terms:

Diabetes Mellitus; Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Hyperglycemia