Latinos Combating Diabetes (La Comunidad)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mara Z. Vitolins, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01831921
First received: April 9, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The investigators plan to test two different strategies for weight loss and diabetes prevention in the Latino community in and around Forsyth County, NC. 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 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 Intervention
Pre Diabetes
Obesity
Metabolic Syndrome
Behavioral: Lifestyle Weight Loss
Behavioral: Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Mean change in hemoglobin A1c from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.


Secondary Outcome Measures:
  • Body Weight [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Mean change in body weight from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.

  • Blood Pressure [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Mean change in systolic and diastolic blood pressures from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.

  • Fasting Glucose [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Mean change in fasting plasma glucose from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.

  • Lipids [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Mean changes in total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides from baseline between treatment groups at 12 and 24 months will be assessed.


Other Outcome Measures:
  • Fasting Insulin [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Homeostasis model of insulin resistance (HOMA IR) [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: April 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Weight-Loss
Participants in this 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 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 an RD during months 1, 3, and 6 of phase 1.
Behavioral: Lifestyle Weight Loss
Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
Active Comparator: Enhanced Usual Care
Participants in the-enhanced usual care group will receive two individual sessions with an RD and monthly newsletters that focus on existing community resources.
Behavioral: Counseling
Individual nutrition counseling will be delivered by a registered dietitian.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 years and older who reside in or near Forsyth County, NC
  • Self-identified as Hispanic or Latino
  • Evidence of pre-diabetes: HbA1c 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, 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 > 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831921

Contacts
Contact: Donna M Kronner 336-713-4231 dkronner@wakehealth.edu
Contact: Caroline S Blackwell, BS, CCRP 336-713-4061 cblackwe@wakehealth.edu

Locations
United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Mara Z Vitolins, DrPH, MPH, RDN         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Mara Z Vitolins, DrPH MPH RD Wake Forest School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mara Z. Vitolins, Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01831921     History of Changes
Other Study ID Numbers: P60LaComunidad, 1P60MD006917
Study First Received: April 9, 2013
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Wake Forest School of Medicine:
pre diabetes
obesity
weight loss
lifestyle
prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Metabolic Syndrome X
Obesity
Prediabetic State
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014