Latinos Combating Diabetes

NCT01831921 | Completed Results

• 2 other identifiers: IRB000225661P60MD006917
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Diabetes; Obesity; Metabolic Syndrome

Keywords

pre diabetes; obesity; weight loss; lifestyle; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Body Weight

  6, 12, 18, and 24 months

• Systolic Blood Pressure

  6, 12, 18, and 24 months

• Diastolic Blood Pressure

  6, 12, 18, and 24 months

• Fasting Glucose

  6, 12, 18, and 24 months

• Total Cholesterol

  12, and 24 months

Other Outcomes (2)

• Fasting Insulin

  6, 12, and 24 months

• Homeostasis Model of Insulin Resistance (HOMA IR)

  6, 12, and 24 months

Study Arms (2)

Lifestyle Weight-Loss

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Lifestyle Weight Loss BEHAVIORAL

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

Lifestyle Weight-Loss

Counseling BEHAVIORAL

Individual nutrition counseling will be delivered by a registered dietitian.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity; Metabolic Syndrome; Weight Loss

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Body Weight Changes

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Mara Z. Vitolins, DrPH, MPH, RDN
• Organization: Wake Forest School of Medicine

mvitolin@wakehealth.edu

(336) 716-2886

Study Officials

• Mara Z Vitolins, DrPH RDN

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 15, 2013
• Study Start: January 1, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2018

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)