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Lifestyle Intervention for Treatment of Diabetes

NCT01806727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2018-08-15

No results posted yet for this study

Summary

This study is evaluating two approaches to improving the control blood sugar, and other risk factors for heart disease in overweight and obese adults with type 2 diabetes. The first approach has participants focus on weight loss via reducing food intake and increasing physical activity, while attending weekly group sessions led by trained community health workers for 12 months. The second approach has participants receive education on diabetes self management, which focuses primarily on glucose control, while attending monthly group sessions led by a study staff member for 12 months. We are recruiting persons with type 2 diabetes who live in the Winston-Salem/Forsyth County area of North Carolina who are willing to attend sessions at the Downtown Health Plaza of Wake Forest Baptist Health. We will measure risk factors for heart disease (glucose control, blood pressure, blood cholesterol) and calculate the predicted risk of heart disease, and see which intervention lowers risk to a greater extent at 12 months, as well as 24 months.

Conditions

Interventions

BEHAVIORAL

Community Lifestyle Weight Loss (LWL)

Changing dietary and physical activity behavior to promote weight loss

BEHAVIORAL

Diabetes Self Management (DSM)

Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Alain G Bertoni, MD MPH · Wake Forest University Health Sciences

  • Jeffrey Katula, PhD · Wake Forest University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-03-30
Completion
2017-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01806727 on ClinicalTrials.gov