MedTrace Logo

Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study

NCT00222846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2010-05-17

No results posted yet for this study

Summary

This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency, (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3) those with chronic renal insufficiency regardless of glucose control. The primary aims of this study are to: (1)determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including dietary adherence, physical activity, and capillary glucose self-monitoring; (2)determine whether the intervention improves clinical outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a variety of covariates on the effectiveness of the intervention.

Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbA1c levels than attention control group participants.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetic Nephropathy

Interventions

BEHAVIORAL

Attention control

Participants attend 3 educational seminars, receive a lay diabetes journal, pedometer, and glucose monitoring supplies.

BEHAVIORAL

Intervention

Behavioral intervention of diabetes self-management paired with PDA-based monitoring of dietary intake and physical activity. Participants also receive a pedometer and glucose self-monitoring supplies.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Mary A Sevick, ScD, RN · University of PIttsburgh & Veterans Health Administration

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00222846 on ClinicalTrials.gov