NCT00222846

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2010

Enrollment Period

5.6 years

First QC Date

September 12, 2005

Last Update Submit

May 14, 2010

Conditions

Diabetes Mellitus, Type 2Diabetic Nephropathy

Keywords

Clinical trialBehavioral researchPatient compliance

Outcome Measures

Primary Outcomes (3)

  • Physical activity CHAMPS

    Baseline, 3 and 6 months

  • Glycemic control - HbA1c

    Baseline, 3 and 6 months

  • Dietary adherence

    Baseline, 3 and 6 months

Secondary Outcomes (4)

  • Adherence to capillary glucose checks - glucometer uploads

    Baseline, 3 and 6 months

  • Weight loss

    Baseline, 3 and 6 months

  • BMI

    Baseline, 3 and 6 months

  • Waist circumference

    Baseline, 3 and 6 months

Study Arms (2)

A

ACTIVE COMPARATOR

Attention control

Behavioral: Attention control

B

EXPERIMENTAL

Intervention

Behavioral: Intervention

Interventions

Attention controlBEHAVIORAL

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

A
InterventionBEHAVIORAL

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.

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Sevick MA, Korytkowski M, Stone RA, Piraino B, Ren D, Sereika S, Wang Y, Steenkiste A, Burke LE. Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial. J Acad Nutr Diet. 2012 Aug;112(8):1147-57. doi: 10.1016/j.jand.2012.05.008.

    PMID: 22818724DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic NephropathiesPatient Compliance

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Mary A Sevick, ScD, RN

    University of PIttsburgh & Veterans Health Administration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 17, 2010

Record last verified: 2010-05

Locations

US(1)