Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study (ENHANCE)

Enhancing Adherence in Type 2 Diabetics

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetic Nephropathy
• Intervention / Treatment: Behavioral: Attention control; Behavioral: Intervention

Detailed Description

This randomized study, the ENHANCE Study (Enhancing Adherence to Diabetes Self-Management) 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) HbA1c < 8% and no concurrent chronic renal insufficiency, (2) HbA1c>8% and no chronic renal insufficiency, and (3) those with evidence of 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: 1.a. dietary adherence, as measured by self-report using dietary recalls and the Nutrient Data System, 1.b. physical activity as measured by the CHAMPS Physical Activity Questionnaire as well as pedometer readings, and 1.c. adherence to capillary glucose self-monitoring as assessed by the FreeStyle monitor.
2. . Determine whether the intervention improves clinical outcome measures including: 2.a. glycosylated hemoglobin levels (HbA1c), 2.b. weight loss, 2.c. anthropometrics.
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.
5. . Explore the impact of a variety of covariates (medications, depression, social support, severity of disease, and general health and sociodemographic characteristics, clinic from which they were recruited, health literacy, and trust in research) 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 behavioral 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.

The 6-month intervention includes group classes, held weekly during months 1&2, biweekly during months 3&4, and monthly during month 5&6. Classes focus on building a sense of mastery over the diabetes regimen and features the use of PDA-base dietary self-monitoring. Intervention group participants are compared to an attention care group, that receives monthly contacts. Measurements are made at baseline, 3, and 6 months.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Study subjects will include those with: type 2 diabetes mellitus defined according to the 1997 ADA criteria and age of 18 years or greater. We will sample from three different patient populations: (1) 96 individuals who have HbA1c < 8%, and no evidence of chronic renal insufficiency (a serum creatinine <1.3mg/dl for women and <1.5mg/dl for men). (2) 96 individuals with HbA1c > 8%, and no evidence of chronic renal insufficiency, and (3) 96 individuals with evidence of chronic renal insufficiency (a serum creatinine >1.3mg/dl for women and >1.5mg/dl for men, but who have not yet progressed to dialysis), regardless of HbA1c level.

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Exclusion Criteria: Exclusion criteria were selected to enhance safety and ability to complete the study protocol. They include: (1) history of hypoglycemic coma/seizure within the last 12 months, (2) hypoglycemia requiring 3rd party assistance within the last 3 months, (3) history consistent with type 1 diabetes, (4) unwillingness to do capillary blood testing using the FreeStyle monitor, (5) unwillingness or inability to participate in scheduled group classes or individual counseling sessions, (7) subjects currently on renal dialysis, (8) any factors likely to preclude adherence to the study protocol including dementia, alcohol or substance abuse, plan to move within the next 8 months, lack of support from the subject's primary health care provider (i.e. PCP is aware of significant risks such as extreme variation in blood glucoses and/or comorbidities that would make participation in the study unsafe), failure to obtain informed consent from the participant, current participation in another clinical trial, and (9) subjects who are not available by telephone during the hours of 8am to 6pm.

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Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Attention control	Behavioral: Attention control; Participants attend 3 educational seminars, receive a lay diabetes journal, pedometer, and glucose monitoring supplies.
Experimental: B; Intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity CHAMPS	Baseline, 3 and 6 months
Glycemic control - HbA1c	Baseline, 3 and 6 months
Dietary adherence	Baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Mary A Sevick, ScD, RN, University of PIttsburgh & Veterans Health Administration

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 17, 2010
• Last Update Submitted That Met QC Criteria: May 14, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Clinical trial; Behavioral research; Patient compliance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetic Nephropathies
• Other Study ID Numbers: NIH-R01-NR008792