Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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