The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2014 |
| End Date: | February 2017 |
The aim of this project is to evaluate the reach, effectiveness, and costs of two
patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate
and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired
glucose tolerance) within a health care setting. The overall aim is consistent with the
NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and
community-based strategies for prevention of diabetes and its complications. While evidence
of lifestyle interventions that increase physical activity and improve eating habits to
achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues
to mount, the translation of these interventions into effective programs to health care
settings with modest resources remains a challenge. The proposed research project will
conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled
Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in
achieving objectively verified weight loss relative to a standard care control at
comparatively lower costs. Adult patients (18 years of age and older) at risk for developing
diabetes will be randomized to either the Choice group or the Randomization group. Those
patients randomized to the Choice group (n=240) will have the opportunity to choose one of
two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated
interactive voice response (IVR) systems targeting personal action planning to support
lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention
with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be
randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC).
SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures
include weight loss, cost, and reach of each program. Secondary outcome measures include
physical activity behavior; eating behavior; and process evaluation. It is hypothesized that
both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of
weight loss at 6, 12, and 18 months following program initiation than SC but will not differ
from one another. The investigators also hypothesize that the DVD/IVR will have broader
reach and may be more cost-effective than SG/IVR or SC.
patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate
and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired
glucose tolerance) within a health care setting. The overall aim is consistent with the
NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and
community-based strategies for prevention of diabetes and its complications. While evidence
of lifestyle interventions that increase physical activity and improve eating habits to
achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues
to mount, the translation of these interventions into effective programs to health care
settings with modest resources remains a challenge. The proposed research project will
conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled
Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in
achieving objectively verified weight loss relative to a standard care control at
comparatively lower costs. Adult patients (18 years of age and older) at risk for developing
diabetes will be randomized to either the Choice group or the Randomization group. Those
patients randomized to the Choice group (n=240) will have the opportunity to choose one of
two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated
interactive voice response (IVR) systems targeting personal action planning to support
lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention
with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be
randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC).
SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures
include weight loss, cost, and reach of each program. Secondary outcome measures include
physical activity behavior; eating behavior; and process evaluation. It is hypothesized that
both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of
weight loss at 6, 12, and 18 months following program initiation than SC but will not differ
from one another. The investigators also hypothesize that the DVD/IVR will have broader
reach and may be more cost-effective than SG/IVR or SC.
Inclusion Criteria:
- age = or > 18 years
- BMI = or > 25
Exclusion Criteria:
- Patient's medical record contains ICD-9 codes for a diagnosis of any type of
diabetes, congestive heart failure or coronary artery disease
- Pregnant or becomes pregnant during trial
- Contraindication to physical activity or weight loss
- No access to phone
- Does not speak or read English
- Patient has indicated "Do Not Contact" in Carilion patient record
- Patient is diagnosed with diabetes during the trial
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