Diabetes Mellitus, Type 2, Hypertension
Conditions
Brief summary
The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week diabetes and hypertension self-management program using trained health coaches.
Detailed description
West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes self-management programs are hospital or clinic based and none are tailored to address the unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There is a critical need for new and creative community-based, culturally appropriate self-management programs in this medically underserved state. This study will use a wait-listed randomized control trial (RCT) design, using evidence-based interventions, to improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group (N=35), based on an allocation sequence generated by the biostatistician using a randomly varying block randomization method to ensure equal distribution among treatment groups.
Interventions
BEHAVIORALdiabetes and hypertension self-management
12-weeks of 75 minutes of educational sessions
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
RCT with wait-listed control
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* English speaking adults \>= 18 years of age; * co-occurring diagnosis of T2DM and HTN; * body mass index \>= 25.0 * willing to be randomized and complete all assessments.
Exclusion criteria
* currently pregnant or breastfeeding; * diagnosed with a severe mental illness; * have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet; * inability to complete the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes - BP | 6 months after enrollment | The difference in BP (systolic and diastolic) between baseline and end of program. |
| Clinical outcomes - A1c | 6 months after enrollment | The difference in A1c between baseline and end of program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral outcome - healthy eating plan; questions | 6 months after enrollment | Dietary analysis will be based on following a healthy eating plan at baseline and completion of the Program. All participants will be assessed regarding the number of days they followed a healthful eating plan using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. How many of the last SEVEN DAYS have you followed a healthful eating plan? 0 1 2 3 4 5 6 7. Changes in mean number of days followed a healthy eating plan will be assessed at baseline and at the completion of the program. |
| Behavioral outcome - exercise; questions | 6 months after enrollment | All participants will be assessed regarding the number of days they exercise using two survey questions from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. The description of the questions are as follow: Q1. On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? (please list the total minutes of continuous activity, including walking) 0 1 2 3 4 5 6 7 & Q2. On how many of the last SEVEN DAYS did you participate in a specific exercise session (such as swimming, walking, biking) other than what you do around the house or as part of your work? 0 1 2 3 4 5 6 7). The total exercise score will be calculated by the mean number of days for the two questions). Changes in mean number of days exercised will be assessed at baseline and at the completion of the program. |
Countries
United States
Outcome results
None listed