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Diabetes and Hypertension Self Management Program

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diabetes and hypertension self-management
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

diabetes and hypertension self-management

Control

Arm Description

12-week lifestyle and disease self-management

Wait-list control

Outcomes

Primary Outcome Measures

Clinical outcomes - A1c
The difference in A1c between baseline and end of program.
Clinical outcomes - BP
The difference in BP between baseline and end of program.

Secondary Outcome Measures

Behavioral outcome - healthy eating plan; questions
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
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.

Full Information

First Posted
April 18, 2018
Last Updated
September 5, 2023
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT06034548
Brief Title
Diabetes and Hypertension Self Management Program
Official Title
Diabetes and Hypertension Self Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT with wait-listed control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diabetes and hypertension self-management
Arm Type
Experimental
Arm Description
12-week lifestyle and disease self-management
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait-list control
Intervention Type
Behavioral
Intervention Name(s)
diabetes and hypertension self-management
Intervention Description
12-weeks of 75 minutes of educational sessions
Primary Outcome Measure Information:
Title
Clinical outcomes - A1c
Description
The difference in A1c between baseline and end of program.
Time Frame
6 months after enrollment
Title
Clinical outcomes - BP
Description
The difference in BP between baseline and end of program.
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Behavioral outcome - healthy eating plan; questions
Description
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.
Time Frame
6 months after enrollment
Title
Behavioral outcome - exercise; questions
Description
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.
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranjita Misra, PhD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes and Hypertension Self Management Program

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