Diabetes and Hypertension Self Management Program

• Sponsor: West Virginia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06034548
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.5
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Hypertension	Behavioral: diabetes and hypertension self-management	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: RCT with wait-listed controlRCT with wait-listed control
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Diabetes and Hypertension Self Management Program
• Actual Study Start Date: Aug 27, 2018
• Actual Primary Completion Date: Aug 12, 2020
• Actual Study Completion Date: Aug 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diabetes and hypertension self-management 12-week lifestyle and disease self-management	Behavioral: diabetes and hypertension self-management; 12-weeks of 75 minutes of educational sessions
No Intervention: Control Wait-list control

Outcome Measures

Primary Outcome Measures

1. Clinical outcomes - A1c [6 months after enrollment]

   The difference in A1c between baseline and end of program.

2. Clinical outcomes - BP [6 months after enrollment]

   The difference in BP between baseline and end of program.

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University	Morgantown	West Virginia	United States	26508

Sponsors and Collaborators

• West Virginia University

Investigators

• Principal Investigator: Ranjita Misra, PhD, West Virginia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ranjita Misra, Principal Investigator, West Virginia University
• ClinicalTrials.gov Identifier: NCT06034548
• Other Study ID Numbers: 1607202245
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 13, 2023