Diabetes and Hypertension Self Management Program
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Aug 2018
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2018
CompletedStudy Start
First participant enrolled
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedJuly 22, 2025
July 1, 2025
2 years
April 18, 2018
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical outcomes - A1c
The difference in A1c between baseline and end of program.
6 months after enrollment
Clinical outcomes - BP
The difference in BP (systolic and diastolic) between baseline and end of program.
6 months after enrollment
Secondary Outcomes (2)
Behavioral outcome - healthy eating plan; questions
6 months after enrollment
Behavioral outcome - exercise; questions
6 months after enrollment
Study Arms (2)
diabetes and hypertension self-management
EXPERIMENTAL12-week lifestyle and disease self-management
Control
NO INTERVENTIONWait-list control
Interventions
12-weeks of 75 minutes of educational sessions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Virginia University
Morgantown, West Virginia, 26508, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ranjita Misra, PhD
West Virginia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2018
First Posted
September 13, 2023
Study Start
August 27, 2018
Primary Completion
August 12, 2020
Study Completion
August 12, 2020
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share