Diabetes and Hypertension Self Management Program

NCT ID: NCT06034548

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2020-08-12

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT with wait-listed control
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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diabetes and hypertension self-management

12-week lifestyle and disease self-management

Group Type EXPERIMENTAL

diabetes and hypertension self-management

Intervention Type BEHAVIORAL

12-weeks of 75 minutes of educational sessions

Control

Wait-list control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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diabetes and hypertension self-management

12-weeks of 75 minutes of educational sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ranjita Misra, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1607202245

Identifier Type: -

Identifier Source: org_study_id

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