Mitigating Cardiovascular Disease Risk Among Rural Diabetics

NCT ID: NCT04795050

Last Updated: 2025-06-27

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

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-10-31

Brief Summary

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The study explored the effects of the cardiovascular disease risk reduction intervention on diabetes fatalism, self-care activities, social support, knowledge, perceived self-managment among a rural population.

Detailed Description

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An experimental pretest-posttest control group design was used to assess the effects of a diabetes health promotion intervention among participants recruited from rural churches located in the southern United States. The intervention, called Project Power, is a culturally relevant, church-based diabetes education program that was developed by the American Diabetes Association (ADA). Participating churches were randomized to experimental and control groups using random numbers tables having numerical parity no greater than 2. Since an individual church is the unit of randomization, all of the participants in that church received the same treatment condition. Churches randomized to the intervention group received the health promotion program, and those designated to the control group received an educational brochure. Recruitment, data collection and intervention delivery, for the intervention group, occurred on the church grounds.

Conditions

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Health Promotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Project POWER

Intervention Type BEHAVIORAL

Diabetes health promotion/cardiovascular disease risk reduction educational curriculum

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Project POWER

Diabetes health promotion/cardiovascular disease risk reduction educational curriculum

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-identified African Americans aged 22 years or older, who have been diagnosed with Diabetes Mellitus, Type 1 or 2

Exclusion Criteria

* Other than African American, younger than 22 years of age
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Laurie Abbott

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Florida State University College of Nursing

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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HSC # 2018 23127

Identifier Type: -

Identifier Source: org_study_id

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