Health PromotionNCT04795050
Mitigating Cardiovascular Disease Risk Among Rural Diabetics
A study testing Project POWER in people with Health Promotion, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Project POWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified African Americans aged 22 years or older, who have been diagnosed with Diabetes Mellitus, Type 1 or 2
Who cannot join
- Other than African American, younger than 22 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University College of Nursing
Tallahassee, Florida, 32306-4310
About this study
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.
Read the detailed description
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
- Health Promotion
- Being tested
- Project POWER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project POWERBehavioural
Diabetes health promotion/cardiovascular disease risk reduction educational curriculum
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Project POWER |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-care Activities
The Summary of Diabetes Self-care Activities (SDSCA) (Toobert, Hampson, \& Glascow, 2000) includes multiple choice questions and items about self-care behaviors answered in days per week. The internal consistency of the instrument is adequate (α = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.
Measured: Baseline
Diabetes Knowledge
The Revised Diabetes Knowledge Test: Michigan Diabetes Research Center (Fitzgerald et al., 2016) is a 23-item multiple choice diabetes knowledge test. The scale has good reliability for both the general test (α = .77) and the insulin use subscale (α = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.
Measured: Baseline
Change from Baseline Diabetes Self-care Activities at Three Weeks
The Summary of Diabetes Self-care Activities (SDSCA) (Toobert, Hampson, \& Glascow, 2000) includes multiple choice questions and items about self-care behaviors answered in days per week. The internal consistency of the instrument is adequate (α = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.
Measured: Three weeks after baseline
Change from Baseline Diabetes Knowledge at Three Weeks
The Revised Diabetes Knowledge Test: Michigan Diabetes Research Center (Fitzgerald et al., 2016) is a 23-item multiple choice diabetes knowledge test. The scale has good reliability for both the general test (α = .77) and the insulin use subscale (α = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.
Measured: Three weeks after baseline
Secondary outcomes (6)
Diabetes Fatalism
The Diabetes Fatalism Scale (Egede \& Ellis, 2010) is a 12-item, 6-point Likert scale that measures the three constructs associated with diabetes fatalism: emotional distress, coping, and self-efficacy. The measure has excellent internal consistency (α = .83). The total score ranged from a minimum of 12 points and maximum of 72 points. Higher scores indicated greater diabetes fatalism.
Measured: Baseline and three weeks later
Perceived Diabetes Self-Management
The Perceived Diabetes Self-Management Scale (PDSMS) (Wallston, Rothman, \& Cherrington, 2007) is an 8-item, Likert scale-type tool with responses that range from "Strongly Disagree" (1) to "Strongly Agree" (5) for each of the 8 items. The tool measures self-care perceptions and has excellent internal consistency (α = .83). The total score ranged from a minimum of 8 points and maximum of 40. Higher scores indicate greater perceptions of diabetes self-management.
Measured: Baseline and three weeks later
Social Support
The Medical Outcomes Study Social Support Survey (Sherbourne \& Stewart, 1991) is a instrument that has one fill-in-the-blank and 19 Likert scale, 5-point items that range from "None of the Time" (1) to "All of the Time" (5). The four social support subscales have excellent reliabilities (α = .91 - .97). The possibility of ranges were between 19 and 95, and higher scores indicated higher social support.
Measured: Baseline and three weeks later
Change from Baseline Diabetes Fatalism at Three Weeks
The Diabetes Fatalism Scale (Egede \& Ellis, 2010) is a 12-item, 6-point Likert scale that measures the three constructs associated with diabetes fatalism: emotional distress, coping, and self-efficacy. The measure has excellent internal consistency (α = .83). The total score ranged from a minimum of 12 points and maximum of 72 points. Higher scores indicated greater diabetes fatalism.
Measured: Baseline and three weeks later
Change from Baseline Perceived Diabetes Self-Management at Three Weeks
The Perceived Diabetes Self-Management Scale (PDSMS) (Wallston, Rothman, \& Cherrington, 2007) is an 8-item, Likert scale-type tool with responses that range from "Strongly Disagree" (1) to "Strongly Agree" (5) for each of the 8 items. The tool measures self-care perceptions and has excellent internal consistency (α = .83). The total score ranged from a minimum of 8 points and maximum of 40. Higher scores indicate greater perceptions of diabetes self-management.
Measured: Baseline and three weeks later
Change from Baseline Social Support at Three Weeks
The Medical Outcomes Study Social Support Survey (Sherbourne \& Stewart, 1991) is a instrument that has one fill-in-the-blank and 19 Likert scale, 5-point items that range from "None of the Time" (1) to "All of the Time" (5). The four social support subscales have excellent reliabilities (α = .91 - .97). The possibility of ranges were between 19 and 95, and higher scores indicated higher social support.
Measured: Baseline and three weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 May 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Abbott, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795050
- Sponsor's protocol ID
- HSC # 2018 23127
- Status last verified
- Jun 2025
- First submitted
- 9 Mar 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Cardiovascular Disease Risk Among Rural Diabetics
- ClinicalTrials.gov ID
- NCT04795050
- Acronym / sponsor ID
- HSC # 2018 23127
- Conditions
- Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Project POWER |
| Control | No intervention | – |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-identified African Americans aged 22 years or older, who have been diagnosed with Diabetes Mellitus, Type 1 or 2
Key exclusion criteria (1 listed)
- Other than African American, younger than 22 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project POWERDiabetes health promotion/cardiovascular disease risk reduction educational curriculum | Behavioural | Intervention |
Primary outcome
Diabetes Self-care Activities
Time frame: Baseline
The Summary of Diabetes Self-care Activities (SDSCA) (Toobert, Hampson, \& Glascow, 2000) includes multiple choice questions and items about self-care behaviors answered in days per week. The internal consistency of the instrument is adequate (α = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.
Diabetes Knowledge
Time frame: Baseline
The Revised Diabetes Knowledge Test: Michigan Diabetes Research Center (Fitzgerald et al., 2016) is a 23-item multiple choice diabetes knowledge test. The scale has good reliability for both the general test (α = .77) and the insulin use subscale (α = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.
Change from Baseline Diabetes Self-care Activities at Three Weeks
Time frame: Three weeks after baseline
The Summary of Diabetes Self-care Activities (SDSCA) (Toobert, Hampson, \& Glascow, 2000) includes multiple choice questions and items about self-care behaviors answered in days per week. The internal consistency of the instrument is adequate (α = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.
Change from Baseline Diabetes Knowledge at Three Weeks
Time frame: Three weeks after baseline
The Revised Diabetes Knowledge Test: Michigan Diabetes Research Center (Fitzgerald et al., 2016) is a 23-item multiple choice diabetes knowledge test. The scale has good reliability for both the general test (α = .77) and the insulin use subscale (α = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.
6 secondary outcomes
Diabetes Fatalism
Time frame: Baseline and three weeks later
Perceived Diabetes Self-Management
Time frame: Baseline and three weeks later
Social Support
Time frame: Baseline and three weeks later
Change from Baseline Diabetes Fatalism at Three Weeks
Time frame: Baseline and three weeks later
Change from Baseline Perceived Diabetes Self-Management at Three Weeks
Time frame: Baseline and three weeks later
Change from Baseline Social Support at Three Weeks
Time frame: Baseline and three weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Health Promotion
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project POWER in people with Health Promotion, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-care Activities (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.