Chronic DiseaseNCT05611580
Rural Chronic Disease Risk Reduction
A study testing Chronic Disease Risk Reduction in people with Chronic Disease and Risk Reduction, run by Florida State University at 1 site in United States.
Trial summary
This study tests a web-based chronic disease risk reduction lifestyle medicine intervention among rural adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Risk Reduction
- What is being tested?
- Chronic Disease Risk Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 31 May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 18 years of age,
- reside in a rural southern county (RUCC 4-9),
- speak, write, and understand English,
- have access to a computer with internet service or smartphone with cellular data,
- have the ability to access the Zoom platform, and f) have at least one chronic disease risk factor or diagnosis (diabetes, prediabetes, overweight, smoker, hypertension, family history of cancer, diabetes, heart disease, elevated cholesterol level, overweight or obese, etc.).
Who cannot join
- not from a rural area
- younger than 18
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
Official title: Reducing Chronic Disease Risk Among Rural Adults
This study tests a web-based chronic disease risk reduction lifestyle medicine intervention among rural adults.
Read the detailed description
The impact of chronic diseases has important implications for public health presently and in the future. The prevalence of chronic diseases is expected to rise with subsequent increases in mortality, morbidity, and health care costs. This proposed pilot project involves testing an adapted evidence-based lifestyle medicine (health promotion and disease risk reduction) curriculum using a web-based delivery format and determine its impact and efficacy among rural participants. The project is expected to contribute to improved human health by promoting healthy behaviors that reduce the development, progression, and exacerbation of chronic diseases.
- Conditions
- Chronic Disease, Risk Reduction
- Being tested
- Chronic Disease Risk Reduction
- Keywords
- chronic disease, health promotion, risk reduction
- Medical subject headings
- Chronic Disease, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Risk ReductionBehavioural
The intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The participant in the control group receive usual care. |
| Intervention | Experimental | The participants in the intervention group received the chronic disease risk reduction intervention. Receives: Behavioral: Chronic Disease Risk Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Produce and Vegetable Consumption from Baseline to Post-intervention and 4 weeks post-intervention
Theory of Planned Behavior 5-a-day Questionnaire: The 12-item scale for measuring produce consumption had adequate internal reliability for attitudes (Cronbach"s a = .79), norms (a = .77), self-efficacy (a = .81), and intentions (a = .74) when tested among a diverse population. The range of possible scores for each of the subscales for this instrument varied for attitudes (3 to 28), norms and self-efficacy (3 to 21), and intentions (1 to 14).
Higher scores indicate greater compliance with dietary recommendations.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Secondary outcomes (9)
Change in Sleep from Baseline to Post-intervention and 4 weeks post-intervention
The Pittsburgh Sleep Quality Index (PSQI): Sleep habits, Perceptions of sleep quality, quantity, and difficulties falling and staying asleep. 9-item Likert scale had good internal reliability (α = .83).
Higher scores indicate better sleep quality.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Stress from Baseline to Post-intervention and 4 weeks post-intervention
Perceived Stress Scale: A 10-item, 5-point Likert scale, that had excellent internal consistency (α = 0.84-0.86). The items include perceptions of stress.
Higher scores indicate greater perceptions of stress.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Social Support from Baseline to Post-intervention and 4 weeks post-intervention
Interpersonal Support Evaluation List-12 (ISEL-12): Perceived belonging, tangible, and appraisal support. 12-item Likert scale had excellent reliability (α = .90).
Higher scores indicate greater social support.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Social Support to Eat Better and Move More from Baseline to Post-intervention and 4 weeks post-intervention
Social Support to Eat Better and Move More: Support from friends; Overall (α = 0.96); Subscales [informational (α = 0.97), emotional (α = 0.96), and encouragement (α = 0.97)].
Higher scores indicate greater social support to eat better and move more.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Well-being from Baseline to Post-intervention and 4 weeks post-intervention
Well-being Scale: Measures well-being (α = 0.92) overall, and five subscales (α = 0.79 - 0.85). Higher scores indicate greater perceptions of personal well-being.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Dietary Fat Intake from Baseline to Post-intervention and 4 weeks post-intervention
Theory of Planned Behavior Dietary Fat Measure: The 14-item instrument containing Likert-type subscales used to ascertain dietary fat attitudes (a = .95), norms (a = .92), self-efficacy (a = .86), and intentions (a = .94) was considered highly reliable. The range of potential scores included 2 items for attitudes (2 to 14), 4 items for norms (4 to 28), 5 items for self-efficacy (5 to 35), and 3 items for intentions (3 to 21).
Higher scores indicate greater compliance with following dietary fat recommendations.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Exercise from Baseline to Post-intervention and 4 weeks post-intervention
Theory of Planned Behavior Exercise Questionnaire: 10-item scale used to measure exercise evidenced good reliability for attitude (α = .84), norms (α = .83), and self-efficacy. (α = .79). Higher scores indicate greater indications of exercise determinants.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Health Habits and Knowledge from Baseline to Post-intervention and 4 weeks post-intervention
Intervention-specific; Diet, exercise, confidence, smoking, alcohol; knowledge of CVD \& risk factors. Both scales (Health Habits and Health Knowledge) range from 0-100.
Higher scores indicate greater knowledge about health information and performance of those behaviors.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention..
Change in Physical Activity from Baseline to Post-intervention and 4 weeks post-intervention
International Physical Activity Quesionnaire (IPAQ): Measures physical activities and exercise intensity and time levels, work-related physical activity, transportation-related, etc. (α = .80).
Higher scores indicate greater levels of physical activity.
Measured: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jan 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT05611580
- Sponsor's protocol ID
- STUDY00003258
- Status last verified
- Jul 2025
- First submitted
- 31 Oct 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Chronic Disease Risk Among Rural Adults
- ClinicalTrials.gov ID
- NCT05611580
- Acronym / sponsor ID
- STUDY00003258
- Conditions
- Chronic Disease, Risk Reduction
- Keywords
- chronic disease, health promotion, risk reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 10 Nov 2022 (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.
This study tests a web-based chronic disease risk reduction lifestyle medicine intervention among rural adults.
Detailed description
The impact of chronic diseases has important implications for public health presently and in the future. The prevalence of chronic diseases is expected to rise with subsequent increases in mortality, morbidity, and health care costs. This proposed pilot project involves testing an adapted evidence-based lifestyle medicine (health promotion and disease risk reduction) curriculum using a web-based delivery format and determine its impact and efficacy among rural participants. The project is expected to contribute to improved human health by promoting healthy behaviors that reduce the development, progression, and exacerbation of chronic diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The participant in the control group receive usual care. |
| Intervention | Experimental | Behavioral: Chronic Disease Risk ReductionThe participants in the intervention group received the chronic disease risk reduction intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 18 years of age,
- reside in a rural southern county (RUCC 4-9),
- speak, write, and understand English,
- have access to a computer with internet service or smartphone with cellular data,
- have the ability to access the Zoom platform, and f) have at least one chronic disease risk factor or diagnosis (diabetes, prediabetes, overweight, smoker, hypertension, family history of cancer, diabetes, heart disease, elevated cholesterol level, overweight or obese, etc.).
Key exclusion criteria (2 listed)
- not from a rural area
- younger than 18
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 |
|---|---|---|
| Chronic Disease Risk ReductionThe intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions. | Behavioural | Intervention |
Primary outcome
Change in Produce and Vegetable Consumption from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Theory of Planned Behavior 5-a-day Questionnaire: The 12-item scale for measuring produce consumption had adequate internal reliability for attitudes (Cronbach"s a = .79), norms (a = .77), self-efficacy (a = .81), and intentions (a = .74) when tested among a diverse population. The range of possible scores for each of the subscales for this instrument varied for attitudes (3 to 28), norms and self-efficacy (3 to 21), and intentions (1 to 14). Higher scores indicate greater compliance with dietary recommendations.
9 secondary outcomes
Change in Sleep from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Stress from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Social Support from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Social Support to Eat Better and Move More from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Well-being from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Dietary Fat Intake from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Exercise from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
Change in Health Habits and Knowledge from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention..
Change in Physical Activity from Baseline to Post-intervention and 4 weeks post-intervention
Time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
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 4 Jul 2025.
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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 Chronic Disease Risk Reduction in people with Chronic Disease and Risk Reduction, 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 5 inclusion and 2 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 4 Jul 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?
Change in Produce and Vegetable Consumption from Baseline to Post-intervention and 4 weeks post-intervention (time frame: Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.). 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 4 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.