- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05611580
Rural Chronic Disease Risk Reduction
Reducing Chronic Disease Risk Among Rural Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tallahassee, Florida, United States, 32306-4310
- Florida State University College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.).
Exclusion Criteria:
- not from a rural area
- younger than 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
The participant in the control group receive usual care.
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Experimental: Intervention
The participants in the intervention group received the chronic disease risk reduction intervention.
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The intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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. |
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.
|
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. |
Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
|
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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.
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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. |
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.
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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. |
Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
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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.
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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.
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Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
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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.
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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. |
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.
|
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.
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Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
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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..
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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. |
Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention..
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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.
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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. |
Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003258
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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