Rural Chronic Disease Risk Reduction

Chronic Disease Clinical Trial

Official title:

Reducing Chronic Disease Risk Among Rural Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05611580
• Other study ID #: STUDY00003258
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests a web-based chronic disease risk reduction intervention among rural adults.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be at least 18 years of age,

2. reside in a rural southern county (RUCC 4-9),

3. speak, write, and understand English,

4. have access to a computer with internet service or smartphone with cellular data,

5. 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

Related Conditions & MeSH terms

• Chronic Disease
• Risk Reduction

Intervention

Behavioral:
• Chronic Disease Risk Reduction
The intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions.

Locations

Country	Name	City	State
United States	Florida State University College of Nursing	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Primary	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.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Primary	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 (a = .84), norms (a = .83), and self-efficacy. (a = .79). Higher scores indicate greater indications of exercise determinants.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Primary	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. (a = .80).; Higher scores indicate greater levels of physical activity.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Primary	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.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Secondary	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 (a = .83).; Higher scores indicate better sleep quality.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Secondary	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 (a = 0.84-0.86). The items include perceptions of stress.; Higher scores indicate greater perceptions of stress.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Secondary	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 (a = .90).; Higher scores indicate greater social support.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Secondary	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 (a = 0.96); Subscales [informational (a = 0.97), emotional (a = 0.96), and encouragement (a = 0.97)].; Higher scores indicate greater social support to eat better and move more.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Secondary	Change in Well-being from Baseline to Post-intervention and 4 weeks post-intervention	Well-being Scale: Measures well-being (a = 0.92) overall, and five subscales (a = 0.79 - 0.85). Higher scores indicate greater perceptions of personal well-being.	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).