Rural Chronic Disease Risk Reduction

Not Applicable

Active, not recruiting

• Conditions: Risk Reduction; Chronic Disease
• Interventions: Behavioral: Chronic Disease Risk Reduction

• Registration Number: NCT05611580
• Lead Sponsor: Florida State University

Brief Summary

This study tests a web-based chronic disease risk reduction 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 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 Timeline

• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Study Start: 2023-01-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Chronic Disease Risk Reduction	The participants in the intervention group received the chronic disease risk reduction intervention.

Primary Outcome Measures

Name	Time	Method
Change in Health Habits and Knowledge from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Dietary Fat Intake from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Produce and Vegetable Consumption from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Exercise from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Physical Activity from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.

Secondary Outcome Measures

Name	Time	Method
Change in Well-being from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Social Support from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Stress from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Social Support to Eat Better and Move More from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.
Change in Sleep from Baseline to Post-intervention and 4 weeks post-intervention	Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).	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.

Trial Locations

Locations (1)

Florida State University College of Nursing; 🇺🇸 Tallahassee, Florida, United States