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Rural Chronic Disease Risk Reduction

Primary Purpose

Chronic Disease, Risk Reduction

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Risk Reduction
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring chronic disease, health promotion, risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Florida State University College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

The participant in the control group receive usual care.

The participants in the intervention group received the chronic disease risk reduction intervention.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
October 31, 2022
Last Updated
August 21, 2023
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT05611580
Brief Title
Rural Chronic Disease Risk Reduction
Official Title
Reducing Chronic Disease Risk Among Rural Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Risk Reduction
Keywords
chronic disease, health promotion, risk reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The participant in the control group receive usual care.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The participants in the intervention group received the chronic disease risk reduction intervention.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Risk Reduction
Intervention Description
The intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions.
Primary Outcome Measure Information:
Title
Change in Produce and Vegetable Consumption from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Dietary Fat Intake from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Exercise from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Physical Activity from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Health Habits and Knowledge from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Secondary Outcome Measure Information:
Title
Change in Sleep from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Stress from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Social Support from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Social Support to Eat Better and Move More from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).
Title
Change in Well-being from Baseline to Post-intervention and 4 weeks post-intervention
Description
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.
Time Frame
Baseline, Post-intervention (six weeks from baseline) and 4 weeks post-intervention (10 weeks from baseline).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Florida State University College of Nursing
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306-4310
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Rural Chronic Disease Risk Reduction

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