Rural Chronic Disease Risk Reduction

July 1, 2025 updated by: Laurie Abbott, Florida State University

Reducing Chronic Disease Risk Among Rural Adults

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

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tallahassee, Florida, United States, 32306-4310
        • Florida State University College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control
The participant in the control group receive usual care.
Experimental: Intervention
The participants in the intervention group received the chronic disease risk reduction intervention.
The intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions.

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.
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.

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.

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.
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.
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.
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.

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.
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..

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..
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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00003258

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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