NCT05611580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

October 31, 2022

Last Update Submit

July 1, 2025

Conditions

Keywords

chronic diseasehealth promotionrisk reduction

Outcome Measures

Primary Outcomes (1)

  • 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), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.

Secondary Outcomes (9)

  • Change in Sleep from Baseline to Post-intervention and 4 weeks post-intervention

    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

    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

    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

    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

    Baseline, Post-intervention (six weeks from baseline), 4 weeks post-intervention (10 weeks from baseline), and six months post-intervention.

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

The participant in the control group receive usual care.

Intervention

EXPERIMENTAL

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

Behavioral: Chronic Disease Risk Reduction

Interventions

The intervention involves education information about chronic diseases and way to reduce risk for developing chronic diseases and/or decrease worsening of existing conditions.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

  • not from a rural area
  • younger than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University College of Nursing

Tallahassee, Florida, 32306-4310, United States

Location

MeSH Terms

Conditions

Chronic DiseaseRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 10, 2022

Study Start

January 1, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

July 4, 2025

Record last verified: 2025-07

Locations