Viewing Study NCT06490575



Ignite Creation Date: 2024-07-17 @ 11:46 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06490575
Status: COMPLETED
Last Update Posted: 2024-07-08
First Post: 2024-06-14

Brief Title: Using Nonpharmacological Approaches in Hypertension Prevention and Management
Sponsor: Kansas State University
Organization: Kansas State University

Study Overview

Official Title: Using Nonpharmacological Approaches in Hypertension Prevention and Management
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this randomized controlled trial is to test the effectiveness of a four-module nutrition education resource promoting nonpharmacological approaches to prevent and manage hypertension The main questions it aims to answer are

Does the educational intervention increase the knowledge of using nonpharmacological approaches in preventing and managing hypertension among participants
Does the educational intervention improve participants lifestyle behaviors to prevent and manage hypertension Researchers will compare a four-module educational intervention with a control group no educational information received until after the study to see if the educational intervention works to improve knowledge and healthy lifestyle behaviors in preventing and managing hypertension

Participants will

Attend a 30-minute workshop every week for 4 weeks or no workshop at all
Complete a survey on demographic information knowledge lifestyle behaviors and quality of life at baseline and end of the study
Complete a dietary 24-hour food recall at baseline two weeks into the study and at the end of the study
Monitor blood pressure levels two times a day for four weeks
Detailed Description: Study Design

This study is a randomized controlled trial with 30 participants randomly divided into control n15 and intervention n15 groups

Pre- and post-survey Assessment

All participants completed a comprehensive self-administered survey at baseline which included

Knowledge related to hypertension and its management
Lifestyle behaviors diet physical activity alcohol intake smoking status
Quality of life metrics
Constructs from the Protection Motivation Theory PMT such as response efficacy self-efficacy perceived vulnerability perceived severity and intention

Dietary Assessment

The Automated Self-Administered 24-hour Dietary Assessment Tool ASA24 was used to assess participants intake of fruits vegetables dietary sodium and dietary potassium at three points

Baseline
Mid-program two weeks into the intervention
Post-intervention

Intervention

The intervention group attended four weekly workshops each lasting 30 minutes The workshops were designed and led by a public health nutrition doctoral student and a nutrition expert Each session included

Presentations with PowerPoint slides and interactive activities
Group discussions
Questions and answers
Distribution of educational pamphlets and booklets

The educational sessions focused on

Increasing knowledge about hypertension prevention and management
Promoting nonpharmacological approaches to prevent and manage hypertension such as dietary changes and lifestyle modifications
Addressing PMT components to influence participants beliefs and intentions regarding their health behaviors

Control Group

Participants in the control group did not receive any educational or counseling sessions during the intervention period After the post-intervention survey they were provided with all the educational materials and a brief overview of the contents

Data Analysis

Data collected from the surveys and ASA24 dietary assessments were analyzed using the Statistical Package for the Social Sciences SPSS Analyses focused on comparing changes in knowledge lifestyle behaviors quality of life and dietary intake between the control and intervention groups

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None