Using Nonpharmacological Approaches in Hypertension Prevention and Management

Kansas State University

Status: Completed

Conditions: Hypertension; High Blood Pressure

Treatments: Other: Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults

Study type: Interventional

Funder types: Other

Identifiers

NCT06490575

10334 (Other Identifier)

Details and patient eligibility

About

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

Full description

Study Design:

This study is a randomized controlled trial with 30 participants randomly divided into control (n=15) and intervention (n=15) 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years old or older
• currently residing in Riley County, Kansas
• a US citizen or a permanent resident
• proficient in English

Exclusion criteria

• younger than 18 years old
• neither a US citizen nor a permanent resident
• nonproficient in English

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in the control group received no educational or counseling sessions until the final post-survey questionnaires were administered.

Nutrition Education

Experimental group

Description:

Participants in the intervention group attended four face-to-face educational workshops (one session per week).

Treatment:

Other: Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults