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Completed

NCT Number: NCT06490575

Using Nonpharmacological Approaches in Hypertension Prevention and Management

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

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Justin Hall

Manhattan, Kansas, 66502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Participants in the intervention group attended four face-to-face workshops (one session per week). Each session took about 30 minutes and consisted of lectures with PowerPoint presentations, discussion, questions and answers, and the distribution of educational pamphlets and booklets.

Primary outcomes

  1. Demographic and lifestyle pre- and post-survey instrument

    Time frame: 6 weeks

    The survey includes items on knowledge, risk perceptions, assessment of response efficacy and self-efficacy, intention for behavior change, and lifestyle behaviors.

  2. ASA24 automated self-administered 24-hour food recall

    Time frame: 6 weeks

    This tool is based upon the validated Automated Multiple-Pass Method (AMPM) to collect dietary data using the 24-hour food recall.

Secondary outcomes

  1. 36-item quality of life

    Time frame: 6 weeks

    The SF-36 includes one multi-item scale that assesses four major components: general health, mental health, physical health, and social function.

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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