Using Nonpharmacological Approaches in Hypertension Prevention and Management

June 28, 2024 updated by: Tandalayo Kidd, Kansas State University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

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

  • United States
    • Kansas
      • Manhattan, Kansas, United States, 66502
        • Justin Hall

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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
Participants in the control group received no educational or counseling sessions until the final post-survey questionnaires were administered.
Experimental: Nutrition Education
Participants in the intervention group attended four face-to-face educational workshops (one session per week).
Other: Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

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

Sponsor

Kansas State University

Investigators

  • Principal Investigator: Tandalayo Kidd, PhD, Kansas State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 18, 2020

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10334 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are secured in a password-locked device. Only the researcher and the PI can access the research data due to confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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