Using Nonpharmacological Approaches in Hypertension Prevention and Management

NCT06490575 | Completed

• 1 other identifier: 10334
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

High Blood Pressure; Hypertension

Keywords

educational intervention; nonpharmacological approach; dietary behaviors; lifestyle behaviors

Outcome Measures

Primary Outcomes (2)

• Demographic and lifestyle pre- and post-survey instrument

  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

  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 Outcomes (1)

• 36-item quality of life

  6 weeks

Study Arms (2)

Control

NO INTERVENTION

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

Nutrition Education

EXPERIMENTAL

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

Interventions

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.

Nutrition Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kansas State University: lead

Study Sites (1)

Justin Hall

Manhattan, Kansas, 66502, United States

Location

Related Publications (5)

• Chatzinikolaou A, Tzikas S, Lavdaniti M. Assessment of Quality of Life in Patients With Cardiovascular Disease Using the SF-36, MacNew, and EQ-5D-5L Questionnaires. Cureus. 2021 Sep 14;13(9):e17982. doi: 10.7759/cureus.17982. eCollection 2021 Sep.

  PMID: 34667665 RESULT

• Carey RM, Whelton PK. The 2017 American College of Cardiology/American Heart Association Hypertension Guideline: A Resource for Practicing Clinicians. Ann Intern Med. 2018 Mar 6;168(5):359-360. doi: 10.7326/M18-0025. Epub 2018 Jan 23. No abstract available.

  PMID: 29357396 RESULT

• Schapira MM, Fletcher KE, Hayes A, Eastwood D, Patterson L, Ertl K, Whittle J. The development and validation of the hypertension evaluation of lifestyle and management knowledge scale. J Clin Hypertens (Greenwich). 2012 Jul;14(7):461-6. doi: 10.1111/j.1751-7176.2012.00619.x. Epub 2012 Apr 9.

  PMID: 22747619 RESULT

• Tsao CW, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Beaton AZ, Boehme AK, Buxton AE, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Fugar S, Generoso G, Heard DG, Hiremath S, Ho JE, Kalani R, Kazi DS, Ko D, Levine DA, Liu J, Ma J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Virani SS, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Martin SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation. 2023 Feb 21;147(8):e93-e621. doi: 10.1161/CIR.0000000000001123. Epub 2023 Jan 25.

  PMID: 36695182 RESULT

• Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension Guideline. Ann Intern Med. 2018 Mar 6;168(5):351-358. doi: 10.7326/M17-3203. Epub 2018 Jan 23.

  PMID: 29357392 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tandalayo Kidd, PhD

  Kansas State University

  PRINCIPAL INVESTIGATOR

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: Professsor

Model Details: The educational intervention was a randomized controlled trial in which participants were randomly divided into control and intervention groups.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 8, 2024
• Study Start: December 18, 2020
• Primary Completion: June 20, 2022
• Study Completion: February 20, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)