High Blood PressureNCT06490575
Using Nonpharmacological Approaches in Hypertension Prevention and Management
A study testing Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults in people with High Blood Pressure and Hypertension, run by Kansas State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure, Hypertension
- What is being tested?
- Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
- currently residing in Riley County, Kansas
- a US citizen or a permanent resident
- proficient in English
Who cannot join
- younger than 18 years old
- neither a US citizen nor a permanent resident
- nonproficient in English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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.
- Conditions
- High Blood Pressure, Hypertension
- Being tested
- Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults
- Keywords
- educational intervention, nonpharmacological approach, dietary behaviors, lifestyle behaviors
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among AdultsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
36-item quality of life
The SF-36 includes one multi-item scale that assesses four major components: general health, mental health, physical health, and social function.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start18 Dec 2020
- Primary completion20 Jun 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The educational intervention was a randomized controlled trial in which participants were randomly divided into control and intervention groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tandalayo Kidd, Kansas State University
- Investigators
- Tandalayo Kidd, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490575
- Sponsor's protocol ID
- 10334
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are secured in a password-locked device. Only the researcher and the PI can access the research data due to confidentiality.
Publications
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.
PubMed 34667665Carey 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.
PubMed 29357396Schapira 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.
PubMed 22747619Tsao 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.
PubMed 36695182Carey 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.
PubMed 29357392
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Nonpharmacological Approaches in Hypertension Prevention and Management
- ClinicalTrials.gov ID
- NCT06490575
- Acronym / sponsor ID
- 10334
- Conditions
- High Blood Pressure, Hypertension
- Keywords
- educational intervention, nonpharmacological approach, dietary behaviors, lifestyle behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The educational intervention was a randomized controlled trial in which participants were randomly divided into control and intervention groups.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among AdultsParticipants in the intervention group attended four face-to-face educational workshops (one session per week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- currently residing in Riley County, Kansas
- a US citizen or a permanent resident
- proficient in English
Key exclusion criteria (3 listed)
- younger than 18 years old
- neither a US citizen nor a permanent resident
- nonproficient in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among AdultsParticipants 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. | Other | Nutrition Education |
Primary outcome
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.
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.
1 secondary outcome
36-item quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Results publication: PubMed 34667665Chatzinikolaou 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.
- Results publication: PubMed 29357396Carey 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.
- Results publication: PubMed 22747619Schapira 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.
- Results publication: PubMed 36695182Tsao 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.
- Results publication: PubMed 29357392Carey 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.
- Individual participant dataSharing planned: No. Data are secured in a password-locked device. Only the researcher and the PI can access the research data due to confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tandalayo Kidd, PhD principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults in people with High Blood Pressure and Hypertension, run by Kansas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and lifestyle pre- and post-survey instrument (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490575, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.