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AzTrials

Blood Pressure, HighNCT06988501

Goal Setting and Mobile-based Self-management Tool to Improve Diet Quality of People With High Blood Pressure

A study testing Goal setting with mobile-based self-management tool and Nutrition education in people with Blood Pressure, High, run by China National Center for Cardiovascular Diseases at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

SMART goal setting is a patient-led method that can help improve execution and facilitate behavioral changes. Functions such as diet tracking, interaction, and feedback in smartphone application may help enhance patient compliance. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Blood Pressure, High
What is being tested?
Goal setting with mobile-based self-management tool and Nutrition education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteChina
Study dates
2 Jul 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20-70;
  • Hypertension diagnosis, or high blood pressure (SBP between 120-139 mmHg and/or DBP between 80-89 mmHg);
  • Eating an unhealthy diet (estimated DASH score < 6) ;
  • Owning a smartphone and able to operate it proficiently;
  • Sign the informed consent.

Who cannot join

  • Severe cardiovascular and respiratory diseases, such as acute myocardial infarction, tachyarrhythmia, pulmonary edema, and severe aortic stenosis;
  • Acute phase of cardiovascular and cerebrovascular diseases;
  • Uncontrolled blood pressure;
  • Diagnosed mental diseases or epilepsy;
  • Cardiac pacemaker implantation;
  • Allergic constitutions;
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  • Pregnant women or planning to become pregnant;
  • Individuals who have participated in other clinical studies within the past 3 months;
  • Refuse to sign the informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xuezhu Sun contact

+86 10 88396188

hlm2020fw@163.com

China1 site, 1 recruiting

  • Fuwai Hospital, National Center for Cardiovascular Diseases

    Beijing, Beijing Municipality, 100037

    Xuezhu Sun, +86 10 88396188, hlm2020fw@163.com

    Recruiting

Other trials in China

About this study

Official title: The Effect of Goal Setting With Mobile-based Self-management Tool on Improving Diet Quality of People With High Blood Pressure: a Randomized Controlled Trial

SMART goal setting is a patient-led method that can help improve execution and facilitate behavioral changes. Functions such as diet tracking, interaction, and feedback in smartphone application may help enhance patient compliance. This study aims to explore the nutrition intervention measures of SMART goal setting combined with smartphone applications for daily self-management on the effect of improving diet quality of people with high blood pressure.

Being tested
Goal setting with mobile-based self-management tool, Nutrition education
Keywords
goal setting
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal setting with mobile-based self-management toolBehavioural

    In addition to the nutrition education provided to both groups, the participants of the intervention group will work with the dietitian to make behavior-change goals based on SMART goal setting strategy. They will also have access to diet tracking function and weekly report on smart phone application. The dietitian will also meet with the participants virtually to track their progress and provide suggestions.

  • Nutrition educationOther

    The control group will receive nutrition education about blood pressure management by the dietitian

Study groups in NCT06988501
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group will receive nutrition education on blood pressure management. The dietitian will work with the participants to set individual SMART goals. The participants will have access to diet tracking function, weekly reports and monthly virtual meeting with dietitian.
Receives: Behavioral: Goal setting with mobile-based self-management tool
Control groupActive comparatorThe control group will receive nutrition education on blood pressure management.
Receives: Other: Nutrition education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diet quality

    Diet quality is measured by the DASH Score that includes eight dietary components to reflect the adherence to the DASH dietary pattern.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (2)

  1. Blood pressure

    Blood pressure will be measured at baseline visit and the follow-up visit after the 12-week intervention. Blood pressure will be measured using calibrated electronic blood pressure monitor.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Body Weight

    Body weight will be measured by the bioelectrical impedance analysis.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start2 Jul 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988501
Sponsor's protocol ID
2023-2167
Status last verified
Oct 2024
First submitted
16 May 2025
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kassavou A, Wang M, Mirzaei V, Shpendi S, Hasan R. The Association Between Smartphone App-Based Self-monitoring of Hypertension-Related Behaviors and Reductions in High Blood Pressure: Systematic Review and Meta-analysis. JMIR Mhealth Uhealth. 2022 Jul 12;10(7):e34767. doi: 10.2196/34767.

    PubMed 35819830

  • Villinger K, Wahl DR, Boeing H, Schupp HT, Renner B. The effectiveness of app-based mobile interventions on nutrition behaviours and nutrition-related health outcomes: A systematic review and meta-analysis. Obes Rev. 2019 Oct;20(10):1465-1484. doi: 10.1111/obr.12903. Epub 2019 Jul 28.

    PubMed 31353783

  • Limketkai BN, Mauldin K, Manitius N, Jalilian L, Salonen BR. The Age of Artificial Intelligence: Use of Digital Technology in Clinical Nutrition. Curr Surg Rep. 2021;9(7):20. doi: 10.1007/s40137-021-00297-3. Epub 2021 Jun 8.

    PubMed 34123579

  • White ND, Bautista V, Lenz T, Cosimano A. Using the SMART-EST Goals in Lifestyle Medicine Prescription. Am J Lifestyle Med. 2020 Feb 17;14(3):271-273. doi: 10.1177/1559827620905775. eCollection 2020 May-Jun.

    PubMed 32477026

  • Wing RR, Jeffery RW. Benefits of recruiting participants with friends and increasing social support for weight loss and maintenance. J Consult Clin Psychol. 1999 Feb;67(1):132-8. doi: 10.1037//0022-006x.67.1.132.

    PubMed 10028217

  • Boutelle KN, Kirschenbaum DS, Baker RC, Mitchell ME. How can obese weight controllers minimize weight gain during the high risk holiday season? By self-monitoring very consistently. Health Psychol. 1999 Jul;18(4):364-8. doi: 10.1037//0278-6133.18.4.364.

    PubMed 10431937

  • Mellen PB, Gao SK, Vitolins MZ, Goff DC Jr. Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004. Arch Intern Med. 2008 Feb 11;168(3):308-14. doi: 10.1001/archinternmed.2007.119.

    PubMed 18268173

  • Yu D, Zhang X, Xiang YB, Yang G, Li H, Gao YT, Zheng W, Shu XO. Adherence to dietary guidelines and mortality: a report from prospective cohort studies of 134,000 Chinese adults in urban Shanghai. Am J Clin Nutr. 2014 Aug;100(2):693-700. doi: 10.3945/ajcn.113.079194. Epub 2014 Jun 18.

    PubMed 24944055

  • Savica V, Bellinghieri G, Kopple JD. The effect of nutrition on blood pressure. Annu Rev Nutr. 2010 Aug 21;30:365-401. doi: 10.1146/annurev-nutr-010510-103954.

    PubMed 20645853

  • Wang A, Tian X, Zuo Y, Chen S, Zhang Y, Zhang X, Deng X, Xu Q, Wang P, Wu S, Zhou Y. Control of Blood Pressure and Risk of Cardiovascular Disease and Mortality in Elderly Chinese: A Real-World Prospective Cohort Study. Hypertension. 2022 Aug;79(8):1866-1875. doi: 10.1161/HYPERTENSIONAHA.122.19587. Epub 2022 Jun 15.

    PubMed 35706092

  • Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.

    PubMed 12493255

  • Fuchs FD, Whelton PK. High Blood Pressure and Cardiovascular Disease. Hypertension. 2020 Feb;75(2):285-292. doi: 10.1161/HYPERTENSIONAHA.119.14240. Epub 2019 Dec 23.

    PubMed 31865786

Questions about this trial

What is this clinical trial studying?

A study testing Goal setting with mobile-based self-management tool and Nutrition education in people with Blood Pressure, High, run by China National Center for Cardiovascular Diseases at 1 site in China.

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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xuezhu Sun (+86 10 88396188, hlm2020fw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diet quality (time frame: From enrollment to the end of treatment at 12 weeks). 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 NCT06988501, which also lists 12 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 25 May 2025.

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