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RecruitingNCT06988501Updated May 25, 2025

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

An interventional study of Goal setting with mobile-based self-management tool and Nutrition education in Blood Pressure, High, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Jul 2024, registered May 2025).
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Blood Pressure, High

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Keywords

  • goal setting
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 110 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Intervention group

    The 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.

    Behavioral: Goal setting with mobile-based self-management tool

  • Active comparator
    Control group

    The control group will receive nutrition education on blood pressure management.

    Other: Nutrition education

Interventions

  • BehavioralGoal setting with mobile-based self-management tool

    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.

  • OtherNutrition education

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  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.

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Body Weight

    Body weight will be measured by the bioelectrical impedance analysis.

    Time frame: From enrollment to the end of treatment at 12 weeks

Other outcomes

  1. Sleep Quality

    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Depression

    Depressive status will be measured by the Patient Health Questionnaire-9

    Time frame: From enrollment to the end of treatment at 12 weeks

  3. Anxiety

    Anxiety status will be measured by the Generalized Anxiety Disorder-7.

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital, National Center for Cardiovascular Diseases
    Beijing, Beijing 100037, China
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06988501
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
May 25, 2025
Start date
Jul 2, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 25, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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