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

NCT ID: NCT06988501

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure, High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Goal setting with mobile-based self-management tool

Intervention Type BEHAVIORAL

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.

Control group

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

Group Type ACTIVE_COMPARATOR

Nutrition education

Intervention Type OTHER

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

Interventions

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Goal 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.

Intervention Type BEHAVIORAL

Nutrition education

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuezhu Sun

Role: CONTACT

+86 10 88396188

Facility Contacts

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Xuezhu Sun

Role: primary

+86 10 88396188

References

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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.

Reference Type BACKGROUND
PMID: 35819830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31353783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34123579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32477026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10028217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10431937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18268173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24944055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20645853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35706092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12493255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31865786 (View on PubMed)

Other Identifiers

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2023-2167

Identifier Type: -

Identifier Source: org_study_id

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