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

NCT06988501 | Recruiting

• 1 other identifier: 2023-2167
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure, High

Keywords

goal setting

Outcome Measures

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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

• Blood pressure

  From enrollment to the end of treatment at 12 weeks

• Body Weight

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (3)

• Sleep Quality

  From enrollment to the end of treatment at 12 weeks

• Depression

  From enrollment to the end of treatment at 12 weeks

• Anxiety

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Nutrition education

Interventions

Goal setting with mobile-based self-management tool 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.

Intervention group

Nutrition education OTHER

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

Control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 35819830 BACKGROUND

• 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.

  PMID: 31353783 BACKGROUND

• 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.

  PMID: 34123579 BACKGROUND

• 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.

  PMID: 32477026 BACKGROUND

• 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.

  PMID: 10028217 BACKGROUND

• 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.

  PMID: 10431937 BACKGROUND

• 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.

  PMID: 18268173 BACKGROUND

• 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.

  PMID: 24944055 BACKGROUND

• 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.

  PMID: 20645853 BACKGROUND

• 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.

  PMID: 35706092 BACKGROUND

• 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.

  PMID: 12493255 BACKGROUND

• 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.

  PMID: 31865786 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Xuezhu Sun

CONTACT

+86 10 88396188; hlm2020fw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: July 2, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2024-10

Locations

CN (1)