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Recruiting NCT06988501

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

No phase Interventional Blood Pressure, High

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goal setting with mobile-based self-management tool, Nutrition education.
Who it may be relevant to
Registry conditions: Blood Pressure, High. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Behavioral 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.
  • Other Nutrition education
    The control group will receive nutrition education about blood pressure management by the dietitian

Primary outcome measures

  • Diet quality [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (2)
  • Blood pressure [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Body Weight [Time frame: From enrollment to the end of treatment at 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Hospital, National Center for Cardiovascular Diseases — Beijing

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 24944055

Identifiers

NCT: NCT06988501 · 2023-2167

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗