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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Diet quality [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (2)

• Blood pressure [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Body Weight [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, National Center for Cardiovascular Diseases — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT06988501 · 2023-2167

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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