Clinical trial NCT06988501: Goal Setting and Mobile-based Self-management Tool to Improve Diet Quality of People With High Blood Pressure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure, High
Keywords: goal setting
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-05-25
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Diet quality
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Body Weight
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
measure: Sleep Quality
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Depression
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Anxiety
timeFrame: From enrollment to the end of treatment at 12 weeks
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases
state: Beijing
Study officials:
References:
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