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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06988501
Enrollment
110
Registered
2025-05-25
Start date
2024-07-02
Completion date
2025-12-31
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, High

Keywords

goal setting

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.

Interventions

BEHAVIORALGoal 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.

OTHERNutrition education

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

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diet qualityFrom enrollment to the end of treatment at 12 weeksDiet quality is measured by the DASH Score that includes eight dietary components to reflect the adherence to the DASH dietary pattern.

Secondary

MeasureTime frameDescription
Body WeightFrom enrollment to the end of treatment at 12 weeksBody weight will be measured by the bioelectrical impedance analysis.
Blood pressureFrom enrollment to the end of treatment at 12 weeksBlood pressure will be measured at baseline visit and the follow-up visit after the 12-week intervention. Blood pressure will be measured using calibrated electronic blood pressure monitor.

Other

MeasureTime frameDescription
Sleep QualityFrom enrollment to the end of treatment at 12 weeksSleep quality will be measured by the Pittsburgh Sleep Quality Index
DepressionFrom enrollment to the end of treatment at 12 weeksDepressive status will be measured by the Patient Health Questionnaire-9
AnxietyFrom enrollment to the end of treatment at 12 weeksAnxiety status will be measured by the Generalized Anxiety Disorder-7.

Countries

China

Contacts

Primary ContactXuezhu Sun
hlm2020fw@163.com+86 10 88396188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026