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NCT Number: NCT06988501

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

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.

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Key information

Conditions

Blood Pressure, High Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Xuezhu Sun

CONTACT

[email protected]

+86 10 88396188

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Nutrition education

Other

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

Primary outcomes

  1. Diet quality

    Time frame: From enrollment to the end of treatment at 12 weeks

    Diet quality is measured by the DASH Score that includes eight dietary components to reflect the adherence to the DASH dietary pattern.

Secondary outcomes

  1. Blood pressure

    Time frame: From enrollment to the end of treatment at 12 weeks

    Blood 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.

  2. Body Weight

    Time frame: From enrollment to the end of treatment at 12 weeks

    Body weight will be measured by the bioelectrical impedance analysis.

Other outcomes

  1. Sleep Quality

    Time frame: From enrollment to the end of treatment at 12 weeks

    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  2. Depression

    Time frame: From enrollment to the end of treatment at 12 weeks

    Depressive status will be measured by the Patient Health Questionnaire-9

  3. Anxiety

    Time frame: From enrollment to the end of treatment at 12 weeks

    Anxiety status will be measured by the Generalized Anxiety Disorder-7.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuezhu Sun

CONTACT

[email protected]

+86 10 88396188

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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