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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorChina National Center for Cardiovascular Diseases

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diet quality

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

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

Secondary outcomes

1

Blood pressure

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.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Body Weight

Body weight will be measured by the bioelectrical impedance analysis.

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

Other outcomes

1

Sleep Quality

Sleep quality will be measured by the Pittsburgh Sleep Quality Index

Time frame
From enrollment to the end of treatment at 12 weeks
2

Depression

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

Time frame
From enrollment to the end of treatment at 12 weeks
3

Anxiety

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

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

Sponsors and contacts

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