An interventional study of Health behavior intervention in Hypertension, Health Behavior and Public Health, sponsored by Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Health services research
Hypertension is a major risk factor for cardiovascular disease, chronic kidney disease, and premature death worldwide. With an aging population and changes in dietary patterns and lifestyles, the prevalence of hypertension is rising globally, especially in developing countries. Hypertension is the most common chronic disease and a growing public health problem in China. A recent study estimated the prevalence of hypertension to be 28.56 % ± 10.44 %, ranging from 14.28% to 44.28% among the Chinese population aged over 15 years. The PRECEED-PROCEDE model provides a framework to help health planners and policymakers design effective health interventions based on evaluation and analysis of situations. This model has been used in different recent studies related to behavioral change. The study aims to examine the effectiveness of interventions for health behaviors in hypertensive patients based on the PRECEDE-PROCEED model.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 240 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.
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The intervention group, based on the three core elements of the PROCEED model (predisposing, enabling, and reinforcing factors), aims to influence the health behaviors of patients with hypertension.
Behavioral: Health behavior intervention
During the study, control participant will be provided with existing community health education on hypertension.
The program is a group-based intervention provided by a healthcare team consisting of researchers, cardiologists, family doctors, community healthcare workers, psychologists, and health education specialists. The intervention is structured around three modules-predisposing, enabling, and reinforcing factors-that provide a framework for educational interventions aimed at promoting healthy behaviors in hypertensive patients.
Health behavior
Health behaviors associated with hypertensive patients, including treatment adherence, physical activity. Treatment adherence will be measured by the Chinese version of Hill-Bone compliance to high blood pressure therapy scale (HBTS). Each item is rated on a 4-point Likert scale, ranging from 1 (All the Time) to 4 (None of the Time), with a higher score reflecting a better outcome. Physical activity will be measured by the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ-SF is a self-administered questionnaire, which is used to measure individuals' physical activity during the last seven days. Participants were required to report the frequency and duration that they engaged in each intensity activity. The total score is the summation of the duration and frequency of walking, moderate-, and vigorous-intensity activities, which was reported as the "metabolic equivalent of task-min per week. This instrument has been widely used and well validated.
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
systolic blood pressure
change in SBP between the intervention and control at 9 months
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
Delay discounting
Self-written computer program. Discount rates from the delay discounting task were calculated with hyperbolic discounting model of the form: V= A/(1+kD). A higher value of k value indicates a greater discount for delayed rewards.
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
Knowledge of hypertension
Self-compiled questionnaire. It consisted of 16 binary items. A score of 1 was given for each correct answer, and a score of 0 was given for incorrect and "don't know" replies for each question, with a higher score reflecting a better outcome.
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)
Reinforcing factors
The questionnaire of reinforcing factors will be designed based on the precede - proceed model. Each item is rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree), with a higher score reflecting a better outcome.
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)
Enabling factors
The questionnaire of enabling factors will be designed based on the precede - proceed model. Each item is rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree), with a higher score reflecting a better outcome.
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)
Self-efficacy
the Chinese version of the Perceived Health Competence Scale (PHCS). Each item is rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5(strongly agree), with a higher score reflecting a better outcome. This instrument has been widely used and well validated.
Time frame: 1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)
Plan to share: No
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