Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity (IBI-HTA)

Cardenal Herrera University

Status: Completed

Conditions: Hypertension; Obesity

Treatments: Behavioral: Control group; Behavioral: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT04426877

UNIVERSITY CARDENAL HERRERA-85

Details and patient eligibility

About

This study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

Full description

Hypertension and obesity or overweight related, even other associated comorbidities, involve a worrying public health problem. The evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. In this way, Information and Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties to maintain regular exercise or healthy eating habits. ICTs also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. Therefore, this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

Enrollment: 135 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertension
• Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
• Aged between 18-75 years

Exclusion criteria

• Not having access to the Internet or lack of information about it.
• Treatment with more than 3 antihypertensive drugs.
• Meet the criteria of the DSM-IV-TR of a Food Disorder.
• Presenting some type of severe psychiatric disorder.
• Disability that prevents or hinders physical exercise.
• Receiving some treatment for weight loss.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups

Experimental group

Experimental group

Description:

The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.

Treatment:

Behavioral: Experimental group

Control Group

Experimental group

Description:

The control group will receive the same web-based lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.

Treatment:

Behavioral: Control group