Clinical trial NCT04426877: Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity
Official title: Impact Of An Exercise And Nutritional Education Self-Applied Online Intervention On Body Composition And Blood Pressure On Hypertensive Adults With Overweight Or Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Obesity
Keywords: Hypertension
Obesity
Internet
Exercise
Nutrition
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: At three months
Secondary outcomes:
measure: Blood Pressure (BP)
timeFrame: At three months
measure: Physical activity
timeFrame: At three months
measure: Fall risk
timeFrame: At three months
Other outcomes:
Locations:
city: Sagunt
country: Spain
facility: Enrique Rodilla Sala
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO L PÁRRAGA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lison JF, Palomar G, Mensorio MS, Banos RM, Cebolla-Marti A, Botella C, Benavent-Caballer V, Rodilla E. Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial. J Med Internet Res. 2020 Apr 14;22(4):e14196. doi: 10.2196/14196.