Clinical trial NCT04571450: Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients
Official title: Effects On Blood Pressure And Body Composition Of A Self-Applied Online Re-Intervention Focused On Healthy Eating And Increased Physical Activity On Hypertensive Adults With Overweight Or Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Overweight and Obesity
Keywords: Hypertension
Obesity
Internet
Exercise
Nutrition
Reintervention
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. At the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. These patients will be allocated into one experimental group. Assessment will include: Blood Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.

Detailed description: Hypertension incidence and overweight or obesity related, constitute a worrying public health problem nowadays. In this sense, healthy eating and regular physical activity have demonstrated a relevant role maintaining health while ageing. Information and Communication Technologies (ICTs) have been shown as a useful way to promote health, improving motivation and overcoming difficulties to maintain a healthy lifestyle. ICTs also reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions.

This research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. At the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. These patients will be allocated into one experimental group. Assessment will include: Blood Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.

Eligibility criteria: Inclusion Criteria:

* Hypertension
* Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
* Aged between 18-65 years
* Have participated in the same program 3 years ago

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: Blood Pressure (BP)
timeFrame: 3 months
Secondary outcomes:
measure: BMI
timeFrame: 3 months
measure: Physical activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Juan Francisco Lisón Párraga
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO L Lisón 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.