Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients

Hypertension Clinical Trial

— IBI-HTA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571450
• Other study ID #: UNIVERSITY CARDENAL HERRERA-26
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: June 2021
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 7, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Reintervention
This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.

Locations

Country	Name	City	State
Spain	Juan Francisco Lisón Párraga	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Lisón JF, Palomar G, Mensorio MS, Baños RM, Cebolla-Martí 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 Tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure (BP)	Systolic and diastolic blood pressure	3 months
Secondary	BMI	Body Mass Index	3 months
Secondary	Physical activity	Levels of physical activity (measured with SHORT-IPAQ Questionnaire). This Questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.	3 months