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Completed

NCT Number: NCT04571450

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Francisco Lisón Párraga

Valencia, 46006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reintervention

Behavioral

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.

Primary outcomes

  1. Blood Pressure (BP)

    Time frame: 3 months

    Systolic and diastolic blood pressure

Secondary outcomes

  1. BMI

    Time frame: 3 months

    Body Mass Index

  2. Physical activity

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study 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.

Acronym: IBI-HTA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2020
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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