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Completed

NCT Number: NCT03396302

Lifestyle On-line Intervention in Patients With Obesity and Hypertension

This study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. Participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. Assessment will include: body composition (BMI), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

Design: Randomized Controlled Trial.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JF Lisón

Alfara del Patriarca, Valencia, 46113, Spain

About this study

Healthy eating and regular exercise play an important role to maintain health while ageing. Nutritional education and exercise practice could be monitored by different means, such as Internet, face to face and/or through exercise diaries. Information and Communication Technologies (ICTs) could be a useful tool to promote health, and could be used to work on barriers, such as low motivation and difficulties to maintain exercise or diet. ICTs also have other important advantages, especially their good cost-benefit relationship and the possibility of increasing the efficiency of interventions, allowing them to reach a wider audience at a lower cost. This study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. Participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. Assessment will include: body composition (BMI), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Overweight or obesity (BMI= 25-35 kg/m2)
  • Hypertension

Exclusion criteria

  • Not having access to the Internet or lack of information about it.
  • Treatment with more than 3 antihypertensive drugs.
  • Diabetes Mellitus Diagnosis.
  • 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.
  • Be receiving some treatment for weight loss in another center.

Treatment and study plan

Educational Intervention

Other

The self-applied on-line intervention will comprise a three months behavioural intervention composed by 8 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits.

Other names: ICT intervention

Primary outcomes

  1. BMI

    Time frame: At three months

    Body mass index

Secondary outcomes

  1. Blood Pressure (BP)

    Time frame: At three months

    Systolic and diastolic blood pressure

  2. Glucose metabolism

    Time frame: At three months

    Levels of glucose (mg/dL) and insulin (mg/dL)

  3. Physical activity

    Time frame: At three months

    Levels of physical activity (measured with accelerometers)

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Impact of An Exercise and Nutritional Education Based Intervention Through New Technologies on Body Composition and Blood Pressure in Hypertensive People With Overweight and Obesity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2018
Registry last updated
Jul 5, 2019

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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