Lifestyle On-line Intervention in Patients With Obesity and Hypertension

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official 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

Conditions
-----------------
Obesity, Hypertension

Intervention / Treatment
-----------------
* Other: Educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education). | Other: Educational intervention<br>* 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.<br>* Other names: ICT intervention;|
| No Intervention: Control<br>The control group will receive Hospital treatment as usual. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Body mass index | At three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure (BP) | Systolic and diastolic blood pressure | At three months | 
| Glucose metabolism | Levels of glucose (mg/dL) and insulin (mg/dL) | At three months | 
| Physical activity | Levels of physical activity (measured with accelerometers) | At three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internet, Exercise, Nutrition, Obesity, Hypertension