Lifestyle On-line Intervention in Patients With Obesity and Hypertension

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396302
• Other study ID #: CEU-UCH 2017-18
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: March 22, 2019

Study information

• Verified date: July 2019
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

Other:
• Educational intervention
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.

Locations

Country	Name	City	State
Spain	JF Lisón	Alfara del Patriarca	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Body mass index	At three months
Secondary	Blood Pressure (BP)	Systolic and diastolic blood pressure	At three months
Secondary	Glucose metabolism	Levels of glucose (mg/dL) and insulin (mg/dL)	At three months
Secondary	Physical activity	Levels of physical activity (measured with accelerometers)	At three months