Lifestyle On-line Intervention in Patients With Obesity and Hypertension

Not Applicable

Completed

• Conditions: Hypertension; Obesity
• Interventions: Other: Educational intervention

• Registration Number: NCT03396302
• Lead Sponsor: Cardenal Herrera University

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).

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-10
• Study Start: 2018-01-22
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Educational intervention	The experimental group will receive access to the web-based lifestyle intervention (exercise and nutritional education).

Primary Outcome Measures

Name	Time	Method
BMI	At three months	Body mass index

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (BP)	At three months	Systolic and diastolic blood pressure
Glucose metabolism	At three months	Levels of glucose (mg/dL) and insulin (mg/dL)
Physical activity	At three months	Levels of physical activity (measured with accelerometers)

Trial Locations

Locations (1)

JF Lisón; 🇪🇸 Alfara del Patriarca, Valencia, Spain