Lifestyle On-line Intervention in Patients With Obesity and Hypertension

NCT ID: NCT03396302

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2019-03-22

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).

Conditions

Obesity; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Educational intervention

Intervention Type: 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.

Control

The control group will receive Hospital treatment as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

ICT intervention

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Head of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

JF Lisón

Alfara del Patriarca, Valencia, Spain

Countries

Spain

References

Lison JF, Palomar G, Mensorio MS, Banos RM, Cebolla-Marti A, Botella C, Benavent-Caballer V, Rodilla E. Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial. J Med Internet Res. 2020 Apr 14;22(4):e14196. doi: 10.2196/14196.

Reference Type: DERIVED

PMID: 32286232 (View on PubMed)

Other Identifiers

CEU-UCH 2017-18

Identifier Type: -

Identifier Source: org_study_id