Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients

NCT ID: NCT04580264

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-04-19

Brief Summary

This research will constitute a 3-year follow-up that includes a re-evaluation and re-intervention of overweight or obese adults suffering from hypertension, who already participated in a similar programme with the same objectives 3 years ago.

Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and physical activity levels.

Detailed Description

Hypertension incidence and overweight or obesity related, constitute a worrying public health problem nowadays. Evidence indicates that, despite the existence of several factors involved in their etiology, diet and physical activity play a particularly important role in the treatment and prevention of obesity and associated disorders.

However, interventions for the treatment of obesity encounter some environmental and personal barriers, specifically problems or deficits in motivation. These barriers sometimes make it difficult to implement intervention strategies. In this sense, there is an important agreement about the need to generate alternatives and strategies which promote intrinsic motivation, self-regulation and self-efficacy as fundamental variables which have a direct relationship with the adherence and success of obesity treatments.

To achieve this, Information and Communication Technologies (ICTs) are a very promising alternative, as they can provide personalised feedback and can be flexibly adapted to each user. In addition, ICTs also present other important advantages, especially their excellent cost-benefit ratio, and the possibility of increasing the efficiency of the interventions, since they allow to reach a greater number of users at a lower cost.

This research will constitute a 3-year follow-up that includes a re-evaluation and re-intervention of overweight or obese adults suffering from hypertension, who already participated in a similar programme with the same objectives 3 years ago.

Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and physical activity levels.

Conditions

Hypertension; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

All participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education)

Group Type: EXPERIMENTAL

REINTERVENTION

Intervention Type: BEHAVIORAL

This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.

Interventions

REINTERVENTION

This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Hypertension.
• Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2).
• Aged between 18-65 years.
• Being a participant of the program 3 years ago.

Exclusion Criteria

• Not having access to the Internet or lack of information about it.
• Treatment with more than 3 antihypertensive drugs.
• 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.
• Receiving some treatment for weight loss.

• 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

Professor of the Deparment of Biomedical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JUAN FRANCISCO L PÁRRAGA, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardenal Herrera University

Locations

Enrique Rodilla Sala

Sagunto, 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: BACKGROUND

PMID: 32286232 (View on PubMed)

Other Identifiers

UNIVERSITY CARDENAL HERRERA-27

Identifier Type: -

Identifier Source: org_study_id