Lifestyle Online Intervention On EB and BMI On Obese Hypertensive Adults

Obesity Clinical Trial

— LOIEB  

Official title:

Lifestyle Online Intervention On Eating Behaviour and Body Mass Index On Obese Hypertensive Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739033
• Other study ID #: UCH-86
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to analyze the effects of a online program focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, and eating behaviour.

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.

Therefore, this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, and eating behaviour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 10, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hypertension

• Overweight or obesity (25 = BMI = 35 kg/m2)

• Aged between 18-75 years

• Being a participant of the program 5 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.

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

Behavioral:
• VIVIR MEJOR EXPERIMENTAL
This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor. The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.

Locations

Country	Name	City	State
Spain	Juan Francisco Lisón Párraga	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Lisón JF, Palomar G, Mensorio MS, Baños RM, Cebolla-Martí 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Behaviour, as measured with the DEBQ (Dutch Eating Behaviour Questionnaire).	The Dutch Eating Behaviour Questionnaire has 33 items, 13 of which refer to the emotional eating scale (eg, 'Desire to eat when irritated') and 10 of which refer to the external (eg, 'Eating when you feel lonely') and restrictive (eg, 'Difficult to resist delicious food') scales. The items can be rated on a five-point Likert-type scale, with a score of 1 indicating 'never' and 5 indicating 'very often (range 33-165). The lower the scores are, the lower the problematic eating behaviours are.	3 months
Secondary	BMI	Body Mass Index	3 months