Clinical trial NCT04580264: Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients
Official title: Lifestyle Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Overweight and Obesity
Keywords: Hypertension
Obesity
Internet
Re-intervention
Eating Behaviour
Physical Activity
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Eating Behaviour
timeFrame: 3 months
Secondary outcomes:
measure: BMI
timeFrame: 3 Month
measure: Physical activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Sagunt
country: Spain
facility: Enrique Rodilla Sala
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO L PÁRRAGA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.