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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04580264
Other study ID # UNIVERSITY CARDENAL HERRERA-27
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date April 19, 2021

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 19, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Spain Enrique Rodilla Sala Sagunt 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 Eating Behaviour will be measured with the DEBQ (Dutch Eating Behaviour Questionnaire). DEBQ evaluates eating behaviour that may contribute to or mitigate the development of overweight. It consists of 33 items, with a 5-point Likert scale, which 89 evaluate three eating styles. The Emotional Eating Scale has 13 items (e.g. "Do you have a desire to eat when you are angry?"), the External Eating Scale has 10 items (e.g. "Do you eat more than usual when you see others eating?"), and the Restrictive Eating Scale has 10 items (e.g. "Do you eat less deliberately so that you don't gain weight?"). 3 months
Secondary BMI Body Mass Index 3 Month
Secondary Physical activity Levels of physical activity (measured with Short-International Physical Activity questionnaire). This Questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. 3 months
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