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

Primary Purpose

Hypertension, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
REINTERVENTION
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Obesity, Internet, Re-intervention, Eating Behaviour, Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Enrique Rodilla Sala

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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

Outcomes

Primary Outcome Measures

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?").

Secondary Outcome Measures

BMI
Body Mass Index
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.

Full Information

First Posted
October 2, 2020
Last Updated
June 27, 2021
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT04580264
Brief Title
Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients
Acronym
LOREB
Official Title
Lifestyle Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Overweight and Obesity
Keywords
Hypertension, Obesity, Internet, Re-intervention, Eating Behaviour, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
All participants will receive access to the same web-based lifestyle intervention (exercise and nutritional education)
Intervention Type
Behavioral
Intervention Name(s)
REINTERVENTION
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating Behaviour
Description
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?").
Time Frame
3 months
Secondary Outcome Measure Information:
Title
BMI
Description
Body Mass Index
Time Frame
3 Month
Title
Physical activity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUAN FRANCISCO L PÁRRAGA, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enrique Rodilla Sala
City
Sagunt
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32286232
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.
Results Reference
background

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

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