Lifestyle Online Intervention On EB and BMI On Obese Hypertensive Adults (LOIEB)
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| ClinicalTrials.gov Identifier: NCT04739033 |
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Recruitment Status :
Completed
First Posted : February 4, 2021
Last Update Posted : June 29, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension Obesity | Behavioral: VIVIR MEJOR EXPERIMENTAL | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 135 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Lifestyle Online Intervention On Eating Behaviour and Body Mass Index On Obese Hypertensive Adults |
| Actual Study Start Date : | February 3, 2021 |
| Actual Primary Completion Date : | June 3, 2021 |
| Actual Study Completion Date : | June 10, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental group
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. |
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. |
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Active Comparator: Control Group
The control group will receive the same webbased lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.
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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. |
- Eating Behaviour, as measured with the DEBQ (Dutch Eating Behaviour Questionnaire). [ Time Frame: 3 months ]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.
- BMI [ Time Frame: 3 months ]Body Mass Index
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739033
| Spain | |
| Juan Francisco Lisón Párraga | |
| Valencia, Spain, 46006 | |
| Principal Investigator: | JUAN FRANCISCO L PÁRRAGA | Cardenal Herrera University |
| Responsible Party: | Juan F. Lisón Párraga, Dr, Professor of the Deparment of Biomedical Sciences, Cardenal Herrera University |
| ClinicalTrials.gov Identifier: | NCT04739033 |
| Other Study ID Numbers: |
UCH-86 |
| First Posted: | February 4, 2021 Key Record Dates |
| Last Update Posted: | June 29, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hypertension Obesity Internet |
Exercise Nutrition Eating Behaviour |
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Hypertension Vascular Diseases Cardiovascular Diseases |