- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04580264
Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients (LOREB)
Lifestyle Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Valencia
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Sagunt, Valencia, Spanien, 46520
- Enrique Rodilla Sala
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Eksperimentel gruppe
Alle deltagere får adgang til den samme webbaserede livsstilsintervention (motion og ernæringsundervisning)
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Eating Behaviour
Tidsramme: 3 months
|
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?").
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BMI
Tidsramme: 3 Month
|
Body Mass Index
|
3 Month
|
|
Physical activity
Tidsramme: 3 months
|
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.
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3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: JUAN FRANCISCO L PÁRRAGA, PhD, Cardenal Herrera University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UNIVERSITY CARDENAL HERRERA-27
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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