- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Valencia
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Sagunt, Valencia, 스페인, 46520
- Enrique Rodilla Sala
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 실험군
모든 참가자는 동일한 웹 기반 라이프스타일 중재(운동 및 영양 교육)에 액세스할 수 있습니다.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Eating Behaviour
기간: 3 months
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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BMI
기간: 3 Month
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Body Mass Index
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3 Month
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Physical activity
기간: 3 months
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: JUAN FRANCISCO L PÁRRAGA, PhD, Cardenal Herrera University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .