On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients (VIVIR-MEJOR)
2017년 5월 23일 업데이트: Universitat Jaume I
Design, Development And Validation Of A On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive And Risk For Diabetes Mellitus People With Overweight And Type I Obesity
Efficacy of an Internet-based self-guided intervention for promoting healthy habits and weight loss in hypertensive people with overweight and obesity: A Randomized Controlled Trial
연구 개요
상세 설명
The prevalence of overweight and obesity is on the rise worldwide with severe physical and psychosocial consequences.
Hypertension is one of the comorbidities associated with obesity.
Changes in lifestyles through eating behavior and physical activity level are the critical components in the prevention and treatment for hypertension and obesity.
Data from several studies indicate that the usual procedures to promote these healthy habits in health services are inadequate.
ICTs has been demonstrated as an effective tool for implementation of psychological interventions focused on this type of population.
This study aims to describe a totally self-applied online program (¨Vivir Mejor¨) to promote healthy lifestyles (eating behavior and physical activity) for obese participants with hypertension.
Participants (BMI=25-35) will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group "Vivir Mejor" and control group (treatment as usual).
"Vivir Mejor" program is composed by 9 modules aimed for promoting healthy eating habits and increase physical activity.
Modules will be sent via Internet periodically.
After 6 months, a follow-up testing phase and a tracking module will be set.
The outcomes variables will include anthropometric data, changes in eating behavior and physical performance and cardiovascular variables.
연구 유형
중재적
등록 (실제)
106
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Overweight or obese grade I (BMI> 25 and <35)
- Age between 18-65 years
- Being in clinical medical treatment for prevention of metabolic syndrome or Cardiac complications
- Having internet access.
Exclusion Criteria:
- No Internet access; Taking more than 3 antihypertensive drugs
- Have Diabetes diagnosis; Meet the DSM-IV-TR of Eating Disorder
- Submit a serious psychological disorder diagnosed (psychosis, bipolar disorder, major depressive disorder, substance abuse)
- Have a disability which prevents or hinders the exercise and physical activity
- Be receiving any treatment for weight loss in another center.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Lifestyle on-line intervention
The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.
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The self-applied on-line intervention will comprise a behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating habits and physical activity in participants (Themes: 1.motivation for change; 2. nutrition and physical activity education; 3. barriers to change, healthy eating principles and how to be active; 4. Influence of thoughts; 5. Emotional eating and self-control; 6. Problem solving; 7. Body image and assertiveness; 8. Relapse prevention)..The program will be established as follows: The first day the participant log in the website where can access the processing modules.
A web page was developed specially for this study.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in blood pressure levels at 6 and 12 months
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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(arterial brachial systolic and diastolic pressure, determined by Omron®; in millimeters of mercury)
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life variables with the Quality of life-QLI
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Quality of life-QLI (Mezzich, Cohen and Ruiperez 1999; Spanish version of Mezzich et al, 2000): It includes 10 items, with multiple-choice Likert response format, consisting of a scale of 1 to 10. Evaluates 10 areas: physical, psychological, self-care and independent functioning welfare, occupational functioning , interpersonal functioning, social-emotional support, community and support services, personal fulfillment, spiritual fulfillment, overall perception of quality of life.
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Food Intake style with Dutch Eating Behaviour Questionnaire
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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DEBQ- Dutch Eating Behavior Questionnaire (Van Strien et al, 1986).
Translated into Spanish by Baños, 2011): Evaluates styles posing contribute intake or attenuate the development of overweight.
It is composed of 33 items, with Likert scale of 5 points.
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Pyshical activity with the International Physical Activity Questionnaire - IPAQ - short
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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- International Physical Activity Questionnaire - IPAQ - short (Booth, 2000.):
Self-report of 7 items that collects information about PA and sedentary behavior of people in four areas: activity at work, when traveling, at home and during leisure time (leisure).
The IPAQ addresses the number of days and minutes for performing physical activities such as leisure-time occupations, locomotion and housework activities.
The score is derived from the number of days, hours and minutes employed therein (Carral & Perez, 2011).
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Self-efficacy with the Self-Efficacy Questionnaire General
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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GSES-12 Self-Efficacy Questionnaire General (Baessler & Schwarcer, 1996): Self-report scale consisting of 10 items with Likert scales of 4 points.
It was designed to assess the overall efficacy and evaluates the stable sense of personal competence to effectively manage a variety of stressful situations
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Regulation of behavior in physical exercise and eating habits with BREQ-2
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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BREQ-2 - Scale regulation of behavior in physical exercise and eating habits (Markland & Tobin, 2004.
Validated to the Spanish context by Moreno, Cervellò & Martinez Camacho, 2006): The original questionnaire was developed to measure external regulation, introjected, identified and intrinsic motivation.
The BREQ-2 scale consists of 19 items, compared with 15 of the original scale, measuring stages of the continuum of self-determination.
An adaptation of this scale also be conducted to assess motivation to change eating habits.
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Blood preasure
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Pressure Arterial brachial systolic and diastolic (determined by Omron®; in millimeters of mercury), Central systolic and diastolic blood pressure (measured by MOBIL-O-GRAPH®; augmentation index), speed of the pulse wave; Afectación By vascular arterial stiffness parameters: speed of the pulse wave (PWV) and analysis of the pulse wave, augmentation index and central arterial pressure (measured by oscillometric brachial (MOBIL-O-GRAPH®) and carotid distensibility ultrasound (ESAOTE®);
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Estimation Indirect fitness level / activity energy expenditure using portable accelerometer (Actigraph GT1M®)
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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To assess cardiorespiratory endurance test subjects performed the 6MWT (Test of 6-minute walk): cardiorespiratory functional test consists of measuring the maximum distance you can go walking a subject for 6 minutes.
In each participant the routes meters, average heart rate (MHR) during test development (monitored through digital heart rate monitor Polar 610si®) and heart rate recovery phase to post-minute effort was recorded (FCR1 );
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
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Body Mass Index
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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(Body Mass Index = kilograms / height 2(meters).
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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Satisfaction with treatment
기간: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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6-item scale with a 10-point Likert scale.
It evaluates the user's opinion about the program received in terms of satisfaction and usefulness.
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It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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간행물 및 유용한 링크
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 9월 1일
기본 완료 (실제)
2017년 1월 1일
연구 완료 (실제)
2017년 4월 1일
연구 등록 날짜
최초 제출
2015년 4월 22일
QC 기준을 충족하는 최초 제출
2015년 5월 12일
처음 게시됨 (추정)
2015년 5월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 23일
마지막으로 확인됨
2017년 5월 1일
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. .