On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients (VIVIR-MEJOR)
2017年5月23日 更新者：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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
106
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in blood pressure levels at 6 and 12 months
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life variables with the Quality of life-QLI
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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®)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年9月1日
一次修了 (実際)
2017年1月1日
研究の完了 (実際)
2017年4月1日
試験登録日
最初に提出
2015年4月22日
QC基準を満たした最初の提出物
2015年5月12日
最初の投稿 (見積もり)
2015年5月15日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月25日
QC基準を満たした最後の更新が送信されました
2017年5月23日
最終確認日
2017年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Lifestyle on-line interventionの臨床試験
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