Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Castilla And Leon
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Salamanca、Castilla And Leon、スペイン、37003
- Primary Care Research Unit, The Alamedilla Health Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.
Exclusion Criteria:
- Personal history of atherosclerotic disease.
- Unable to do exercise or follow the Mediterranean diet.
- Institutionalized.
- Terminal illness.
- Mental disorders that limited the intervention compliance.
研究計画
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Control group
Individual counselling on lifestyles.
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Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
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実験的:Intervention group
Individual counselling on lifestyles and additional group counselling on lifestyles.
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Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed. Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment. |
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 |
---|---|---|
Adherence to the Mediterranean diet
時間枠:1 year
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Measurement by validated 14-point Mediterranean Diet Adherence Screener
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1 year
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Self-reported physical activity
時間枠:1 year
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Measurement by short version of the International Physical Activity Questionnaire
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1 year
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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 |
---|---|---|
Changes in physical activity
時間枠:1 year
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Measurement by Pedometer
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1 year
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Changes in dietary pattern
時間枠:1 year
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Measurement by semi-quantitative Food Frequency Questionnaire
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1 year
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Cardiovascular risk factors
時間枠:1 year
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Measurement by Framingham Risk Score
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1 year
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Body composition
時間枠:1 year
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Measurement by Bioelectrical Impedance Analyzer
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1 year
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Cardio-ankle vascular index (CAVI)
時間枠:1 year
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Measurement by Vasera® VS-2000 device
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1 year
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Brachial-ankle pulse wave velocity (ba-PWV)
時間枠:1 year
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Measurement by Vasera® VS-2000 device
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1 year
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Ankle-brachial index (ABI)
時間枠:1 year
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Measurement by Vasera® VS-2000 device
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1 year
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Health related quality of life
時間枠:1 year
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Measurement by Spanish version of the SF-12 questionnaire
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1 year
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Immediate verbal memory
時間枠:1 year
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Assessment by immediate recall of a list of 15 words, in three attempts
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1 year
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Delayed verbal memory
時間枠:1 year
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Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
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1 year
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Phonological fluency
時間枠:1 year
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Assessment by enumerating for one minute as many words as possible starting with different letters
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1 year
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Attention
時間枠:1 year
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Assessment by Trail Making Test A
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1 year
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Processing speed
時間枠:1 year
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Assessment by Trail Making Test B
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1 year
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Executive functions
時間枠:1 year
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Assessment by Trail Making Test B
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1 year
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Working memory
時間枠:1 year
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Assessment by WAIS Digit Span Backward test
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1 year
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Sustained attention
時間枠:1 year
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Assessment by Stroop test
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1 year
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Selective attention
時間枠:1 year
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Assessment by Stroop test
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1 year
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協力者と研究者
捜査官
- 主任研究者:Sara Mora Simón, PhD、Primary Care Research Unit, The Alamedilla Health Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
心血管危険因子の臨床試験
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Niguarda Hospital募集