Biobehavioral Bases & Management of Metabolic Syndrome (CHARMS) (CHARMS)
2012年11月30日 更新者：Neil Schneiderman、University of Miami
Biobehavioral Bases & Management of Metabolic Syndrome
The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity.
The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures.
EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups.
It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups.
All participants will have baseline, 6-monthly and 1-year assessments.
This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).
調査の概要
詳細な説明
The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity.
The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures.
The project will compare the effects of Enhanced Care (EC) in 112 patients (80 completers) to Standard Care (SC) in 112 patients (80 completers) over a 12-month period.
Following 3 run-in sessions given to both SC and EC participants, eligible subjects randomized to SC will receive lifestyle modification advice as recommended management of the metabolic syndrome and this will be administered at the baseline and the 6 month assessment visits.
EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups.
It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups.
All participants will have baseline, 6-monthly and 1-year assessments.
This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).
Outcome variables will include measures of glycemic control/insulin resistance and/or dyslipidemia, oxidative stress, inflammation and overt manifestations of disease.
研究の種類
介入
入学 (実際)
112
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
30年～70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:
- Men and women
- Age 30-70 years
- Language: English or Spanish
- At least 3 features of the NCEP ATP-III metabolic syndrome
Exclusion Criteria:
- Diabetes
- Established CVD
- Uncontrolled hypertension (systolic BP >160 and diastolic BP >100 mm Hg)
- Established liver disease
- Renal insufficiency
- Psychiatric illness
- Chronic substance abuse within the past 5 years
- Chronic obstructive pulmonary disease or severe asthma.
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：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Lifestyle counseling
CHARMS Intervention Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention.
Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session.
The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly.
Each session was approximately 1-2 hrs.
At the beginning of each session anthropometric, physical activity and dietary data were collected.
Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began.
Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being.
Participants were given homework assignments to incorporate covered material into their daily lives.
Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
|
Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention.
Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session.
The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly.
Each session was approximately 1-2 hrs.
At the beginning of each session anthropometric, physical activity and dietary data were collected.
Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began.
Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being.
Participants were given homework assignments to incorporate covered material into their daily lives.
Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
|
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 |
|---|---|---|
|
Weight loss
時間枠：1 year
|
Weight will be checked during each intervention session with the goal of losing 7% of total body weight from the enrollment date.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measures of glycemic control/insulin resistance.
時間枠：1 year
|
Secondary outcomes measures will include glycemic control aka insulin resistance.
|
1 year
|
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。
スポンサー
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
2008年3月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2012年11月27日
QC基準を満たした最初の提出物
2012年11月30日
最初の投稿 (見積もり)
2012年12月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年12月4日
QC基準を満たした最後の更新が送信されました
2012年11月30日
最終確認日
2012年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- P01 HL 36588- Proj 2
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