Role of Apathy in the Effectiveness of Weight Loss Interventions
Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients
調査の概要
詳細な説明
Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients
Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program.
Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI>30, and apathy defined as AES score of > 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program.
Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study
Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs
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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Nebraska
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Omaha、Nebraska、アメリカ、68105-1873
- VA Medical Center, Omaha
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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:
- BMI >30
- Apathy score >40
Exclusion Criteria:
- History of cancer, except basal cell
- Cardiovascular event in last 6 months
- Renal failure
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
介入なし:1
standard nutrition counselling
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実験的:2
MOVE -weight loss intervention
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is a VA based multidesciplinary weight loss intervention
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実験的:3
MOVE plus medical crisis counselling
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is a VA based multidesciplinary weight loss intervention
group counselling sessions
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実験的:4
MOVE plus methylphenidate
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is a VA based multidesciplinary weight loss intervention
methyphenidate will be used to treat apathy dose 10mg bid
|
実験的:5
MOVE plus methyphenidate plus medical crisis counselling
|
is a VA based multidesciplinary weight loss intervention
group counselling sessions
methyphenidate will be used to treat apathy dose 10mg bid
|
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 |
---|---|---|
Apathy Evaluation Scale
時間枠:6 months
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Apathy Evaluation Scale (AES) measures apathy over the previous four weeks Scale range: 18 (minimum score)- 72 (Maximum score) Higher scores indicate higher apathy Better outcome would be reduction in the score
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6 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 |
---|---|---|
Change in Weight
時間枠:6 months
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value at 6 months minus value at baseline
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6 months
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協力者と研究者
捜査官
- 主任研究者:Cyrus DeSouza, MD、VA Medical Center, Omaha
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
MOVEの臨床試験
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Yale UniversityMayo Clinic; Duke University; National Evaluation System for health Technology Coordinating Center...積極的、募集していない
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VA Office of Research and Development積極的、募集していない
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Hospital Felix Bulnes完了人工呼吸の合併症 | 集中治療室症候群 | 集中治療室の後天的弱点 | 集中治療室 せん妄 | 集中治療神経障害チリ
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Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts, Boston完了乳がん | 乳がんサバイバー | フィットネストラッカーアメリカ
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Barron Associates, Inc.Duke University; University of Virginia募集
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VA Office of Research and Development完了
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Northwestern UniversityNorthwestern Medicine募集