MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA
調査の概要
詳細な説明
Background: Obesity increases the prevalence and severity of cardiovascular risk factors such as hypertension, diabetes, and metabolic syndrome. It is also a leading contributor to cancer and osteoarthritis. Obesity and overweight are highly prevalent among VHA patients: As with the general population, over two-thirds of VHA users are either overweight or obese. There is good evidence that intensive weight reduction programs can have a modest-but clinically significant-impact on weight. VHA has developed a comprehensive weight management program known as MOVE! to address obesity among its patients. MOVE! evaluations to date have demonstrated success in helping Veterans lose weight, but participation is low. In the investigators' preliminary work, the investigators found that the timing (daytime) and location (ZVAMC) of MOVE! activities were viewed by eligible patients as barriers to participation. In addition, previous research has often demonstrated significant rebound in weight at the end of formal program activities, which may be mitigated if there is a convenient place for ongoing weight monitoring and healthy activities with peers.
Objectives: The overall goal of the project is to increase participation in the ZVAMC MOVE! program by implementing an innovative community-based program known as MOVE OUT. MOVE OUT will incorporate the key elements of the proven MOVE! program (education, peer support, and planned physical activity), but in settings closer to the homes of eligible Zablocki patients. The investigators have the following objectives:
- To reduce the mean weight of high-risk overweight or obese Veterans who receive primary care at ZVAMC.
- To improve the physical activity and diet of high-risk overweight or obese Veterans who receive primary care at ZVAMC.
- To demonstrate that an innovative community-based program can increase the proportion of ZVAMC users who participate actively in a moderately intensive weight management program as recommended by the National Institutes of Health Consensus Conference on Obesity.
Methods: The investigators will use a cluster randomized trial design. The investigators will allocate groups of eligible Veterans from ZVAMC to either a MOVE OUT invitation or a standard MOVE! invitation. The investigators will use clinically gathered weight data to determine overall rates of weight loss in the randomly assigned Veterans. In addition, the investigators will recruit a sample of Veterans from each randomized group to participate in a study of the effectiveness of the weight management program to which they are assigned. The investigators will use established methods to assess changes in diet, exercise and attitude, as well as physiologic outcomes including weight, blood pressure, Hemoglobin A1c, and lipid values. The investigators will use qualitative methods to learn what aspects of the two programs are most effective.
Impact: The investigators will demonstrate that VHA can deliver effective weight management services in a community-based fashion. If this study finds that such a delivery approach leads to an increased number of at-risk Veterans participating in weight control programs, it will guide program design throughout VHA. Although weight management is particularly well suited to a disseminated delivery model, lessons learned from this research are likely to help VHA improve its ability to help patients self-manage a variety of chronic diseases.
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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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53295-1000
- Clement J. Zablocki VA Medical Center, Milwaukee, WI
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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:
- Visit to ZVAMC primary provider within 3 months
- BMI >= 30 OR BMI >= 25 and Hypertension or Diabetes Mellitus
- No scheduled appointment for a MOVE program clinic
- Age <= 75 years
- Live in targeted geographic region
Exclusion Criteria:
- None
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 |
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実験的:Arm 1: MOVE OUT
The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
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The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
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アクティブコンパレータ:Arm 2: MOVE!
As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder."
This reminder prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial.
The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
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As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder."
This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial.
The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
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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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Change in Weight (From Baseline)
時間枠:Measured at 12 and 24 months
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Weight as recorded in the medical record during a 6-month period around the follow-up point.
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Measured at 12 and 24 months
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協力者と研究者
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 (見積もり)
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 OUT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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Dana-Farber Cancer Institute引きこもった
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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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VA Office of Research and Development募集
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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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University of LincolnNottinghamshire Healthcare NHS Trust募集
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Barron Associates, Inc.Duke University; University of Virginia募集