糖尿病と肥満の予防とプログラムのケアを改善するためのヘルスケア環境での実用的な研究 (MAINTAIN PRIME)
糖尿病と肥満の予防とケアを改善するためのヘルスケア環境での実用的な研究 MAINTAIN PRIME (ケアチームによる真の (世界) IMplEmentation の促進)。
Many people struggle not only to lose weight through changes in diet and physical activity, but also to maintain weight loss once they have achieved it. In a previous study, our team designed and deployed a weight maintenance intervention that was delivered through the patient portal of an electronic health record (EHR) and found that patients who tracked their weight, diet, and physical activity and also received coaching had better success with maintaining recent intentional weight loss than patients who tracked but did not receive coaching. The investigators propose to repeat the intervention in a new health care system and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a more sustainable model that will allow ongoing intervention delivery after the proposed study ends.
This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME lifestyle coaching intervention to a control tracking intervention.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Obesity is a major health problem in the United States and associated with increased risk of diabetes. While many behavioral interventions have led to successful short-term weight loss, very few programs focus on weight loss maintenance after intentional loss, and fewer still are applicable to routine health care settings. There is a great need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing health care teams. The investigators have developed and tested an innovative weight loss maintenance intervention - Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the electronic health record (EHR) to help patients maintain recent intentional weight loss and successful lifestyle strategies.
The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at the University of Pittsburgh and found that participants who received EHR tracking tools and personalized coaching had significantly lower weight regain at 24 months (primary outcome) than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly available health information technology (HIT) tools to track participant progress and support patients and their providers in ongoing efforts to maintain weight loss. The investigators used an EHR platform (Epic) employed by many health care systems nationwide and integrated many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with routine clinic workflow.
Despite the success of MAINTAIN-pc, two key questions about the practicality and sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted at other sites and (ii) whether coaching could be delivered leveraging existing staff resources rather than interventionists supported by a research grant. The investigators propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World) IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards to track patient populations) and team-based care models to deliver the intervention with minimal support from research staff. The investigators will measure costs to inform future sustainability, and study workflow and individual, clinical, and organizational attributes to determine facilitators and barriers to successful implementation. With assistance from an External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and clinical resources to aid further dissemination.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Utah
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Salt Lake City、Utah、アメリカ、84132
- University of Utah Health Sciences Center
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-
参加基準
適格基準
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 18-75
- BMI of ≥ 25 prior to this intended weight loss
- Have experienced and maintained an intentional weight loss of at least 5% of body weight in the past 24 months
- Plan to maintain a University of Utah Health relationship in one of the participating primary care practices
- Have or be willing to get an account with the Epic MyHealth patient portal embedded in the electronic health record (EHR)
Exclusion Criteria:
- Medical conditions that might cause unintended weight loss such as cancer or thyroid disease
- Provider's assessment that patient is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
- Bariatric surgery in the last 2 years, or planned during the next 3 years
- Current or planned pregnancy in the next 3 years
- Currently breastfeeding
- Perceived lack of basic computer or Internet skills.
- Unable to attend the orientation/baseline visit or comply with the protocol procedures
- Any other underlying reason or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the participant at undue risk.
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：ライフスタイルコーチング
|
Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback. |
|
アクティブコンパレータ：コントロールトラッキング
|
Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Body Weight at Baseline and 24 Months
時間枠：Baseline and 24 months
|
Baseline and 24 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
BMI at Baseline and 24 Months
時間枠：Baseline and 24 months
|
Baseline and 24 months
|
|
|
Physical Activity as Measured in Daily Steps at Baseline and 24 Months
時間枠：Baseline and 24 months
|
Baseline and 24 months
|
|
|
Daily Minutes of Physical Activity at Baseline and 24 Months
時間枠：Baseline and 24 months
|
Baseline and 24 months
|
|
|
Dietary Habits as Measured by Mediterranean Diet Scale Score at Baseline and 24 Months
時間枠：Baseline and 24 months
|
A Mediterranean diet scale total score is a metric used to measure how closely a person's eating habits adhere with traditional, health-promoting Mediterranean diets. This 14 point scale, scored from 0-13 with higher scores indicating greater adherence. |
Baseline and 24 months
|
|
Pain Intensity
時間枠：Baseline and 24 months
|
Pain intensity as measured from a single Patient-Reported Outcomes Measurement Information System (PROMIS) question asking participants to rate their average pain over the past 7 days on a numeric rating scale from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity, reported as mean (SD) at baseline and 24 months. |
Baseline and 24 months
|
|
Quality of Function as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire Scores at Baseline and 24 Months
時間枠：Baseline and 24 months
|
The PROMIS Physical Function (PF) scale evaluates a patient's ability to perform daily activities. It is graded on a standardized T-score metric ranging from 20 to 80, where 50 represents the average U.S. general population and every 10 points represent one standard deviation. Higher scores consistently indicate better physical function. |
Baseline and 24 months
|
|
Systolic Blood Pressure at Baseline and 24 Months
時間枠：Baseline and 24 months
|
Baseline and 24 months
|
協力者と研究者
協力者
協力者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- IRB_00132802
- 1R18DK123372-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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