糖尿病予防プログラムを高齢者集団にもたらす (BRIDGE)
Over 24 million Americans are over 65 years and have prediabetes. Prediabetes can be addressed using a public health approach: among the 20% of participants in the Diabetes Prevention Program (DPP) who were ages 60 and over, the diet and physical activity intervention conferred a 71% risk reduction of diabetes after an average follow-up of 3 years. The population of older adults is projected to more than double from 52.5 million in 2019 to ~100 million by 2060, and if projections hold, about half (48.3%) will have prediabetes. The proposed hybrid effectiveness implementation type 1 design will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older adults (DPP arm) using a randomized, controlled trial design (n=230). The preliminary data suggests DPP-TOAT is a feasible and acceptable way to deliver the DPP to older adults, and this will be the first study to compare the effectiveness and implementation of two strategies (telehealth versus in-person) to deliver a tailored DPP for the unique needs of the growing population of older adults.
調査の概要
状態
条件
詳細な説明
Eligible patients will be recruited through electronic health records (Epic and MyChart) and randomized to the 12-month DPP-TOAT or the in-person DPP program. Primary effectiveness outcome will be 6-month weight loss and implementation outcome will be attendance. A pragmatic approach will be used in order to inform future studies conducted in community-based and rural settings. Findings will inform best practices in the delivery of an evidence-based intervention that could reach the 30+ million adults aged 65 and over with prediabetes.
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
-
-
New York
-
New York、New York、アメリカ、10016
- NYU Langone Health
-
-
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:
- Men and women aged 65 years and older
- Diagnosis of pre-diabetes (A1c between 5.7-6.4%, fasting glucose between 100-125 mg/dL, or oral glucose tolerance test between 140-199 mg/dL within past 12 months)
- BMI of greater than or equal to 30
- English-speaking
- Under the care of a Primary care provider (PCP) in the NYU Langone Health system
- Able to travel to NYU Langone for in-person evaluations
- Access to a telephone
- Informed consent
Exclusion Criteria:
- Prevalent diabetes or end-stage renal disease
- Prior participation in the Diabetes Prevention Program
- A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
- Taking FDA-approved weight loss medications
- PCP stating that patient should not participate
- Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
- Severe visual impairment that precludes completion of assessments and/or intervention
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：In-person Diabetes Prevention Program (DPP)
Participants randomized to the in-person DPP intervention for 12 months |
Diabetes Prevention Program (DPP) is composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions over 12 months in person approved by the Centers for Disease Control and Prevention (CDC) |
|
アクティブコンパレータ：DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)
Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months. |
Diabetes Prevention Program (DPP) Tailored for Older Adults and delivered via Telehealth (DPP-TOAT) will be composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions |
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 |
|---|---|---|
|
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
時間枠：Baseline visit, 6 months visit, 12 month visit
|
In-person outcome assessment visits at the New York University Langone research clinic to measure weight at baseline, 6, and 12 months among all randomized participants |
Baseline visit, 6 months visit, 12 month visit
|
|
Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP
時間枠：Baseline visit, 6 months visit, 12 month visit
|
In-person outcome assessment visits at New York University Langone research clinic to measure glycemia at baseline, 6, and 12 months among all randomized participants |
Baseline visit, 6 months visit, 12 month visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to the DPP-TOAT is greater than the in-person DPP
時間枠：Baseline visit, 6 months visit, 12 month visit
|
This will be measured by the number of group sessions completed by each participant. |
Baseline visit, 6 months visit, 12 month visit
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jeannette M Beasley, PhD, RDN、NYU Langone Health
- 主任研究者：Joshua Chodosh, MD, MHS、NYU Langone Health
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
本研究に関する用語
その他の研究ID番号
- 21-01039
- 1R01DK127916-01A1 (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?
IPD プランの説明
Data collected from this study include anthropometric and blood draw data that will be uploaded to the participants' electronic medical record and questionnaire data that will only be used for study-related purposes.
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
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。