An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes. (PREVAIL)
"An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes."
調査の概要
状態
条件
詳細な説明
Rationale: An estimated 400,000 individuals in the Netherlands are living with undiagnosed type 2 diabetes (T2D), in addition to 1.1 million diagnosed cases. Unhealthy lifestyle behaviours are a major contributing factor. Intensive lifestyle interventions and Continuous Glucose Monitoring (CGM) have demonstrated effectiveness in improving health behaviour and glycaemic control. Digital health technologies, including personalised digital interventions and virtual coaching enable continuous, scalable and context-specific support, thereby facilitating sustained behaviour change and improved self-management. Remote lifestyle interventions are therefore promising and may enhance self-management and glycaemic control, reduce medicine use and delay the development of comorbidities and diabetes-related complications. This study evaluates a remote, personalised lifestyle program combining online group sessions, peer support, CGM use, and a virtual AI lifestyle coach for individuals living with T2D.
Objective: The objective of this study is to evaluate the added value of CGM, biofeedback and a virtual AI lifestyle coach providing personalised, data-driven support within a first prototype of a remote lifestyle intervention for adults with T2D. Specifically, this pilot randomized controlled trial aims to assess the incremental effects of CGM, biofeedback and AI supported personalised coaching, informed by glucose data, demographics, behaviour, goals and preferences on health behaviours and glycaemic control over a 12-month period with two follow-up measurements.
Study design: This three-arm parallel-group randomized controlled trial includes:
- A lifestyle program consisting of online group sessions and a peer support community.
- The same lifestyle program supplemented with a virtual AI lifestyle coach.
- The AI-supported program with four times CGM use.
Study population: Adults (n=160) with T2D (HbA1c ≥53 mmol/mol) without glucose lowering medication (except Metformin), both men and women from all ethnic backgrounds.
Intervention: Participants complete an online baseline questionnaire and a brief in-app intake prior to randomization. All participants attend online group sessions and may engage with peers via the online community. The AI lifestyle coach uses the baseline data to have personalised coaching conversations with the participant throughout the intervention. In the third arm, real-time CGM data are additionally integrated into the AI-driven personalisation process.
Main study parameters/endpoints: The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include changes in physiological (e.g. body weight), clinical (e.g. time in range), behavioural (e.g. dietary intake), and psychological (e.g. quality of life) outcomes.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lotte G.P. Peters, MSc
- 電話番号：+31534891403
- メール：lotte.peters@utwente.nl
研究連絡先のバックアップ
- 名前：Anouk Middelweerd, Dr
- 電話番号：+31534897486
- メール：a.middelweerd@utwente.nl
研究場所
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Overijssel
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Enschede、Overijssel、オランダ、7500 AE
- University of Twente
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コンタクト：
- Lotte G.P. Peters, MSc
- 電話番号：+31534891403
- メール：lotte.peters@utwente.nl
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主任研究者：
- Lotte G.P. Peters, MSc
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age: ≥18 years
- HbA1c: ≥53 mmol/mol (7 - 12%)
- Signed informed consent form and willing to comply with the study procedures
- Persons who are naïve for participation in a lifestyle program for the past two years
- Being digitally competent
- Mastering the Dutch language
- Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)
Exclusion Criteria:
- Medication use: any other glucose-lowering medication than metformin
- Comorbidities or medical conditions requiring a special diet that conflicts with the study
- Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)
- Circumstances that lead to unreliable HbA1c values, such as blood donation
- Pregnant or lactating women
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：支持療法
- 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 |
|---|---|
|
アクティブコンパレータ：Arm 1
Lifestyle program (control group)
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Participants are asked to work on improving their lifestyle.
They have access to an online community throughout the study, where they can get in touch with other participants within their research-arm.
Participants are also asked to attend twelve online group sessions, during which a lifestyle coach will explain more about nutrition, physical activity, sleep, stress, social aspects, challenges and setbacks, and long-term maintenance.
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実験的：Arm 2
Lifestyle program + coach
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Idem to arm one, supplemented with a virtual AI lifestyle coach.
The AI lifestyle coach can process all the information about the participant that was provided at baseline.
This information is compiled into a participant profile, which the AI lifestyle coach uses to initiate personalised conversations with the participant.
During these conversations, the AI lifestyle coach supports the participant through a structured coaching cycle of three phases: preparation (reflecting on what matters and co-creating a personalised plan), coaching (day-to-day support to work on the plan), and evaluation (reviewing progress and adjusting or renewing the plan).
The coach draws on an evidence-based knowledge base of lifestyle interventions to recommend appropriate, evidence-informed actions.
The use of the AI lifestyle coach is an additional topic to the online group sessions.
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実験的：Arm 3
Lifestyle program + coach + CGM
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Idem to arm two, but participants are also asked to wear an CGM four times for two consecutive weeks.
The glucose values information collected by the CGM is used by the AI lifestyle coach to make conversations with the participant even more personalized.
The use of CGMs is an additional topic to the online group sessions.
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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 HbA1c levels
時間枠：From the beginning of the study to the end of the study at 12 months
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The main study parameter is the impact of the lifestyle program on blood glucose levels, as evaluated by changes in HbA1c levels at the beginning of the study and after 3, 6 and 12 months.
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From the beginning of the study to the end of the study at 12 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 body weight
時間枠：From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in medication use
時間枠：From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in waist and hip circumference
時間枠：From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in albumin-creatinine ratio
時間枠：From the beginning of the study to the end of the study (12 months)
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Urine sample
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From the beginning of the study to the end of the study (12 months)
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Change in blood pressure
時間枠：From the beginning of the study to the end of the study (12 months)
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Systolic and diastolic blood pressure
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From the beginning of the study to the end of the study (12 months)
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Change in habitual dietary intake assessed with the Nutri+ instrument
時間枠：From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
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Change in glycaemic regulation assessed with CGM and blood sample
時間枠：From the beginning of the study to the end of the study (12 months)
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From the beginning of the study to the end of the study (12 months)
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Study evaluation
時間枠：Once at the end of the study at 12 months
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Dutch System Usability Scale (SUS).
Ten questions on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).
Higher scores indicate greater overall usability of the system being studied.
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Once at the end of the study at 12 months
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Tailoring
時間枠：Once at the end of the study at 12 months
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Success in Tailoring (SIT) scale.
Eight items on a 5-point Likert-scale (1 = strongly disagree to 5 = strongly agree).
Higher scores indicate greater perceived individual tailoring of the information.
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Once at the end of the study at 12 months
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Change in quality of life
時間枠：At the start of the study and at the two follow-up measurements at 18 and 24 months
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Health-related quality of life (EQ-5D).
It assigns a score across five health dimensions, from "I have no problems..." to "I am unable to...".
The higher the score, the better the quality of life.
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At the start of the study and at the two follow-up measurements at 18 and 24 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Socio-demographic characteristics
時間枠：At baseline
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Socio-demographic characteristics obtained with the baseline questionnaire.
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At baseline
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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 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- NL011950 (その他の識別子：Central Committee on Research Involving Human Subjects)
個々の参加者データ (IPD) の計画
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