رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT05231824 (ReLearn) لـ السمنة، فقدان الوزن هي نشط (التجنيد مغلق). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة دركسلUsing Artificial Intelligence to Optimize Delivery of Weight Loss Treatment (ReLearn)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT05231824 (ReLearn) هي دراسة تدخُّلية لـالسمنة، فقدان الوزن وهي نشط (التجنيد مغلق). بدأت في ١٩ شعبان ١٤٤٣ هـ مع خطة لتجنيد ٣٣٦ مشاركًا. يقودها جامعة دركسل، ومن المتوقع اكتمالها بحلول ١٢ شوال ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١ ربيع الأول ١٤٤٧ هـ.
الملخص
Project ReLearn is testing the efficacy and cost-effectiveness of an Artificial Intelligence system for optimizing weight loss coaching. Participants are randomized to a 1-year weekly gold standard behavioral weight loss remote (video) group treatment or the AI-optimized treatment, which is made up of a combination of remote group treatment, short video call and automated message. In the AI-optimized condition, the system monitors outcomes (via wireless scale, mobile phone app, and wristworn tracker) and, each week, assigns each participant the treatments they have responding to the best, within certain time constraints.
العنوان الرسمي
Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
الحالات الطبية
السمنةفقدان الوزنالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:- Berry M, Taylor L, Huang Z, Chwyl C, Kerrigan S, Forman E. Automated Messaging Delivered Alongside Behavioral Treatment for Weight Loss: Qualitative Study. JMIR Form Res. 2023 Nov 6;7:e50872. doi: 10.2196/50872.
- Forman EM, Berry MP, Butryn ML, Hagerman CJ, Huang Z, Juarascio AS, LaFata EM, Ontanon S, Tilford JM, Zhang F. Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. Contemp Clin Trials. 2023 Jan;124:107029. doi: 10.1016/j.cct.2022.107029. Epub 2022 Nov 23.
معرّفات دراسة أخرى
- ReLearn
- R01DK12564
NCT معرّف
تاريخ البدء (فعلي)
2022-03-22
آخر تحديث مُنشور
2025-08-24
تاريخ الاكتمال (المقدر)
2026-03-31
عدد المشاركين المخطط لهم
٣٣٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
نشط (التجنيد مغلق)
الكلمات الرئيسية
Obesity
Weight Loss
Behavioral treatment
Artificial intelligence
Weight Loss
Behavioral treatment
Artificial intelligence
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم العاملي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
مقارن نشطBWL-S 1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician. | Standard Behavioral Weight Loss Treatment Behavioral weight loss treatment is the current gold standard treatment for obesity. |
تجريبيةBWL-AI 1 year of remote weight loss treatment made up of a combination of (1) remote small group-based behavioral weight loss sessions, (2) 12-minute individual video calls, (2) automated text messages. An MS-level clinician will deliver the group treatment. Most video calls will be delivered by a paraprofessional coach, but some by an MS-level clinician. Each week the AI system will select one of the interventions for each participant based on which treatment the participant has responded to the best, within certain time constraints. | AI-OPTIMIZED Behavioral Weight Loss Treatment AI-optimized Behavioral Weight Loss Treatment will continuously vary intensity (automated text message, videoconference group, individual coaching call) and coach type (paraprofessional or MS-level expert) based on continuously-monitored participant digital data. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Weight change | Weight will be measured using the Fitbit Aria Air wireless scale, which is accurate to 0.2 kg. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) use an average of 5 consecutive daily weights for each timepoint, (4) remove errant weights (e.g., \>1 kg change in 1 day). | Baseline, 1-month, 6-month, and 12-month assessment |
Costs | All time spent training counselors, participants and supervising counselors, will be tracked by the project coordinator, as will time counselors spend delivering individual and group treatment. The web portal will track counselor time on the portal, e.g., reviewing food records and texting. While the basic time commitments are pre-set by condition, several factors will vary including participant no-shows, participant drop-outs, and counselor adherence to time limits. | Baseline, 1-month, 6-month, and 12-month assessment |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Physical Activity | Minutes of moderate to vigorous physical activity (MVPA) will be measured via Fitbit, a consumer-grade wrist-worn activity tracker which has superior compliance and close-to-equivalent accuracy as a research-grade accelerometer. Number of days meeting MVPA goal will be used by the AI system, with MVPA minutes as a secondary outcome. | Baseline, 1-month, 6-month, and 12-month assessment |
Calorie intake | Seven days of calorie intake as derived from the Fitbit app's food log will be used as a secondary outcome. Participants will already be tracking their consumption using the app because data are used by both the coaches (per standard treatment) and the AI system. | Baseline, 1-month, 6-month, and 12-month assessment |
Acceptability as Measured by Likert Self-report Scale | Participants will be asked to rate satisfaction with and perceived effectiveness of the program. Counselors will rate effectiveness and ease of use. | 6-month and 12-month assessment |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Individuals must be of overweight or obese BMI (27-50 kg/m)
- Individuals must be adults (aged 18-70)
- Able and willing to engage in the remote program
- Able to engage in physical activity (defined as walking two city blocks without stopping)
- Individuals must also provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
- Access and willingness to use an Apple or Android smartphone
- Satisfactory completion of all enrollment procedures
- Medical condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
- Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months
- Recently began or changed the dosage of medication that can cause significant change in weight
- History of bariatric surgery
- Weight loss of > 5% in the previous 3 months
جامعة دركسل44 تجارب سريرية نشطة للاستكشافالجهة المسؤولة عن الدراسة
Erica Schulte, المحقق الرئيسي, Professor of Psychological and Brain Sciences, Drexel University
لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
Pennsylvania
Drexel University Center for Weight, Eating and Lifestyle Science, Philadelphia, Pennsylvania, 19104, United States