رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06105957 (iREACH) لـ زيادة الوزن والسمنة هي قيد التجنيد. 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 كارولاينا الجنوبيةOptimal Digital Weight Loss Treatment for Rural Individuals (iREACH)
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 NCT06105957 (iREACH) هي دراسة تدخُّلية لـزيادة الوزن والسمنة وهي قيد التجنيد. بدأت في ٢١ جمادى الآخرة ١٤٤٥ هـ مع خطة لتجنيد ٦١٦ مشاركًا. يقودها جامعة كارولاينا الجنوبية، ومن المتوقع اكتمالها بحلول ٣ شعبان ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٧ جمادى الأولى ١٤٤٧ هـ.
الملخص
Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited in rural areas. Digital interventions offer an attractive alternative for delivering lifestyle programs to rural populations. However, in-person behavioral obesity treatment programs achieve better weight losses than digital programs, likely because in-person programs typically include personnel-intensive "high touch" treatment components. Some studies indicate that having a human "behind the curtain" of a digital program through emailed feedback or with the addition of online group sessions can significantly increase weight loss. Therefore, the aims of this study are to increase the public health impact of digital obesity treatment for rural populations by simultaneously investigating 3 "high touch" intervention components. The investigators will conduct a highly efficient experiment with participants residing in non-urban areas recruited online from across the United States. Participants (N=616; 22% racial/ethnic minority; 40% male) will be randomized to: (1) weekly facilitated synchronous group video sessions (yes vs. no); (2) type of self-monitoring feedback received (counselor-crafted vs. pre-scripted); and (3) individual coaching calls (yes vs. no). These components will be layered onto our 24-week evidence-based, interactive digital weight loss program delivered to groups of eligible individuals. Based on the results of the experiment, The investigators will identify an optimized program in which each component (or combination of components) contributes meaningfully (at least 1.5 kg greater weight loss at 6-months) to enhanced weight loss. The investigators will also exploratory analyses of weight trajectories 6-months post-treatment (i.e., at 12-months) to elucidate extended impact of the specific components on weight control. Ultimately, this research will set the stage for confirming the most promising digital behavioral weight loss intervention that can be used without geographic borders to reduce obesity rates among rural residents and provide the evidence needed to establish best practice policies for broadly effective digital approaches to weight control.
العنوان الرسمي
Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment
الحالات الطبية
زيادة الوزن والسمنةالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:- Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
- Kiernan M, Moore SD, Schoffman DE, Lee K, King AC, Taylor CB, Kiernan NE, Perri MG. Social support for healthy behaviors: scale psychometrics and prediction of weight loss among women in a behavioral program. Obesity (Silver Spring). 2012 Apr;20(4):756-64. doi: 10.1038/oby.2011.293. Epub 2011 Oct 13.
- Kliemann N, Beeken RJ, Wardle J, Johnson F. Development and validation of the Self-Regulation of Eating Behaviour Questionnaire for adults. Int J Behav Nutr Phys Act. 2016 Aug 2;13:87. doi: 10.1186/s12966-016-0414-6.
- Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.
- Nezu AM, Nezu CM, Perri MG. Problem-solving therapy for depression: Theory, research and clinical guidelines. John Wiley & Sons, 1989.
- Procidano ME, Heller K. Measures of perceived social support from friends and from family: three validation studies. Am J Community Psychol. 1983 Feb;11(1):1-24. doi: 10.1007/BF00898416.
- Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
معرّفات دراسة أخرى
- iREACH
- Pro00123003
- 1R01DK135227-01 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2024-01-03
آخر تحديث مُنشور
2025-10-29
تاريخ الاكتمال (المقدر)
2027-12-31
عدد المشاركين المخطط لهم
٦١٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
behavioral weight control
weight management
online weight loss program
weight management
online weight loss program
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم العاملي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةCore+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Facilitated Weekly Group Sessions Participants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted. Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges. Individual Coaching Calls Participants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format. |
تجريبيةCore+Facilitated Weekly Group Sessions+Pre-Scripted Feedback Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Facilitated Weekly Group Sessions Participants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted. Pre-scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff. |
تجريبيةCore+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Facilitated Weekly Group Sessions Participants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted. Individual Coaching Calls Participants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format. Pre-scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff. |
تجريبيةCore+Facilitated Weekly Group Sessions+Counselor Crafted Feedback Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Facilitated Weekly Group Sessions Participants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted. Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges. |
تجريبيةCore+ Counselor Crafted Feedback+Individual Coaching Calls Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges. Individual Coaching Calls Participants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format. |
تجريبيةCore+ Counselor Crafted Feedback Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges. |
تجريبيةCore+Pre-Scripted Feedback+Individual Coaching Calls Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.
Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Individual Coaching Calls Participants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format. Pre-scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff. |
تجريبيةCore+Pre-Scripted Feedback Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.
Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement. | النواة The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously. Pre-scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in weight at 6 months | The difference in weight between the randomization weight and the 6 month weight. Weight values will be obtained by an electronic scale provided to participants which transmits the data to the study server. | 6 months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in weight at 12 months | The difference in weight between the randomization weight and the 12 month weight. Weight values will be obtained by an electronic scale provided to participants which transmits the data to the study server. | 12 months |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
have a body mass index [BMI] > 25-55 kg/m2;
- home address in a zip code classified as non-urban in the USDA Rural-Urban Commuting Area [RUCA] codes of 4-10);
- have no physical limitations that prevent walking at a moderate pace for at least 10 minutes without stopping;
- be able to provide informed consent;
- have access to a smartphone and a computer or tablet with a video camera and stable access to the Internet (at home or work or some other stable source of access);
- complete all screening and baseline questionnaires and activities.
- only one member of a household may participate concurrently.
- currently participating in another weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 10 pounds during the past 6-months;
- are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation;
- report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity (e.g., uncontrolled heart condition, dementia, bulimia nervosa or binge eating disorder, or other significant psychiatric problems);
- or report conditions that in the judgment of the one of the Principal Investigators (MPIs) would render them unlikely to be able to independently follow the intervention protocol for 6 months, including conditions which might comprise their ability to engage independently with the intervention website materials, provide self-monitoring information on a smartphone app, attend Zoom video group or individual sessions at the available times (if randomized to receive these treatment components), and complete online questionnaires.
جامعة كارولاينا الجنوبية303 تجارب سريرية نشطة للاستكشاف
جامعة فرجينيا297 تجارب سريرية نشطة للاستكشاف
جامعة فيرمونت54 تجارب سريرية نشطة للاستكشاف- 🏛️National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
الجهة المسؤولة عن الدراسة
Delia Smith West, المحقق الرئيسي, Professor, University of South Carolina
جهة اتصال مركزية للدراسة
جهة اتصال: Teace Markwalter, MPH, CHES, 434-297-5874, [email protected]
جهة اتصال: Janna Borden, MS, 803-777-3471, [email protected]
1 مواقع الدراسة في 1 بلدان
South Carolina
University of South Carolina, Columbia, South Carolina, 29208, United States
Teace Markwalter, MPH, CHES, جهة اتصال, 866-271-7217, [email protected]
Janna Borden, MS, جهة اتصال, 866-271-7217, [email protected]
قيد التجنيد