बीटा
ट्रायल रडार AI
क्लिनिकल ट्रायल NCT05410353 (CHAMPS) के लिए वजन कम होना, अधिक वजन और मोटापा, स्वास्थ्य व्यवहार वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ

Choosing Healthy Activities and Lifestyle Management Through Portal Support (CHAMPS)

सक्रिय, भर्ती नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT05410353 (CHAMPS) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो वजन कम होना, अधिक वजन और मोटापा, स्वास्थ्य व्यवहार से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 24 फ़रवरी 2023 को हुई थी, और इसमें कुल 229 प्रतिभागियों के नामांकन की योजना है। टेनेसी विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 20 नवंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for different population groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group.

*The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).

विस्तृत विवरण
This project tests whether the adapted Look AHEAD Intensive Lifestyle Intervention (ILI) will result in significant weight loss when delivered through Health IT - EHR patient portal compared to a Comparison group (based on Look AHEAD DSE Comparison group). This project will be conducted in 2 stages: a formative assessment stage (Stage 1) and a clinical trial stage (Stage 2).

During Stage 1, we will modify the interactive technology-based Look AHEAD ILI that we already developed for the TARGIT study (Active Intervention group). We will also adapt the Look AHEAD Comparison condition (DSE group) for our Comparison condition. We will also optimize the protocol for acceptability in different populations and in a rural setting.

During Stage 2, we will randomly assign 250 participants to either the Comparison Group or the Active Intervention Group to address the primary aim of testing the hypothesis that a multicomponent, behavioral weight loss intervention delivered through Health IT - patient portal will lead to significantly greater weight loss 12 months after enrollment in the Active Intervention group compared with the Comparison group. Our Health IT-based intervention is potentially cost-effective and thus disseminable to any practice-based physician group with access to an EHR with a patient portal.

आधिकारिक शीर्षक

Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk

चिकित्सीय स्थितियाँ
वजन कम होनाअधिक वजन और मोटापास्वास्थ्य व्यवहार
अन्य अध्ययन आईडी
NCT नंबर
NCT05410353
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-02-24
अंतिम अद्यतन प्रकाशित
2025-11-20
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12-31
नामांकन (अनुमानित)
229
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
health information technology
electronic health record
patient portal
प्राथमिक उद्देश्य
निवारण (रोकथाम)
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
प्रतिभागी समूह/हाथहस्तक्षेप/इलाज
प्रयोगात्मकActive Intervention Group
Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to different population groups
Active Intervention Group
The 3 major intervention components are diet, physical activity, and the behavioral modification curriculum. Scheduled interactions are educational podcasts (a series of audiovisual, digital media files) paired with a follow-up phone counseling session with a trained behavioral interventionist. A patient portal message will be sent to participants when a new podcast is posted. Interactive sessions will be weekly (weeks 1-16), biweekly (weeks 17-24), and monthly (weeks 25-52). The goal for weight loss is ≥ 7% of initial weight over the course of 12 months. Participants will restrict caloric intake with the goal of 1,200-1,500 kcal/day for those weighing \< 114 kg and 1,500-1,800 kcal/day for those weighing ≥ 114 kg. The physical activity goal will be for participants to gradually increase to 175-200 minutes of moderate-intensity activity per week by the 24th week. Participants will also be asked to self-monitor their dietary intake and physical activity using the "Lose It!" app.
सक्रिय तुलना समूहComparison Group
Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support
तुलना समूह
All participants in the Comparison Group will receive a mandatory 13 contacts per year including 3 informational sessions on nutrition, physical activity and social support and 10 contacts via patient portal or email regarding intervention topics. The Look AHEAD Comparison Group was designed to be realistic, achievable, and an acceptable intervention that encouraged optimal study retention.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Relative percentage change in weight
This is calculated for each follow-up visit as ((weight at FU visit - baseline weight) / (baseline weight)) × 100%.
12 months
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Relationship of mutlitlevel determinants of health (screening tool) with weight change over time
How multilevel determinants of health, assessed via the Social Needs Screening Tool, relate to patient success with weight loss
12 months
Relationship of mutlilevel determinants of health (BRFSS) with weight change over time
How multilevel determinants of health, assessed via the Social Determinants of Health Questions Adapted from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 Questionnaire, relate to patient success with weight loss
12 months
Relationship of multilevel determinants of health (z codes) with weight change over time
How multilevel determinants of health, assessed using z codes for Social Determinants of Health constructs abstracted from the Electronic Health Record using ICD -10 codes, relate to patient success with weight loss
12 months
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
16 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
  1. are ≥ 16 years old
  2. are overweight or obese (BMI ≥ 25 kg/m2)
  3. have access to the Internet via the computer or use a cellphone with a data-plan access
  4. are patients at one of the participating practice sites
  5. are willing to accept a random assignment, and
  6. are from different population groups (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).

  1. coronary or cerebrovascular disease events or vascular procedures within the past 6 months
  2. certain medical conditions that put participants at high risk of adverse events or preclude exercising
  3. uncontrolled psychiatric disorders
  4. current substance abuse, including heavy alcohol use ≥ 5 drinks on the same occasion for ≥ 5 days in the past 30 days
  5. a history of amputation or bariatric surgery or are planning to have bariatric surgery within the next 12 months
  6. current weight loss medication use
  7. malignancy within the last 5 years (except skin cancer)
  8. plans to move out of the area during the next year
  9. current participation in another clinical trial
  10. pregnancy or breast feeding or are planning to become pregnant within the next 12 months, and
  11. instances judged by the investigators' and primary care providers' discretion.
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University of Tennessee Health Science Center / Department of Preventive Medicine, Memphis, Tennessee, 38105, United States