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Behavioural Intervention
Digital Weight Loss Interventions for Obesity (iREACH Trial)
N/A
Recruiting
Led By Delia West, PhD
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No physical limitations that prevent walking at a moderate pace for at least 10 minutes without stopping
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at baseline and 2, 6 and 12 months
Awards & highlights
iREACH Trial Summary
This trial will use digital treatments to help rural people reduce obesity rates. The study will look at 3 "high touch" intervention components to see which produce the best weight loss. 616 people from across the US will be tested.
Who is the study for?
This trial is for adults living in non-urban US areas with a BMI of 25-55, who can walk moderately for at least 10 minutes. They must have internet access and not be in another weight loss program or have had significant weight changes recently. Pregnant individuals or those with certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests if 'high touch' digital components like group video sessions, personalized feedback, and coaching calls improve weight loss in rural populations. Participants will use an interactive digital program over 24 weeks to see which methods contribute most to weight control.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on lifestyle changes rather than medication, typical side effects associated with drugs are not expected. However, participants may experience the physical strain from increased activity or psychological stress from dietary changes.
iREACH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk at a moderate pace for 10 minutes without stopping.
iREACH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at baseline and 2, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline and 2, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in weight at 6 months
Secondary outcome measures
Change in weight at 12 months
Other outcome measures
Change in weight at 2 months
Cost
Days of dietary self-monitoring
+11 moreiREACH Trial Design
8Treatment groups
Experimental Treatment
Group I: Core+Pre-Scripted Feedback+Individual Coaching CallsExperimental Treatment3 Interventions
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.
Group II: Core+Pre-Scripted FeedbackExperimental Treatment2 Interventions
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.
Group III: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching CallsExperimental Treatment4 Interventions
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.
Group IV: Core+Facilitated Weekly Group Sessions+Pre-Scripted FeedbackExperimental Treatment3 Interventions
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.
Group V: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching CallsExperimental Treatment4 Interventions
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.
Group VI: Core+Facilitated Weekly Group Sessions+Counselor Crafted FeedbackExperimental Treatment3 Interventions
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.
Group VII: Core+ Counselor Crafted Feedback+Individual Coaching CallsExperimental Treatment3 Interventions
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.
Group VIII: Core+ Counselor Crafted FeedbackExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core
2017
Completed Early Phase 1
~1180
Find a Location
Who is running the clinical trial?
University of VirginiaOTHER
754 Previous Clinical Trials
1,244,457 Total Patients Enrolled
17 Trials studying Obesity
1,916 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,313,976 Total Patients Enrolled
446 Trials studying Obesity
588,322 Patients Enrolled for Obesity
University of VermontOTHER
268 Previous Clinical Trials
3,743,129 Total Patients Enrolled
16 Trials studying Obesity
2,757 Patients Enrolled for Obesity
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the application process for this clinical trial still active?
"The information posted to clinicaltrials.gov attests that this trial is currently seeking participants. It was initially launched on October 16th 2023 and saw its most recent update on November 6th 2023."
Answered by AI
What is the current participating cohort size of this research?
"Affirmative, the clinical trial portal indicates this study is actively recruiting participants. It initially appeared on October 16th 2023 and was last updated November 6th of the same year. This research demands a total of 616 individuals to be enrolled from one medical centre."
Answered by AI
Who else is applying?
What site did they apply to?
University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve tried every diet out there, weight watchers, physicians weight loss, Aikens , Nutrisystem even looked into surgery but insurance won’t pay for it.
PatientReceived 2+ prior treatments
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