Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514900
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2020-07-20
Brief Title:
Exploring Optimal Treatment Components for Contactless Online Group-based Behavioral Weight Loss Program
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iREACH
Brief Summary:
The current pilot study will explore the optimal cost-effective treatment configuration for online group-based weight control by focusing on two aspects of our existing treatment program which have significant associated cost and determine which contribute meaningfully to weight loss outcomes Specifically we will explore whether adding synchronous group social support weekly group video chat sessions facilitated by a trained weight loss counselor to on demand asynchronous social support provided through the program discussion board significantly increases weight losses achieved We will also examine whether detailed feedback on dietary and physical activity self-monitoring records from a counselor enhances weight loss outcomes in comparison with basic feedback Finally we will examine the cost efficiency of the treatment constellations Further this pilot study will also explore the feasibility of recruiting participants nationally rather than just locally and the capture of data electronically including body weight measurements without any in-person contact
Detailed Description:
All participants will receive the same online group-based weight loss program a lifestyle intervention which we have demonstrated to be effective in the past The 16-session goal-driven behavioral weight control program offers weekly interactive modules that provide evidence-based health education on caloric balance and physical activity increases with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10 The intervention is based on social cognitive theory and uses a self-regulation approach to learning new lifestyle habits that can produce and maintain weight loss Participants in all study arms will be provided with the same calorie and physical activity goals and all participants will be asked to self-monitor their dietary intake and physical activity daily using an app on their smart phone They will also be asked to weigh themselves daily consistent with research indicating that daily weighing is associated with greater weight loss and participants will be provided with a Bluetooth-enabled smart scale that will communicate weight to the password-protected study website visible to only the participant and study staff The study website also provides the dynamic programmatic content real time graphic feedback from self-monitoring for each individual participant and a study group discussion board for asynchronous group interactions and social support The website includes the core aspects of the behavioral program and is to be provided to all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None