Exploring Optimal Treatment Components for Contactless Online Group-based Behavioral Weight Loss Program
iREACH
Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic
1 other identifier
interventional
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Sep 2020
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 17, 2020
CompletedStudy Start
First participant enrolled
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2021
CompletedApril 30, 2021
April 1, 2021
6 months
July 20, 2020
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight loss
Change in body weight from baseline calculated as kg lost
Baseline, 2 and 4 months
Change in body weight from baseline calculated as % of body weight lost
1 - \[follow-up body weight/ baseline body weight\] = % body weight change
2 and 4 months
Secondary Outcomes (4)
Treatment Engagement: daily weighing
Weeks 1 to 16
Treatment Engagement: weekly food journal submissions
Weeks 1 to 16
Treatment Engagement: completion of the 16 weekly interactive online modules
Weeks 1 to 16
Treatment Engagement: Attendance at Video Chat condition
Weeks 1 to 16
Other Outcomes (6)
Supportive Accountability
2 months and 4 months
Social Support
baseline, 2 months and 4 months
Cost-Effectiveness Analyses
Weeks 1 to 16
- +3 more other outcomes
Study Arms (4)
Video Chat +Personalized Feedback
ACTIVE COMPARATORParticipants meet as a group in weekly online video chats facilitated by an experienced behavioral weight control counselor. Participants have access to a website containing interactive weekly modules pertaining to weight loss skills as well as a discussion board where they may interact with other participants in addition to class meetings. They are asked to self-monitor food and beverage intake in a digital food diary (on a smartphone app) and will receive weekly detailed, personalized feedback on self-monitoring. Participants will be asked to weigh daily on a digital scale, which will be provided.
Video Chat + Basic Feedback
ACTIVE COMPARATORParticipants meet as a group in weekly online video chats facilitated by an experienced behavioral weight control counselor. Participants have access to a website containing interactive weekly modules pertaining to weight loss skills as well as a discussion board where they may interact with other participants in addition to class meetings. They are asked to self-monitor food and beverage intake in a digital food diary (on a smartphone app) and will receive basic feedback weekly on self-monitoring. Participants will be asked to weigh daily on a digital scale, which will be provided.
Discussion Board for Social Support + Basic Feedback
ACTIVE COMPARATORParticipants will access a website containing 16 interactive weekly modules pertaining to weight loss skills, as well as a discussion board on which they are encouraged through prompts and posts to interact with other participants for social support. They are asked to self-monitor food and beverage intake in a digital food diary (on a smartphone app) and will receive weekly basic feedback on self-monitoring. Participants will be asked to weigh daily on a digital scale, which will be provided.
Discussion Board for Social Support+Personalized Feedback
ACTIVE COMPARATORParticipants will access a website containing 16 interactive weekly modules pertaining to weight loss skills, as well as a discussion board on which they are encouraged through prompts and posts to interact with other participants for social support. They are asked to self-monitor food and beverage intake in a digital food diary (on a smartphone app) and will receive weekly detailed, personalized feedback on self-monitoring from a trained interventionist. Participants will be asked to weigh daily on a digital scale, which will be provided.
Interventions
Participants will receive an online 16-session, goal-driven behavioral weight control program via video chat and weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A group facilitator will monitor digital food diaries and provide detailed weekly feedback on diet and exercise.
Participants will receive an online 16-session, goal-driven behavioral weight control program via video chat and weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A group facilitator will monitor digital food diaries and provide basic weekly feedback on diet and exercise.
Participants will receive an online 16-session, goal-driven behavioral weight control program via weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. They also are provided with a study discussion board for social support from fellow participants. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A weight loss counselor will monitor digital food diaries and provide basic weekly feedback on diet and exercise.
Participants will receive an online 16-session, goal-driven behavioral weight control program via weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. They also are provided with a study discussion board for social support from fellow participants. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A weight loss counselor will monitor digital food diaries and provide personalized, detailed weekly feedback on diet and exercise.
Eligibility Criteria
You may qualify if:
- BMI between 27-55 kg/m2
- free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- must have a computer at home or work with video camera and access to the internet
- must have a smart phone
- only one member of a household may participate
- must successfully complete a self-monitoring diary of food and beverages consumed for 7 consecutive days
- must successfully set up the electronic scale (provided by the study at no cost) and transmit a body weight to study staff
- must agree to be randomized to any of the 4 groups
- must be willing to share access to their dietary and physical activity self-monitoring information collected via the Fitbit.com app/website and their weight data collected via linking the electronic smart scale with Fitbit.com
You may not qualify if:
- taking insulin
- currently on medication that might affect weight loss
- currently pregnant or pregnant in the previous 6 months
- currently breastfeeding
- enrolled in another weight reduction program
- have had a heart attack or stroke in the past 6 months
- ever had weight loss surgery
- have lost more than 10 pounds in the previous 6 months
- currently taking medications for weight loss
- required by their doctor to follow a special diet (other than a low fat diet)
- anyone who has a schedule that would make it difficult to attend scheduled "chat" groups, should they be randomized to receive that treatment component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Carolinalead
- University of Vermontcollaborator
- University of Tennesseecollaborator
Study Sites (1)
University of South Carolina
Columbia, South Carolina, 29208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delia West, PhD
University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Exercise Science
Study Record Dates
First Submitted
July 20, 2020
First Posted
August 17, 2020
Study Start
September 23, 2020
Primary Completion
March 8, 2021
Study Completion
March 8, 2021
Last Updated
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share