ObesityiREACHNCT04514900
Exploring Optimal Treatment Components for Contactless Online Group-based Behavioral Weight Loss Program
A study testing Video Chat +Personalized Feedback, Video Chat + Basic Feedback and Discussion Board for Social Support +Basic Feedback in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Video Chat +Personalized Feedback, Video Chat + Basic Feedback and Discussion Board for Social Support +Basic Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Video Chat +Personalized Feedback, Video Chat + Basic Feedback, Discussion Board for Social Support +Basic Feedback, Discussion Board for Social Support+Personalized Feedback
- Keywords
- weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Chat +Personalized FeedbackBehavioural
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.
Video Chat + Basic FeedbackBehavioural
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.
Discussion Board for Social Support +Basic FeedbackBehavioural
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.
Discussion Board for Social Support+Personalized FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video Chat +Personalized Feedback | Active comparator | Participants 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. Receives: Behavioral: Video Chat +Personalized Feedback |
| Video Chat + Basic Feedback | Active comparator | Participants 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. Receives: Behavioral: Video Chat + Basic Feedback |
| Discussion Board for Social Support + Basic Feedback | Active comparator | Participants 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. Receives: Behavioral: Discussion Board for Social Support +Basic Feedback |
| Discussion Board for Social Support+Personalized Feedback | Active comparator | Participants 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. Receives: Behavioral: Discussion Board for Social Support+Personalized Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Change in body weight from baseline calculated as kg lost
Measured: 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
Measured: 2 and 4 months
Secondary outcomes (4)
Treatment Engagement: daily weighing
Self-monitoring rates for daily weighing and will be calculated as the total number of days of weight submitted over the 4 month period divided by the total number of days of potential self-weighing.
Measured: Weeks 1 to 16
Treatment Engagement: weekly food journal submissions
Self-monitoring rates for daily dietary self monitoring will be calculated as the total number of weeks of digital food diaries submitted over the 4 month period divided by the total number of weeks of potential digital diary submissions.
Measured: Weeks 1 to 16
Treatment Engagement: completion of the 16 weekly interactive online modules
Percent of weekly module completion will be calculated as the total number of weeks of completed modules submitted over the 4 month period divided by 16 (the total number of modules available).
Measured: Weeks 1 to 16
Treatment Engagement: Attendance at Video Chat condition
Percent of weekly video chat attendance will be calculated as the total number of weeks each participant attended video chat over the 4 month period divided by 16 (the total number of video chats available).- Collected only for those randomized to a condition with video chat
Measured: Weeks 1 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start23 Sep 2020
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 2x2 randomized controlled pilot study will be conducted which randomly allocates 73 individuals with overweight or obesity to an online weight control program and varies whether they receive asynchronous social support (discussion board) vs synchronous plus asynchronous social support (weekly video chat + discussion board) and varies whether the type of feedback which they receive on their self-monitoring (detailed vs basic) in a factorial study. All participants will receive the core 16-week online interactive behavioral weight loss program (iREACH) and will be followed for 4 months with monthly surveys and weight ascertainment.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont, University of Tennessee
- Responsible party
- Principal investigator, Delia Smith West, University of South Carolina
- Investigators
- Delia West, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514900
- Sponsor's protocol ID
- Pro00101006
- Acronym
- iREACH
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic
- ClinicalTrials.gov ID
- NCT04514900
- Acronym / sponsor ID
- iREACH / Pro00101006
- Conditions
- Obesity
- Keywords
- weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Vermont, University of Tennessee
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A 2x2 randomized controlled pilot study will be conducted which randomly allocates 73 individuals with overweight or obesity to an online weight control program and varies whether they receive asynchronous social support (discussion board) vs synchronous plus asynchronous social support (weekly video chat + discussion board) and varies whether the type of feedback which they receive on their self-monitoring (detailed vs basic) in a factorial study. All participants will receive the core 16-week online interactive behavioral weight loss program (iREACH) and will be followed for 4 months with monthly surveys and weight ascertainment.
| Arm | Type | Receives |
|---|---|---|
| Video Chat +Personalized Feedback | Active comparator | Behavioral: Video Chat +Personalized FeedbackParticipants 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 comparator | Behavioral: Video Chat + Basic FeedbackParticipants 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 comparator | Behavioral: Discussion Board for Social Support +Basic FeedbackParticipants 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 comparator | Behavioral: Discussion Board for Social Support+Personalized FeedbackParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Chat +Personalized FeedbackParticipants 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. | Behavioural | Video Chat +Personalized Feedback |
| Video Chat + Basic FeedbackParticipants 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. | Behavioural | Video Chat + Basic Feedback |
| Discussion Board for Social Support +Basic FeedbackParticipants 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. | Behavioural | Discussion Board for Social Support + Basic Feedback |
| Discussion Board for Social Support+Personalized FeedbackParticipants 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. | Behavioural | Discussion Board for Social Support+Personalized Feedback |
Primary outcome
Weight loss
Time frame: Baseline, 2 and 4 months
Change in body weight from baseline calculated as kg lost
Change in body weight from baseline calculated as % of body weight lost
Time frame: 2 and 4 months
1 - [follow-up body weight/ baseline body weight] = % body weight change
4 secondary outcomes
Treatment Engagement: daily weighing
Time frame: Weeks 1 to 16
Treatment Engagement: weekly food journal submissions
Time frame: Weeks 1 to 16
Treatment Engagement: completion of the 16 weekly interactive online modules
Time frame: Weeks 1 to 16
Treatment Engagement: Attendance at Video Chat condition
Time frame: Weeks 1 to 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delia West, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Chat +Personalized Feedback, Video Chat + Basic Feedback and Discussion Board for Social Support +Basic Feedback in people with Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Baseline, 2 and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.