Obesity and OverweightNCT04628533
Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program
A study testing Four Month Duration Online Behavioral Weight Loss Program and Six Month Duration Online Behavioral Weight Loss Program in people with Obesity and Overweight, run by University of Vermont at 2 sites in United States.
Trial summary
This online pilot weight loss study will explore the feasibility of recruiting individuals to an established online behavioral weight loss program of varying duration (4 months vs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Four Month Duration Online Behavioral Weight Loss Program and Six Month Duration Online Behavioral Weight Loss Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2020to Feb 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- BMI between 25-55
- free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- not currently on medication that might affect weight loss
- not currently pregnant or pregnant in the previous 6 months or currently breastfeeding
- not enrolled in another weight reduction program
Show all 13Show fewer
- must have a computer (at home or work) with access to the Internet and a video camera
- must have a smart phone (to allow use of step counting and dietary intake self-monitoring apps)
- Only one member of a household will be eligible to participate
- must successfully complete a self-monitoring diary of foods consumed for a week during screening for study eligibility
- demonstrate the ability to access the website successfully (practice chat)
- agree to be randomized to either group
- must be willing to share access to self-monitoring information collected via the app MyFitnessPal, and Fitbit.com weight data collected via the digital smart scale (scale will be provided)
Who cannot join
- have had a heart attack or a stroke in the past 6 months,
- have ever had weight loss surgery,
- have lost more than 10 pounds in the previous 6 months,
- are currently taking medications for weight loss,
- are required by their doctor to follow a special diet (other than a low fat diet)
- have plans to move from the area in the upcoming 12 months
- who have schedules that will make it likely that they will have difficulty attending the scheduled "chat" groups
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Behavioral Weight Management Program/Univ of Vermont
Burlington, Vermont, 05405
University of South Carolina
Columbia, South Carolina, 29208
About this study
This online pilot weight loss study will explore the feasibility of recruiting individuals to an established online behavioral weight loss program of varying duration (4 months vs. 6 months), We will compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention. Both groups will receive the same intervention; the only difference is the number of weeks the group will meet. Both groups will complete follow ups at 2, 4, 6, and 12 months (12 months after the study begins).
Read the detailed description
Obesity presents a vexing public health challenge. Effective behavioral weight control treatments are available, loss, and projections show these interventions could have a significant impact on overall population health if the interventions were more broadly available. Internet delivery of behavioral lifestyle interventions has potential for broad reach and is thus an attractive option, although average weight losses tend to be lower than in a comparable behavioral program delivered in-person. Nonetheless, internet-delivered group behavioral weight control programs which incorporate synchronous chat "group sessions" can produce an average of 5% weight loss, with almost a quarter of participants losing at least 10% of their body weight at 6-months, and thus offer weight losses which are clinically significant. Online programs are more cost effective than in-person delivery of the same program, but efforts to optimize the delivery of online programs to achieve the best weight outcomes balanced against delivery cost are in their infancy. The current feasibility study seeks to explore critical elements to allow testing of whether a moderate dose program (16 online weekly video chat sessions) can produce weight losses comparable to the higher dose (24 weekly video chat sessions) internet-delivered behavioral weight loss program which is the established standard which we have demonstrated effective in the past. This pilot study will provide proof-of-concept to determine whether the approach is promising and if it is feasible to conduct. The pilot will explore the feasibility of recruiting individuals to weight loss programs of varying duration (4 months vs. 6 months), refine our ability to deliver the 16-session program, compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention over the 12-month study period.
Up to 80 individuals will be randomized into an online behavioral weight loss program lasting 4 months or 6 months. Individuals will meet weekly for one hour in a synchronous chat session with an experienced behavioral weight control counselor. Participants will be followed over 12 months from study start.
- Conditions
- Obesity and Overweight
- Being tested
- Four Month Duration Online Behavioral Weight Loss Program, Six Month Duration Online Behavioral Weight Loss Program
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four Month Duration Online Behavioral Weight Loss ProgramBehavioural
Participants meet weekly on line with other group participants for 16 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.
Six Month Duration Online Behavioral Weight Loss ProgramBehavioural
Participants meet weekly on line with other group participants for 24 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.
| Study group | Role | What they receive |
|---|---|---|
| Four Month Duration | Experimental | Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 16 weeks in a well-established behavioral weight loss program. Receives: Behavioral: Four Month Duration Online Behavioral Weight Loss Program |
| Six Month Duration | Active comparator | Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 24 weeks in a well-established behavioral weight loss program. Receives: Behavioral: Six Month Duration Online Behavioral Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight from baseline to 2, 4, 6 and 12 months
Weight loss at each follow-up will be calculated as % kg lost from baseline.
Measured: 2 months, 4 months, 6 months, 12 months
Secondary outcomes (2)
Process measures: Attendance by subjects at weekly online meetings
The group facilitator will take attendance at weekly online class meetings. Attendance at on-line meetings will be calculated as % of meetings actually attended out of 16 or 24 meetings that were scheduled according to condition assignment
Measured: 2,4,6 months
Process measures: Completion of weekly online treatment modules by subjects
Completion of online treatment modules by each subject by condition will be calculated as % modules completed out of 16 or 24 modules scheduled according to condition assignment. Module completion is defined as viewing the module and completing the online activity questions associated with each respective module.
Measured: 2, 4, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study startJul 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: COVID-19. Recruitment never began.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, University of Tennessee
- Responsible party
- Principal investigator, Jean R. Harvey, PhD, RD, University of Vermont
- Investigators
- Jean R Harvey, PhD, Principal investigator, University of VermontDelia Smith West, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628533
- Sponsor's protocol ID
- CHRBSS #STUDY00000761
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program
- ClinicalTrials.gov ID
- NCT04628533
- Acronym / sponsor ID
- CHRBSS #STUDY00000761
- Conditions
- Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19. Recruitment never began.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of South Carolina, University of Tennessee
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 13 Nov 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.
This online pilot weight loss study will explore the feasibility of recruiting individuals to an established online behavioral weight loss program of varying duration (4 months vs. 6 months), We will compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention. Both groups will receive the same intervention; the only difference is the number of weeks the group will meet. Both groups will complete follow ups at 2, 4, 6, and 12 months (12 months after the study begins).
Detailed description
Obesity presents a vexing public health challenge. Effective behavioral weight control treatments are available, loss, and projections show these interventions could have a significant impact on overall population health if the interventions were more broadly available. Internet delivery of behavioral lifestyle interventions has potential for broad reach and is thus an attractive option, although average weight losses tend to be lower than in a comparable behavioral program delivered in-person. Nonetheless, internet-delivered group behavioral weight control programs which incorporate synchronous chat "group sessions" can produce an average of 5% weight loss, with almost a quarter of participants losing at least 10% of their body weight at 6-months, and thus offer weight losses which are clinically significant. Online programs are more cost effective than in-person delivery of the same program, but efforts to optimize the delivery of online programs to achieve the best weight outcomes balanced against delivery cost are in their infancy. The current feasibility study seeks to explore critical elements to allow testing of whether a moderate dose program (16 online weekly video chat sessions) can produce weight losses comparable to the higher dose (24 weekly video chat sessions) internet-delivered behavioral weight loss program which is the established standard which we have demonstrated effective in the past. This pilot study will provide proof-of-concept to determine whether the approach is promising and if it is feasible to conduct. The pilot will explore the feasibility of recruiting individuals to weight loss programs of varying duration (4 months vs. 6 months), refine our ability to deliver the 16-session program, compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention over the 12-month study period.
Up to 80 individuals will be randomized into an online behavioral weight loss program lasting 4 months or 6 months. Individuals will meet weekly for one hour in a synchronous chat session with an experienced behavioral weight control counselor. Participants will be followed over 12 months from study start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four Month Duration | Experimental | Behavioral: Four Month Duration Online Behavioral Weight Loss ProgramParticipants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 16 weeks in a well-established behavioral weight loss program. |
| Six Month Duration | Active comparator | Behavioral: Six Month Duration Online Behavioral Weight Loss ProgramParticipants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 24 weeks in a well-established behavioral weight loss program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- female
- BMI between 25-55
- free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- not currently on medication that might affect weight loss
- not currently pregnant or pregnant in the previous 6 months or currently breastfeeding
Key exclusion criteria (7 listed)
- have had a heart attack or a stroke in the past 6 months,
- have ever had weight loss surgery,
- have lost more than 10 pounds in the previous 6 months,
- are currently taking medications for weight loss,
- are required by their doctor to follow a special diet (other than a low fat diet)
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 |
|---|---|---|
| Four Month Duration Online Behavioral Weight Loss ProgramParticipants meet weekly on line with other group participants for 16 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails. | Behavioural | Four Month Duration |
| Six Month Duration Online Behavioral Weight Loss ProgramParticipants meet weekly on line with other group participants for 24 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails. | Behavioural | Six Month Duration |
Primary outcome
Change in Weight from baseline to 2, 4, 6 and 12 months
Time frame: 2 months, 4 months, 6 months, 12 months
Weight loss at each follow-up will be calculated as % kg lost from baseline.
2 secondary outcomes
Process measures: Attendance by subjects at weekly online meetings
Time frame: 2,4,6 months
Process measures: Completion of weekly online treatment modules by subjects
Time frame: 2, 4, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Jean R Harvey, PhD principal investigator
University of Vermont
Delia Smith West, PhD principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four Month Duration Online Behavioral Weight Loss Program and Six Month Duration Online Behavioral Weight Loss Program in people with Obesity and Overweight, run by University of Vermont at 2 sites 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 13 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Weight from baseline to 2, 4, 6 and 12 months (time frame: 2 months, 4 months, 6 months, 12 months). 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 13 Nov 2020.