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Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program

Primary Purpose

Obesity and Overweight

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Four Month Duration Online Behavioral Weight Loss Program
Six Month Duration Online Behavioral Weight Loss Program
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity and Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • University of South Carolina
  • Behavioral Weight Management Program/Univ of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Four Month Duration

Six Month Duration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
November 2, 2020
Last Updated
November 12, 2020
Sponsor
University of Vermont
Collaborators
University of South Carolina, University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT04628533
Brief Title
Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program
Official Title
Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19. Recruitment never began.
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
University of South Carolina, University of Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Four Month Duration
Arm Type
Experimental
Arm Description
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.
Arm Title
Six Month Duration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Four Month Duration Online Behavioral Weight Loss Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Six Month Duration Online Behavioral Weight Loss Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight from baseline to 2, 4, 6 and 12 months
Description
Weight loss at each follow-up will be calculated as % kg lost from baseline.
Time Frame
2 months, 4 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Process measures: Attendance by subjects at weekly online meetings
Description
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
Time Frame
2,4,6 months
Title
Process measures: Completion of weekly online treatment modules by subjects
Description
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.
Time Frame
2, 4, 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean R Harvey, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Delia Smith West, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Facility Name
Behavioral Weight Management Program/Univ of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

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Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program

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