Clinical trial NCT04628533: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity and Overweight
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: University of Tennessee
First posted: 2020-11-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Weight from baseline to 2, 4, 6 and 12 months
timeFrame: 2 months, 4 months, 6 months, 12 months
Secondary outcomes:
measure: Process measures: Attendance by subjects at weekly online meetings
timeFrame: 2,4,6 months
measure: Process measures: Completion of weekly online treatment modules by subjects
timeFrame: 2, 4, 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Burlington
country: United States
facility: Behavioral Weight Management Program/Univ of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Jean R Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina
name: Delia Smith West, PhD
role: PRINCIPAL_INVESTIGATOR
References: