Exploring Optimal Treatment Components for Contactless Online Group-based Behavioral Weight Loss Program

Obesity Clinical Trial

— iREACH  

Official title:

Exploring the Optimal Treatment Components for a Contactless Online Group-based Behavioral Weight Loss Program for the COVID 19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514900
• Other study ID #: Pro00101006
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: April 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Video Chat +Personalized Feedback
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 Feedback
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 Feedback
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 Feedback
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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	University of Tennessee, University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Supportive Accountability	All participants will be administered the Supportive Accountability Questionnaire to determine whether there is a difference in accountability experienced by participants depending on which intervention they receive.	2 months and 4 months
Other	Social Support	All participants will be administered the Perceived Social Support Scale to determine whether perceptions of social support differ depending on which intervention participants receive.	baseline, 2 months and 4 months
Other	Cost-Effectiveness Analyses	Actual counselor time spent in delivering group video chats and giving feedback will be tracked in order to quantify the relative costs of delivering behavioral weight control programs.	Weeks 1 to 16
Other	Treatment Expectations	All participants will be queried as to their expectations and preferences in treatment prior to intervention.using a measure designed for the current study	Baseline
Other	Treatment Satisfaction	Each month participants will be asked to complete a survey inquiring about the helpfulness of the treatment modules, skills building assignments, and satisfaction with their treatment experiences in the previous month. Response options will be a 5-point Likert scale with 1=not at all helpful/useful and 5=extremely helpful/useful on a measure that is developed for this study and tailored to the treatment elements provided.	through study completion, up to 24 weeks
Other	Self Regulation Questionnaire	Participants self report on their self management behaviors	baseline
Primary	Weight loss	Change in body weight from baseline calculated as kg lost	Baseline, 2 and 4 months
Primary	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	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.	Weeks 1 to 16
Secondary	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.	Weeks 1 to 16
Secondary	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).	Weeks 1 to 16
Secondary	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	Weeks 1 to 16