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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Video Chat +Personalized Feedback

Video Chat + Basic Feedback

Discussion Board for Social Support +Basic Feedback

Discussion Board for Social Support+Personalized Feedback

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Video Chat +Personalized Feedback

Video Chat + Basic Feedback

Discussion Board for Social Support + Basic Feedback

Discussion Board for Social Support+Personalized Feedback

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight loss

Change in body weight from baseline calculated as kg lost

Change in body weight from baseline calculated as % of body weight lost

1 - [follow-up body weight/ baseline body weight] = % body weight change

Secondary Outcome Measures

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.

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.

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).

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

Full Information

NCT ID

NCT04514900

First Posted

July 20, 2020

Last Updated

April 27, 2021

Sponsor

University of South Carolina

Collaborators

University of Vermont, University of Tennessee

1. Study Identification

Unique Protocol Identification Number

NCT04514900

Brief Title

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

Acronym

iREACH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 23, 2020 (Actual)

Primary Completion Date

March 8, 2021 (Actual)

Study Completion Date

March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Carolina

Collaborators

University of Vermont, University of Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

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

Obesity

Keywords

weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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)

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Video Chat +Personalized Feedback

Arm Type

Active Comparator

Arm Description

Arm Title

Video Chat + Basic Feedback

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Discussion Board for Social Support + Basic Feedback

Arm Type

Active Comparator

Arm Description

Arm Title

Discussion Board for Social Support+Personalized Feedback

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Video Chat +Personalized Feedback

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Video Chat + Basic Feedback

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Discussion Board for Social Support +Basic Feedback

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Discussion Board for Social Support+Personalized Feedback

Intervention Description

Primary Outcome Measure Information:

Title

Weight loss

Description

Change in body weight from baseline calculated as kg lost

Time Frame

Baseline, 2 and 4 months

Title

Change in body weight from baseline calculated as % of body weight lost

Description

1 - [follow-up body weight/ baseline body weight] = % body weight change

Time Frame

2 and 4 months

Secondary Outcome Measure Information:

Title

Treatment Engagement: daily weighing

Description

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.

Time Frame

Weeks 1 to 16

Title

Treatment Engagement: weekly food journal submissions

Description

Time Frame

Weeks 1 to 16

Title

Treatment Engagement: completion of the 16 weekly interactive online modules

Description

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).

Time Frame

Weeks 1 to 16

Title

Treatment Engagement: Attendance at Video Chat condition

Description

Time Frame

Weeks 1 to 16

Other Pre-specified Outcome Measures:

Title

Supportive Accountability

Description

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.

Time Frame

2 months and 4 months

Title

Social Support

Description

All participants will be administered the Perceived Social Support Scale to determine whether perceptions of social support differ depending on which intervention participants receive.

Time Frame

baseline, 2 months and 4 months

Title

Cost-Effectiveness Analyses

Description

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.

Time Frame

Weeks 1 to 16

Title

Treatment Expectations

Description

All participants will be queried as to their expectations and preferences in treatment prior to intervention.using a measure designed for the current study

Time Frame

Baseline

Title

Treatment Satisfaction

Description

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.

Time Frame

through study completion, up to 24 weeks

Title

Self Regulation Questionnaire

Description

Participants self report on their self management behaviors

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Delia 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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