- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491293
Piloting Visual Chat in Internet Obesity Treatment (CHAT)
December 5, 2018 updated by: Jean R. Harvey, PhD, RD, University of Vermont
CHAT is an internet-based weight loss research program designed for women with overweight or obesity who want to lose weight through dietary change and increased physical activity.
Participants will be randomized into a group-based online program who meet via a text chat or a video chat.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overall goal of this project is to determine whether weight losses can be improved if visual chat and electronic smart scales are added to an established 6-month online weight loss program.
The primary aim is to assess weight change differences between subjects randomized to receive an Internet program alone (with text chat; INTERNET) vs. an Internet program with visual chat and electronic scales (VIDEO INTERNET).
A secondary aim is to evaluate differences in social support experienced by subjects in both conditions.
Overweight and obese adults (n=40) at two study sites (UVM and the University of South Carolina) will be randomly assigned to Internet (n=20) or Video Internet (n=20).
All participants will receive the same 24 week web-based group weight control program which features synchronous facilitated chats and online behavioral tools.
The only difference will be the delivery of the chat (text vs. visual) and the electronic smart scales given to the VIDEO INTERNET group.
Assessments will be conducted at 0, 2 and 6 months and will include measures of body weight, treatment engagement (e.g., attendance, self-monitoring, website utilization), social support and treatment satisfaction.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Vermont
-
Burlington, Vermont, United States, 05405
- Behavioral Weight Management Program/Univ of Vermont
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18 years old
- BMI between 25 and 55
- Free of medical problems that would preclude participation in a behavioral weight reduction program containing an exercise component
- Not currently pregnant or pregnant in the previous 6 months or breastfeeding
- Must have a computer at home or work with access to the Internet
- Only one member of a household is eligible to participate
- Must successfully complete a self-monitoring diary of foods consumed for 3 days
- must be willing to share access to self monitoring information collected via My Fitness Pal by friending the CHAT research team
- Not currently on medication that might affect weight loss
- Not enrolled in another weight loss program
Exclusion Criteria:
- BMI less than 25 or more than 55
- Lost 10 pounds or more in the last 6 months
- Had a heart attack or stroke in the past 6 months
- Ever had weight loss surgery
- Currently taking medications for weight loss
- Persons required by their doctor to follow a special diet (other than low fat)
- Plans to move from the area in the upcoming 9 months
- Schedules that make it likely someone would have difficulty attending the scheduled chat groups
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Behavioral Weight Loss + Text chat
Internet delivery of a behavioral weight control program via text in a group format facilitated by an experienced registered dietitian.
Participants will have access to study materials including behavioral weight loss lessons on the study's website.
Participants will weigh themselves daily and report their weight privately (data will only be accessible by research personnel) on the study website.
|
Participants will attend weekly one hour classes on line.
They will type their input and responses within the chat room.
They will record their calorie and fat intake daily and weigh themselves daily.
Interventionists will review the diaries weekly and provide feedback to reinforce or shape new behaviors and to identify high risk situations for problem solving.
|
Experimental: Behavioral Weight Loss + Video chat
Internet delivery of a behavioral weight control program via video in a group format facilitated by an experienced registered dietitian.
Participants will have access to study materials including behavioral weight loss lessons on the study's website.
Participants will be given smart scales to weigh daily, and weight will be transmitted to a secure website accessible only by research personnel.
|
Participants will attend weekly one hour classes on line.
They will have audio and video within the chat room, and will talk with their facilitator and classmates during their weekly meeting.
They will record their calorie and fat intake daily and weigh themselves daily.
Interventionists will review the diaries weekly and provide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss from baseline
Time Frame: baseline, 2 months, 6 months
|
The investigators will assess weight change differences between subjects randomized to receive an internet program alone with text chat vs. an internet program with visual chat and bodytrace smart scales.
Weight will be assessed at baseline, 2 months after intervention begins, and at the end of intervention using a calibrated digital scale (Tanita, WB800S) with subjects in street clothes, without shoes.
|
baseline, 2 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance at chat
Time Frame: 6 months
|
The group facilitator will record attendance at chats.
Attendance at chat will be compared by treatment arm.
Rate of attendance is calculated as number of meetings attended out of a total possible 24 meetings over the course of the study.
|
6 months
|
Self monitoring dietary intake
Time Frame: 6 months
|
Number of weekly journals submitted out of a possible 24 weeks total will give the investigators the rate of self monitoring.
Rates of self monitoring will be compared by treatment arm.
|
6 months
|
Self monitoring weight
Time Frame: 6 months
|
Number of daily weights submitted over the course of 24 weeks divided by the possible total of weights will give the rate of weight self-monitoring (7/week x 24 weeks = 168 possible weights).
The VIDEO arm will be provided with BodyTrace electronic scales that report weight to a secure database via cellular connectivity.
Subjects in the TEXT arm will report their weights to their facilitator using their own digital scale at home.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean Harvey, PhD RDN, University of Vermont
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2018
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
March 22, 2018
First Submitted That Met QC Criteria
March 28, 2018
First Posted (Actual)
April 9, 2018
Study Record Updates
Last Update Posted (Actual)
December 6, 2018
Last Update Submitted That Met QC Criteria
December 5, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0409
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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