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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03491293
Other study ID # 18-0409
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2018
Est. completion date November 30, 2018

Study information

Verified date December 2018
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral Weight Loss + Text
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.
Behavioral Weight Loss + Video
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

Locations

Country Name City State
United States Behavioral Weight Management Program/Univ of Vermont Burlington Vermont
United States University of South Carolina Columbia South Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss from baseline 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 Attendance at chat 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
Secondary Self monitoring dietary intake 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
Secondary Self monitoring weight 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
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