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Piloting Visual Chat in Internet Obesity Treatment (CHAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491293
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
University of South Carolina
University of Tennessee
Information provided by (Responsible Party):
Jean R. Harvey, PhD, RD, University of Vermont

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Behavioral Weight Loss + Text Behavioral: Behavioral Weight Loss + Video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Piloting Visual Chat in Internet Obesity Treatment
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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.
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.

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.
Behavioral: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491293


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
United States, Vermont
Behavioral Weight Management Program/Univ of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
University of South Carolina
University of Tennessee
Investigators
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Principal Investigator: Jean Harvey, PhD RDN University of Vermont
Principal Investigator: Delia West, PhD University of South Carolina

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Responsible Party: Jean R. Harvey, PhD, RD, Principal Investigator, NFS Chair, Associate Dean, College of Agriculture and Life Sciences, University of Vermont
ClinicalTrials.gov Identifier: NCT03491293    
Other Study ID Numbers: 18-0409
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean R. Harvey, PhD, RD, University of Vermont:
internet
behavioral weight loss
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms