ObesityCHATNCT03491293
Piloting Visual Chat in Internet Obesity Treatment
A study testing Behavioral Weight Loss + Text and Behavioral Weight Loss + Video in people with Obesity, run by University of Vermont at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss + Text and Behavioral Weight Loss + Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Behavioral Weight Management Program/Univ of Vermont
Burlington, Vermont, 05405
University of South Carolina
Columbia, South Carolina, 29208
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss + Text, Behavioral Weight Loss + Video
- Keywords
- internet, behavioral weight loss, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss + TextBehavioural
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 + VideoBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss + Text chat | Active comparator | 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. Receives: Behavioral: Behavioral Weight Loss + Text |
| Behavioral Weight Loss + Video chat | Experimental | 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. Receives: Behavioral: Behavioral Weight Loss + Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 2 months, 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start6 Mar 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, University of Tennessee
- Responsible party
- Principal investigator, Jean R. Harvey, PhD, RD, University of Vermont
- Investigators
- Jean Harvey, PhD RDN, Principal investigator, University of VermontDelia West, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491293
- Sponsor's protocol ID
- 18-0409
- Acronym
- CHAT
- Status last verified
- Dec 2018
- First submitted
- 22 Mar 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Visual Chat in Internet Obesity Treatment
- ClinicalTrials.gov ID
- NCT03491293
- Acronym / sponsor ID
- CHAT / 18-0409
- Conditions
- Obesity
- Keywords
- internet, behavioral weight loss, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of South Carolina, University of Tennessee
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss + Text chat | Active comparator | Behavioral: Behavioral Weight Loss + TextInternet 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 Weight Loss + Video chat | Experimental | Behavioral: Behavioral Weight Loss + VideoInternet 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Weight Loss + TextParticipants 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. | Behavioural | Behavioral Weight Loss + Text chat |
| Behavioral Weight Loss + VideoParticipants 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 | Behavioural | Behavioral Weight Loss + Video chat |
Primary outcome
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.
3 secondary outcomes
Attendance at chat
Time frame: 6 months
Self monitoring dietary intake
Time frame: 6 months
Self monitoring weight
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Harvey, PhD RDN principal investigator
University of Vermont
Delia West, PhD principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss + Text and Behavioral Weight Loss + Video in people with Obesity, run by University of Vermont at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss from baseline (time frame: baseline, 2 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.