Weight LossNCT04756973
The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software
A study testing Behavioral weight loss program in people with Weight Loss, run by East Carolina University at 1 site in United States.
Trial summary
The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Behavioral weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 25 Nov 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or older, at a BMI of 27 kg/m2 or greater, and available to attend weekly online groups
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.
Read the detailed description
Object: The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.
Method: The BWLP program utilized Webex video conferencing software to deliver a 12-week, interactive, small group, weekly weight loss intervention. Participants were randomized to a standard BWLP or a standard behavioral weight loss program augmented with self-compassion skills training (BWLP+SC).
- Conditions
- Weight Loss
- Being tested
- Behavioral weight loss program
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss programBehavioural
A 12 week small group weight loss program delivered via teleconference video technology
| Study group | Role | What they receive |
|---|---|---|
| Standard weight loss | Active comparator | A 12 week small group weight loss intervention delivered via video teleconference technology. Receives: Behavioral: Behavioral weight loss program |
| Standard weight loss plus self-compassion skills training | Experimental | A 12 week small group weight loss intervention delivered via video teleconference technology. Receives: Behavioral: Behavioral weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Weight in kilograms
Measured: 12 weeks
height
meters
Measured: baseline
Secondary outcomes (2)
Self-compassion
Change in self-compassion scale score from pre to post
Measured: 12 weeks
Eating Behaviors
Change in eating behaviors scale from pre to post
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jul 2020
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Carels, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756973
- Sponsor's protocol ID
- UMCIRB 20-001508
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software
- ClinicalTrials.gov ID
- NCT04756973
- Acronym / sponsor ID
- UMCIRB 20-001508
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 16 Feb 2021 (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.
The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.
Detailed description
Object: The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.
Method: The BWLP program utilized Webex video conferencing software to deliver a 12-week, interactive, small group, weekly weight loss intervention. Participants were randomized to a standard BWLP or a standard behavioral weight loss program augmented with self-compassion skills training (BWLP+SC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard weight loss | Active comparator | Behavioral: Behavioral weight loss programA 12 week small group weight loss intervention delivered via video teleconference technology. |
| Standard weight loss plus self-compassion skills training | Experimental | Behavioral: Behavioral weight loss programA 12 week small group weight loss intervention delivered via video teleconference technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 or older, at a BMI of 27 kg/m2 or greater, and available to attend weekly online groups
Key exclusion criteria (1 listed)
- -
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 programA 12 week small group weight loss program delivered via teleconference video technology | Behavioural | Standard weight loss, Standard weight loss plus self-compassion skills training |
Primary outcome
weight loss
Time frame: 12 weeks
Weight in kilograms
height
Time frame: baseline
meters
2 secondary outcomes
Self-compassion
Time frame: 12 weeks
Eating Behaviors
Time frame: 12 weeks
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 16 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Robert Carels principal investigator
East Carolina University
1 site 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 program in people with Weight Loss, run by East Carolina University at 1 site 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 1 inclusion and 1 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 16 Feb 2021.