Overweight and ObesityNCT05987306
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
A study testing Weight loss plus self-compassion in people with Overweight and Obesity, run by East Carolina University at 2 sites in United States.
Trial summary
The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Weight loss plus self-compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Sep 2023to 1 May 2024
- 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
- BMI ≥ 25, ≥ 18 years old
- Smartphone access
- WBIS score ≥ 4
Who cannot join
- Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any major active kidney, liver, cardio, or cerebrovascular disease,
- musculoskeletal problems that would prevent physical activity,
- current weight loss medication or weight loss program,
- history of bariatric surgery,
- pregnant or breastfeeding,
- eating disorder except binge eating disorder
Trial locations and contacts
2 sites in 1 country.
Abbie Metzler contact
United States2 sites, 2 recruiting
- Not yet recruiting
East Carolina University
Greenville, North Carolina, 27858
Robert Carels, PhD, 252-737-5070, carelsr14@ecu.edu
Abbie Metzler, BA, 2527375070, metzlera23@students.ecu.edu
- Recruiting
ECU, Dept of Psychology, 104 Rawl
Greenville, North Carolina, 27858
About this study
The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software.
Read the detailed description
The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12-week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. The weight loss approach will be modeled after the Diabetes Prevention Program and the approach utilized to reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each weekly session will utilize Webex videoconferencing software and last approximately 60-90 minutes.
- Conditions
- Overweight and Obesity
- Being tested
- Weight loss plus self-compassion
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss plus self-compassionBehavioural
A novel weight loss approach combining a standard weight loss based on the Diabetes Prevention Program and internalized weight bias intervention with self-compassion exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | a standard weight loss and internalized weight bias intervention with self-compassion exercises Receives: Behavioral: Weight loss plus self-compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (lbs)
Change in weight or percent body weight
Measured: 12 weeks
Weight Bias Internalization Scale
Change in internalized weight bias (range 1-7 with higher scores indicating greater internalized weight bias)
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 posted14 Aug 2023
- Study start24 Sep 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre and posttest design.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Alabama
- Responsible party
- Sponsor
- Investigators
- Robert Carels, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987306
- Sponsor's protocol ID
- UMCIRB 23-001492
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I am happy to make data available to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
- ClinicalTrials.gov ID
- NCT05987306
- Acronym / sponsor ID
- UMCIRB 23-001492
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- University of South Alabama
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 14 Aug 2023 (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 goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software.
Detailed description
The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12-week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. The weight loss approach will be modeled after the Diabetes Prevention Program and the approach utilized to reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each weekly session will utilize Webex videoconferencing software and last approximately 60-90 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre and posttest design.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Weight loss plus self-compassiona standard weight loss and internalized weight bias intervention with self-compassion exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 25, ≥ 18 years old
- Smartphone access
- WBIS score ≥ 4
Key exclusion criteria (6 listed)
- Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any major active kidney, liver, cardio, or cerebrovascular disease,
- musculoskeletal problems that would prevent physical activity,
- current weight loss medication or weight loss program,
- history of bariatric surgery,
- pregnant or breastfeeding,
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 |
|---|---|---|
| Weight loss plus self-compassionA novel weight loss approach combining a standard weight loss based on the Diabetes Prevention Program and internalized weight bias intervention with self-compassion exercises. | Behavioural | Intervention |
Primary outcome
Weight (lbs)
Time frame: 12 weeks
Change in weight or percent body weight
Weight Bias Internalization Scale
Time frame: 12 weeks
Change in internalized weight bias (range 1-7 with higher scores indicating greater internalized weight bias)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Yes. I am happy to make data available to qualified researchers.
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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.
Abbie Metzler contact
Robert Carels principal investigator
East Carolina University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss plus self-compassion in people with Overweight and Obesity, run by East Carolina University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Carels (4193782704, carelsr14@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (lbs) (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 14 Nov 2023.