StigmatizationNCT03572218
Psychological Intervention to Reduce Weight Bias Internalization
A study testing BWL and BIAS in people with Stigmatization and Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stigmatization, Obesity, Weight Loss
- What is being tested?
- BWL and BIAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 18 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will be men and women ages 18-65 years.
- Participants must have obesity (defined as a BMI ≥ 30 kg/m2); report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview; and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview.
- Participants must be seeking weight loss.
- If currently taking medications, dosages must be stable for at least 3 months.
- Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables.
- Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months.
Show all 14Show fewer
- Eligible female patients will be:
- non-pregnant, evidenced by a negative urine dipstick pregnancy test
- non-lactating
- surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study
- Participants must:
- have a PCP who is responsible for providing routine care
- have reliable telephone service with which to participate in conference calls
- understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Who cannot join
- Applicants will be excluded if they have:
- a diagnosis of type I or II diabetes;
- uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);
- experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;
- lost ≥ 5% of their initial weight in the last 6 months;
- or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion.
Show all 11Show fewer
- Applicants with severe symptoms of mood (for example, BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program. Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion.
- Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated.
- Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area.
- Applicants will not be eligible if they have a history of bariatric surgery.
- Women who are nursing, pregnant, or planning to become pregnant in the next 12 months are not eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.
- Conditions
- Stigmatization, Obesity, Weight Loss
- Being tested
- BWL, BIAS
- Medical subject headings
- Stereotyping, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWLBehavioural
The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.
BIASBehavioural
Following 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management.
| Study group | Role | What they receive |
|---|---|---|
| BWL + BIAS | Experimental | The behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group will include standard BWL treatment (described in more detail in Intervention section) combined with a weight stigma-reduction intervention. During the initial 12 weeks, the weekly 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically in the context of weight management. Receives: Behavioral: BWL; Behavioral: BIAS |
| Standard BWL | Active comparator | The Standard BWL group will receive weekly BWL sessions (described in more detail in Intervention section) for 12 weeks, followed by every-other-week and monthly weight loss maintenance sessions from weeks 13-26. BWL content will last for 60 minutes, with an additional 30 minutes in this group devoted to discussing recipes and food preparation. Receives: Behavioral: BWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Bias Internalization
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 12
Secondary outcomes (18)
Weight Bias Internalization
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 26
Weight Self-Stigma Questionnaire (WSSQ)
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma
Measured: Baseline to week 12
Weight Self-Stigma Questionnaire (WSSQ)
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma
Measured: Baseline to week 26
Weight Bias
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Measured: Baseline to week 12
Weight Bias
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Measured: Baseline to week 26
Weight-Related Quality of Life
Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)
Measured: Baseline to week 12
Weight-Related Quality of Life
Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)
Measured: Baseline to week 26
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Measured: Baseline to week 12
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Measured: Baseline to week 26
Depression
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Measured: Baseline to week 12
Depression
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Measured: Baseline to week 26
Exercise Self-Efficacy
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Measured: Baseline to week 12
Exercise Self-Efficacy
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Measured: Baseline to week 26
Eating Self-Efficacy
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Measured: Baseline to week 12
Eating Self-Efficacy
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Measured: Baseline to week 26
Percent Weight Change
Estimated mean change in percent weight change. Weight measured in kilograms (kg).
Measured: Baseline to week 26
Waist Circumference
Estimated mean change in waist circumference (cm).
Measured: Baseline to week 26
Blood Pressure
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Measured: Baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start10 Apr 2018
- Primary completion9 Apr 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StigmatizationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Principal investigator, Rebecca L. Pearl, Ph.D., University of Pennsylvania
- Investigators
- Rebecca L Pearl, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572218
- Sponsor's protocol ID
- 829070
- Status last verified
- Sep 2020
- First submitted
- 4 Jun 2018
- Last updated
- 23 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pearl RL, Wadden TA, Bach C, Tronieri JS, Berkowitz RI. Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program. Obesity (Silver Spring). 2020 Oct;28(10):1878-1888. doi: 10.1002/oby.22931. Epub 2020 Aug 28.
PubMed 32860344
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
- ClinicalTrials.gov ID
- NCT03572218
- Acronym / sponsor ID
- 829070
- Conditions
- Stigmatization, Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BWL + BIAS | Experimental | Behavioral: BWL, Behavioral: BIASThe behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group will include standard BWL treatment (described in more detail in Intervention section) combined with a weight stigma-reduction intervention. During the initial 12 weeks, the weekly 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically in the context of weight management. |
| Standard BWL | Active comparator | Behavioral: BWLThe Standard BWL group will receive weekly BWL sessions (described in more detail in Intervention section) for 12 weeks, followed by every-other-week and monthly weight loss maintenance sessions from weeks 13-26. BWL content will last for 60 minutes, with an additional 30 minutes in this group devoted to discussing recipes and food preparation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Eligible participants will be men and women ages 18-65 years.
- Participants must have obesity (defined as a BMI ≥ 30 kg/m2); report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview; and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview.
- Participants must be seeking weight loss.
- If currently taking medications, dosages must be stable for at least 3 months.
- Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables.
Key exclusion criteria (11 listed)
- a diagnosis of type I or II diabetes;
- uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);
- experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;
- lost ≥ 5% of their initial weight in the last 6 months;
- or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion.
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 |
|---|---|---|
| BWLThe BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes. | Behavioural | BWL + BIAS, Standard BWL |
| BIASFollowing 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management. | Behavioural | BWL + BIAS |
Primary outcome
Weight Bias Internalization
Time frame: Baseline to week 12
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
18 secondary outcomes
Weight Bias Internalization
Time frame: Baseline to week 26
Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Baseline to week 12
Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Baseline to week 26
Weight Bias
Time frame: Baseline to week 12
Weight Bias
Time frame: Baseline to week 26
Weight-Related Quality of Life
Time frame: Baseline to week 12
Weight-Related Quality of Life
Time frame: Baseline to week 26
Perceived Stress
Time frame: Baseline to week 12
Perceived Stress
Time frame: Baseline to week 26
Depression
Time frame: Baseline to week 12
Depression
Time frame: Baseline to week 26
Exercise Self-Efficacy
Time frame: Baseline to week 12
Exercise Self-Efficacy
Time frame: Baseline to week 26
Eating Self-Efficacy
Time frame: Baseline to week 12
Eating Self-Efficacy
Time frame: Baseline to week 26
Percent Weight Change
Time frame: Baseline to week 26
Waist Circumference
Time frame: Baseline to week 26
Blood Pressure
Time frame: Baseline to week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32860344Pearl RL, Wadden TA, Bach C, Tronieri JS, Berkowitz RI. Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program. Obesity (Silver Spring). 2020 Oct;28(10):1878-1888. doi: 10.1002/oby.22931. Epub 2020 Aug 28.
Related trials for Stigmatization
Recruiting
Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol
Schizophrenia Disorder
Not yet recruitingPhase 3
A Study of Lebrikizumab in Adults and Adolescents With Face and Neck Atopic Dermatitis
Atopic Dermatitis
Active, not recruiting
Mobile Mental Health Stigma Reduction Intervention Among Black Adults
Anxiety, Depression
Recruiting
Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV
Hiv, Transmission Vertical
Active, not recruiting
Comparison of Acceptance and Commitment Therapy and Cognitive Behavior Therapy: Managing Psychological Distress and Its Multifaceted Impact on Stigmatization, Psychological Wellbeing, Social Support and Treatment Adherence in HIV/AIDS Patients
HIV - Human Immunodeficiency Virus, Psychological Distress
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.
Rebecca L Pearl, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWL and BIAS in people with Stigmatization and Obesity, run by University of Pennsylvania 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 14 inclusion and 11 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 23 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Bias Internalization (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572218, which also lists 1 linked publication.
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 23 Oct 2020.