Weight LossNCT05529758
Virtual Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program
A study testing Internalized Weight Bias Intervention in people with Weight Loss and Weight Prejudice, run by East Carolina University at 1 site in United States.
Trial summary
The current study aims to test a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software. 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, Weight Prejudice
- What is being tested?
- Internalized Weight Bias Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 15 Aug 2023
- 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
- Interested in weight loss
- 18 or older
- BMI of 25 kg/m2 or greater
- Higher-than-average levels of IWB
- Access to internet, along with a web camera and sound, and be able to use video conferencing software and attend weekly online groups, and access to a reliable scale to weigh themselves weekly
Who cannot join
- Individuals with current use of medication prescribed for weight loss (such as orlistat, sibutramine, or rimonabant)
- Pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: A Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program Using Video Conferencing Software
The current study aims to test a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software.
Read the detailed description
Internalized weight bias (IWB), has been shown to impact mental (e.g., depression and anxiety) and physical health (e.g., cardiometabolic functioning), as well as weight loss and weight loss associated behaviors (e.g., interference with exercise and healthy eating). These associated behaviors especially pose a risk for weight regain and disruption of healthy weight loss. Therefore, given the association between IWB and weight loss associated behaviors, as well as the psychological and health risks associated with IWB, it is clear that IWB interventions are also needed independently and in conjunction with behavioral weight loss programs (BWLPs). Interventions using third-wave strategies (such as acceptance commitment therapy; ACT) have begun to show promise in reducing IWB, but have not yet looked at this therapy in conjunction with a BWLP. Finally, there has also been a growing interest in and need for telehealth-based programs and interventions. The COVID19 pandemic demonstrated a clear need for efficacious telehealth programs, and a further benefit is that these programs may reach populations with limited access to resources (i.e., rural populations). Thus, the current study aims to examine a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software.
- Conditions
- Weight Loss, Weight Prejudice
- Being tested
- Internalized Weight Bias Intervention
- Keywords
- Behavioral Weight Loss Program
- Medical subject headings
- Weight Loss, Weight Prejudice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internalized Weight Bias InterventionBehavioural
ACT-based programs and self-compassion have shown promise throughout research for lowering IWB (Berman et al., 2016; Levin et al., 2018; Lillis et al., 2009; Palmeira, Cunha, \& Pinto-Gouveia, 2017; Palmeira, Pinto-Gouveia, \& Cunha, 2017; Forbes et al., 2020). Therefore, using techniques from prior ACT- and self-compassion based programs, a weight bias reduction intervention will be administered. Session topics will include psychoeducation and coping for weight bias and internal weight bias, and these topics will be viewed through a self-compassionate and ACT-based lens (for example, participants may defuse from internal critical thoughts rather than challenge them). Sessions will also cover acceptance, cognitive defusion, mindfulness, committed action, and the dialectical behavioral therapy (DBT) DEARMAN skill.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receives internalized weight bias intervention along with standard behavioral weight loss program Receives: Behavioral: Internalized Weight Bias Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight Change
Measured: Baseline to Week 10
Weight Bias Internalization Scale
Internalized Weight Bias, which is internalizing weight bias towards oneself, is scored on a scale of 1 to 7, with higher scores indicating greater weight bias internalization.
Measured: Baseline to Week 10
Weight Self-Stigma Questionnaire
Internalized Weight Bias, which is internalizing weight bias towards oneself, is summed on a scale of 12 to 60, with higher scores indicating greater weight bias internalization. Includes two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE), each summed on scale of 6-30.
Measured: Baseline to Week 10
Revised Morgenstern Physical Activity Questionnaire (PAQ-M)
The Revised Morgenstern Physical Activity Questionnaire assesses Physical Activity through 11 items, asking participants specifically about light, moderate, or rigorous exercise, recreational activities, home, volunteer, or work activities, and chores.
Measured: Baseline to Week 10
Diet History Questionnaire III (DHQ III)
The Diet History Questionnaire III assesses Eating Behavior, including various food items/groups (with 124 food items) and frequency and portion of each food item or group.
Measured: Baseline to Week 10
Three Factor Eating Questionnaire-R18 (TFEQ-18)
The Three Factor Eating Questionnaire-R18 is an 18-item measure designed to examine eating behavior through three subscales: cognitive restraint, uncontrolled eating and emotional eating using a 4-point Likert scale, using "definitely true" to "definitely false". Higher scores indicate more disordered eating.
Measured: Baseline to Week 10
Secondary outcomes (9)
Self-Compassion Scale
The Self-Compassion Scale is a 12-item scale that uses a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). The scale has six subscales; the first three represent crucial/core components of self-compassion: self-kindness, common humanity, and mindfulness, and the remaining three serve as counters to these core components, with self-judgement, isolation, and overidentification (becoming wrapped up in negative emotions). The three core components are added together, along with reverse-scored counter components, to create an overall score in which higher scores indicate higher self-compassion.
Measured: Baseline to Week 10
Brief Stigmatizing Situations Inventory
The Brief Stigmatizing Situations Inventory is a 10-item scale used to measure experiences of weight stigma, including items such as "Overhearing other people making rude remarks about you in public," on a Likert scale ranging from 0 (never) to 9 (daily), and higher scores indicating more situations encountered.
Measured: Baseline to Week 10
Depression Anxiety and Stress Scale - 21 Items (DASS-21)
The Depression Anxiety and Stress Scale assess depression, stress, anxiety, with score cut off's for...
- depression: normal: 0-9, mild: 10-12, moderate:13-20, severe: 21-27, and extremely severe: 28-42.
- anxiety: normal: 0-6, mild: 7-9, moderate: 10-14, severe:15-19, and extremely severe: 20-42.
- stress: normal: 0-10, mild:11-18, moderate:19-26, severe: 27-34, and extremely severe: 35-42.
Higher scores equate higher depression, anxiety, and stress.
Measured: Baseline to Week 10
Rosenberg Self-Esteem Scale
Self-Esteem will be measured utilizing the 10-item Rosenberg Self-Esteem Scale (RSES). The RSES uses a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), which higher scores indicating higher self-esteem.
Measured: Baseline to Week 10
The Acceptance and Action Questionnaire - Second Edition (AAQ-II)
The Acceptance and Action Questionnaire is a 7-item questionnaire that uses a 7-point Likert scale from 1 (never true) to 7 (always true). Higher scores indicate less psychological flexibility and higher experiential avoidance.
Measured: Baseline to Week 10
Satisfaction with Therapist and Therapy Scale
The Satisfaction with Therapist and Therapy Scale assesses satisfaction with therapy and therapist using a 5-point Likert scale, from 1 (Strongly Disagree) to 5 (Strongly Agree). Questions regarding treatment will be adapted for the telehealth, BWLP situation (i.e., "I am satisfied with the quality of the therapy I received" will be adapted to "I am satisfied with the quality of the telehealth weight loss treatment I received"). Similarly, questions about the therapist will be changed to "weight loss coach."
Measured: Baseline to Week 10
Ruminative Response Scale - Short Form
The Ruminative Response Scale - Short Form includes nine items with two subscales; brooding and reflection. The form utilizes a 4-point Likert scale ranging from 1 ("almost never") to 4 ("almost always") for various aspects of rumination. Higher scores indicate more rumination.
Measured: Baseline to Week 10
Universal Measure of Bias (UMB-FAT)
The Universal Measure of Bias (UMB-FAT) is a 20-item scale that assesses attitudes towards fat, using a 7-point scale with "strongly agree" to "strongly disagree." It includes four subscales: negative judgment (dislike towards individuals with overweight or obesity), distance (comfort with individuals with overweight or obesity in social situations), equal rights (assessing the belief that individuals with overweight or obesity deserve legal protection against discrimination) and attraction (the extent to which the participant finds individuals with overweight or obesity to be attractive). Higher scores indicating greater weight bias by the participant.
Measured: Baseline to Week 10
The Eating Disorder Diagnostic Scale
The Eating Disorder Diagnostic Scale - DSM 5 Version is 22-item a questionnaire designed to assess symptoms of anorexia nervosa, bulimia nervosa, and binge-eating disorder per DSM-5 criteria. The questions vary in terms of format, using 6-point Likert ratings from "Not at all" to "Extremely," dichotomous items and asking about frequency of diagnostically relevant behavior over a set period of time (i.e., days per week for over X amount of months)
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start15 Aug 2022
- Primary completion15 May 2023
- Study completion15 Aug 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Porter-, East Carolina University
- Investigators
- Julia C Miller, MA, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529758
- Sponsor's protocol ID
- 22-001438
- Status last verified
- Mar 2024
- First submitted
- 19 Aug 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program Using Video Conferencing Software
- ClinicalTrials.gov ID
- NCT05529758
- Acronym / sponsor ID
- 22-001438
- Conditions
- Weight Loss, Weight Prejudice
- Keywords
- Behavioral Weight Loss Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 7 Sep 2022 (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 aims to test a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software.
Detailed description
Internalized weight bias (IWB), has been shown to impact mental (e.g., depression and anxiety) and physical health (e.g., cardiometabolic functioning), as well as weight loss and weight loss associated behaviors (e.g., interference with exercise and healthy eating). These associated behaviors especially pose a risk for weight regain and disruption of healthy weight loss. Therefore, given the association between IWB and weight loss associated behaviors, as well as the psychological and health risks associated with IWB, it is clear that IWB interventions are also needed independently and in conjunction with behavioral weight loss programs (BWLPs). Interventions using third-wave strategies (such as acceptance commitment therapy; ACT) have begun to show promise in reducing IWB, but have not yet looked at this therapy in conjunction with a BWLP. Finally, there has also been a growing interest in and need for telehealth-based programs and interventions. The COVID19 pandemic demonstrated a clear need for efficacious telehealth programs, and a further benefit is that these programs may reach populations with limited access to resources (i.e., rural populations). Thus, the current study aims to examine a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Internalized Weight Bias InterventionReceives internalized weight bias intervention along with standard behavioral weight loss program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Interested in weight loss
- 18 or older
- BMI of 25 kg/m2 or greater
- Higher-than-average levels of IWB
- Access to internet, along with a web camera and sound, and be able to use video conferencing software and attend weekly online groups, and access to a reliable scale to weigh themselves weekly
Key exclusion criteria (2 listed)
- Individuals with current use of medication prescribed for weight loss (such as orlistat, sibutramine, or rimonabant)
- Pregnant or planning to become pregnant
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 |
|---|---|---|
| Internalized Weight Bias InterventionACT-based programs and self-compassion have shown promise throughout research for lowering IWB (Berman et al., 2016; Levin et al., 2018; Lillis et al., 2009; Palmeira, Cunha, \& Pinto-Gouveia, 2017; Palmeira, Pinto-Gouveia, \& Cunha, 2017; Forbes et al., 2020). Therefore, using techniques from prior ACT- and self-compassion based programs, a weight bias reduction intervention will be administered. Session topics will include psychoeducation and coping for weight bias and internal weight bias, and these topics will be viewed through a self-compassionate and ACT-based lens (for example, participants may defuse from internal critical thoughts rather than challenge them). Sessions will also cover acceptance, cognitive defusion, mindfulness, committed action, and the dialectical behavioral therapy (DBT) DEARMAN skill. | Behavioural | Intervention Group |
Primary outcome
Weight Change
Time frame: Baseline to Week 10
Weight Change
Weight Bias Internalization Scale
Time frame: Baseline to Week 10
Internalized Weight Bias, which is internalizing weight bias towards oneself, is scored on a scale of 1 to 7, with higher scores indicating greater weight bias internalization.
Weight Self-Stigma Questionnaire
Time frame: Baseline to Week 10
Internalized Weight Bias, which is internalizing weight bias towards oneself, is summed on a scale of 12 to 60, with higher scores indicating greater weight bias internalization. Includes two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE), each summed on scale of 6-30.
Revised Morgenstern Physical Activity Questionnaire (PAQ-M)
Time frame: Baseline to Week 10
The Revised Morgenstern Physical Activity Questionnaire assesses Physical Activity through 11 items, asking participants specifically about light, moderate, or rigorous exercise, recreational activities, home, volunteer, or work activities, and chores.
Diet History Questionnaire III (DHQ III)
Time frame: Baseline to Week 10
The Diet History Questionnaire III assesses Eating Behavior, including various food items/groups (with 124 food items) and frequency and portion of each food item or group.
Three Factor Eating Questionnaire-R18 (TFEQ-18)
Time frame: Baseline to Week 10
The Three Factor Eating Questionnaire-R18 is an 18-item measure designed to examine eating behavior through three subscales: cognitive restraint, uncontrolled eating and emotional eating using a 4-point Likert scale, using "definitely true" to "definitely false". Higher scores indicate more disordered eating.
9 secondary outcomes
Self-Compassion Scale
Time frame: Baseline to Week 10
Brief Stigmatizing Situations Inventory
Time frame: Baseline to Week 10
Depression Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: Baseline to Week 10
Rosenberg Self-Esteem Scale
Time frame: Baseline to Week 10
The Acceptance and Action Questionnaire - Second Edition (AAQ-II)
Time frame: Baseline to Week 10
Satisfaction with Therapist and Therapy Scale
Time frame: Baseline to Week 10
Ruminative Response Scale - Short Form
Time frame: Baseline to Week 10
Universal Measure of Bias (UMB-FAT)
Time frame: Baseline to Week 10
The Eating Disorder Diagnostic Scale
Time frame: Baseline to Week 10
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 5 Mar 2024.
- Individual participant dataSharing planned: No. Participant data will be kept confidential.
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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.
Julia C Miller, MA 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 Internalized Weight Bias Intervention in people with Weight Loss and Weight Prejudice, 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 5 inclusion and 2 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 5 Mar 2024. 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 Change (time frame: Baseline to Week 10). The study lists 6 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 5 Mar 2024.