- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05529758
Virtual Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program
March 3, 2024 updated by: Caroline Porter-, East Carolina University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Greenville, North Carolina, United States, 27858
- East Carolina University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion:
- 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
Exclusion:
- Individuals with current use of medication prescribed for weight loss (such as orlistat, sibutramine, or rimonabant)
- Pregnant or planning to become pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Receives internalized weight bias intervention along with standard behavioral weight loss program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change
Time Frame: Baseline to Week 10
|
Weight Change
|
Baseline to Week 10
|
|
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.
|
Baseline to Week 10
|
|
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.
|
Baseline to Week 10
|
|
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.
|
Baseline to Week 10
|
|
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.
|
Baseline to Week 10
|
|
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.
|
Baseline to Week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion Scale
Time Frame: Baseline to Week 10
|
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.
|
Baseline to Week 10
|
|
Brief Stigmatizing Situations Inventory
Time Frame: Baseline to Week 10
|
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.
|
Baseline to Week 10
|
|
Depression Anxiety and Stress Scale - 21 Items (DASS-21)
Time Frame: Baseline to Week 10
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The Depression Anxiety and Stress Scale assess depression, stress, anxiety, with score cut off's for...
Higher scores equate higher depression, anxiety, and stress. |
Baseline to Week 10
|
|
Rosenberg Self-Esteem Scale
Time Frame: Baseline to Week 10
|
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.
|
Baseline to Week 10
|
|
The Acceptance and Action Questionnaire - Second Edition (AAQ-II)
Time Frame: Baseline to Week 10
|
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.
|
Baseline to Week 10
|
|
Satisfaction with Therapist and Therapy Scale
Time Frame: Baseline to Week 10
|
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."
|
Baseline to Week 10
|
|
Ruminative Response Scale - Short Form
Time Frame: Baseline to Week 10
|
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.
|
Baseline to Week 10
|
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Universal Measure of Bias (UMB-FAT)
Time Frame: Baseline to Week 10
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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.
|
Baseline to Week 10
|
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The Eating Disorder Diagnostic Scale
Time Frame: Baseline to Week 10
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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)
|
Baseline to Week 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julia C Miller, MA, East Carolina University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2022
Primary Completion (Actual)
May 15, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
September 2, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 3, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-001438
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participant data will be kept confidential.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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