Virtual Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program
Primary Purpose
Weight Loss, Weight Prejudice
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internalized Weight Bias Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Behavioral Weight Loss Program
Eligibility Criteria
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
Sites / Locations
- East Carolina University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
Receives internalized weight bias intervention along with standard behavioral weight loss program
Outcomes
Primary Outcome Measures
Weight Change
Weight Change
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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."
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.
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.
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)
Full Information
NCT ID
NCT05529758
First Posted
August 19, 2022
Last Updated
February 13, 2023
Sponsor
East Carolina University
1. Study Identification
Unique Protocol Identification Number
NCT05529758
Brief Title
Virtual Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program
Official Title
A Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program Using Video Conferencing Software
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Prejudice
Keywords
Behavioral Weight Loss Program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Receives internalized weight bias intervention along with standard behavioral weight loss program
Intervention Type
Behavioral
Intervention Name(s)
Internalized Weight Bias Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Change
Description
Weight Change
Time Frame
Baseline to Week 10
Title
Weight Bias Internalization Scale
Description
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.
Time Frame
Baseline to Week 10
Title
Weight Self-Stigma Questionnaire
Description
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.
Time Frame
Baseline to Week 10
Title
Revised Morgenstern Physical Activity Questionnaire (PAQ-M)
Description
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.
Time Frame
Baseline to Week 10
Title
Diet History Questionnaire III (DHQ III)
Description
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.
Time Frame
Baseline to Week 10
Title
Three Factor Eating Questionnaire-R18 (TFEQ-18)
Description
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.
Time Frame
Baseline to Week 10
Secondary Outcome Measure Information:
Title
Self-Compassion Scale
Description
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.
Time Frame
Baseline to Week 10
Title
Brief Stigmatizing Situations Inventory
Description
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.
Time Frame
Baseline to Week 10
Title
Depression Anxiety and Stress Scale - 21 Items (DASS-21)
Description
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.
Time Frame
Baseline to Week 10
Title
Rosenberg Self-Esteem Scale
Description
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.
Time Frame
Baseline to Week 10
Title
The Acceptance and Action Questionnaire - Second Edition (AAQ-II)
Description
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.
Time Frame
Baseline to Week 10
Title
Satisfaction with Therapist and Therapy Scale
Description
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."
Time Frame
Baseline to Week 10
Title
Ruminative Response Scale - Short Form
Description
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.
Time Frame
Baseline to Week 10
Title
Universal Measure of Bias (UMB-FAT)
Description
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.
Time Frame
Baseline to Week 10
Title
The Eating Disorder Diagnostic Scale
Description
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)
Time Frame
Baseline to Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia C Miller, MA
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be kept confidential.
Learn more about this trial
Virtual Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program
We'll reach out to this number within 24 hrs