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Completed

NCT Number: NCT05529758

Virtual Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program

The current study aims to test a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27858, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internalized Weight Bias Intervention

Behavioral

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 outcomes

  1. Weight Change

    Time frame: Baseline to Week 10

    Weight Change

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Depression Anxiety and Stress Scale - 21 Items (DASS-21)

    Time frame: Baseline to Week 10

    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.

  4. 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.

  5. 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.

  6. 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."

  7. 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.

  8. Universal Measure of Bias (UMB-FAT)

    Time frame: Baseline to Week 10

    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.

  9. The Eating Disorder Diagnostic Scale

    Time frame: Baseline to Week 10

    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)

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

A Third-Wave Intervention for Internalized Weight Bias Combined With a Weight Loss Program Using Video Conferencing Software

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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