Clinical trial NCT05529758: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight Prejudice
Keywords: Behavioral Weight Loss Program
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion:

1. Interested in weight loss
2. 18 or older
3. BMI of 25 kg/m2 or greater
4. Higher-than-average levels of IWB
5. 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:
6. Individuals with current use of medication prescribed for weight loss (such as orlistat, sibutramine, or rimonabant)
7. Pregnant or planning to become pregnant

Primary outcomes:
measure: Weight Change
timeFrame: Baseline to Week 10
measure: Weight Bias Internalization Scale
timeFrame: Baseline to Week 10
measure: Weight Self-Stigma Questionnaire
timeFrame: Baseline to Week 10
measure: Revised Morgenstern Physical Activity Questionnaire (PAQ-M)
timeFrame: Baseline to Week 10
measure: Diet History Questionnaire III (DHQ III)
timeFrame: Baseline to Week 10
measure: Three Factor Eating Questionnaire-R18 (TFEQ-18)
timeFrame: Baseline to Week 10
Secondary outcomes:
measure: Self-Compassion Scale
timeFrame: Baseline to Week 10
measure: Brief Stigmatizing Situations Inventory
timeFrame: Baseline to Week 10
measure: Depression Anxiety and Stress Scale - 21 Items (DASS-21)
timeFrame: Baseline to Week 10
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline to Week 10
measure: The Acceptance and Action Questionnaire - Second Edition (AAQ-II)
timeFrame: Baseline to Week 10
measure: Satisfaction with Therapist and Therapy Scale
timeFrame: Baseline to Week 10
measure: Ruminative Response Scale - Short Form
timeFrame: Baseline to Week 10
measure: Universal Measure of Bias (UMB-FAT)
timeFrame: Baseline to Week 10
measure: The Eating Disorder Diagnostic Scale
timeFrame: Baseline to Week 10
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Julia C Miller, MA
role: PRINCIPAL_INVESTIGATOR
References: