Clinical trial NCT05987306: A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
Official title: A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: University of South Alabama
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre and posttest design.
Primary purpose: TREATMENT

Brief summary: The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question\[s\] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software.

Detailed description: The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question\[s\] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12-week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. The weight loss approach will be modeled after the Diabetes Prevention Program and the approach utilized to reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each weekly session will utilize Webex videoconferencing software and last approximately 60-90 minutes.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25, ≥ 18 years old
* Smartphone access
* WBIS score ≥ 4

Exclusion Criteria:

* Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any major active kidney, liver, cardio, or cerebrovascular disease,
* musculoskeletal problems that would prevent physical activity,
* current weight loss medication or weight loss program,
* history of bariatric surgery,
* pregnant or breastfeeding,
* eating disorder except binge eating disorder

Primary outcomes:
measure: Weight (lbs)
timeFrame: 12 weeks
measure: Weight Bias Internalization Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Greenville
country: United States
facility: ECU, Dept of Psychology, 104 Rawl
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Robert Carels
role: PRINCIPAL_INVESTIGATOR
References: