Clinical trial NCT04185506: FReedom From Emotional Eating
Official title: FReedom From Emotional Eating: Weight Loss Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Emotional Eating
Keywords: emotional eating
Dialectical Behavioral Therapy
Lead sponsor: Bowling Green State University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study was a pilot study examining a novel treatment for weight loss and emotional eating. The intervention is a group-based approach, and it includes a focus on teaching emotion regulation skills from Dialectical Behavioral Therapy and traditional behavioral weight loss techniques. The goal of the study was to develop and refine the treatment protocol. Additional goals of the study were to evaluate feasibility and acceptability, to see whether the intervention could be administered and whether participants like the treatment and believe it helps them. Changes in weight and emotional eating from baseline to post-treatment will also be measured.

Detailed description: Background: The current study was a preliminary investigation of Live FREE, a pilot study of a treatment that included a combination of Dialectical Behavioral Therapy (DBT) and Behavioral Weight Loss (BWL) techniques for overweight/obese adult emotional eaters. Live FREE was based on the premise that impaired emotion regulation skills promote emotional eating behavior and lead to weight gain. Consistent with the ORBIT model (Czajkowski et al., 2015) of behavioral treatment development, the primary study aim was to refine the treatment protocol.

Methods: Adults with overweight/obesity who self-identified as emotional eaters were enrolled in Live FREE. Participants completed assessments at baseline, post-treatment, and at a 6-month follow-up. The intervention delivered 10-weeks of emotion regulation skills training followed by 6-weeks of BWL treatment in a group-based format. Groups were co-led by a licensed clinical psychologist and a doctoral student. Feasibility and acceptability will be examined by calculating rate of enrollment into the study and session attendance. ANOVA will be used to examine changes in primary and secondary outcome variables (weight, emotional eating) over time. Effect sizes (Cohen's d) will be calculated to examine the magnitude of change observed in these outcomes using standard interpretation guidelines ( d=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size).

Eligibility criteria: Inclusion Criteria:

* ability to read English at a 6th grade level
* willingness and ability to participate in study-related assessments and treatment visits. - - Subjects also had to report elevated levels of emotional eating. Elevated self-reported emotional eating occurred when subjects' self-reported emotional eating score was above the mean at least one of the sub scales of the Emotional Eating Scale (depression ≥ 21; EES-anxiety/anger ≥ 17; EES-boredom ≥ 21).

Exclusion Criteria:

* past or present medical condition that required physician monitoring to participate (i.e., history of coronary heart disease, hepatic disease, renal disease, stroke, seizures, or myocardial infarction; symptoms of angina; uncontrolled hypertension; diabetes; protein wasting disease/Cushing's syndrome; osteoarthritis; osteoporosis; orthopedic problems that would limit activity; or any other serious medical condition that would make physical activity unsafe)
* concurrent psychotherapy treatment
* concurrent enrollment in a weight loss program
* unstable dosage of psychotropic medication in the previous 3 months
* regular use of purging or other compensatory behaviors in the previous 3 months
* psychiatric conditions that would interfere with study participation (e.g., psychosis, current alcohol or drug use disorder, severe depression or suicidal behaviors within the past month)
* current use of weight altering medications (e.g., phentermine)
* immediate plans for weight loss surgery
* current pregnancy or breastfeeding.

Primary outcomes:
measure: change in body weight
timeFrame: 10 months
Secondary outcomes:
measure: change in body mass index (BMI)
timeFrame: 10 months
measure: change in emotional eating
timeFrame: 10 months
measure: change in emotion regulation
timeFrame: 10 months
measure: change in use of Dialectical Behavior Therapy (DBT) skills
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
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