FReedom From Emotional Eating

Overweight and Obesity Clinical Trial

Official title:

FReedom From Emotional Eating: Weight Loss Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04185506
• Other study ID #: 879234-12
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2019
• Source: Bowling Green State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: December 31, 2019
• Est. primary completion date: November 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Eating
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• DBT+BWL
DBT skills include a focus on emotion regulation, distress tolerance, and mindfulness techniques. BWL includes a focus on monitoring of food intake, calorie reduction, and dietary and physical activity education.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bowling Green State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight	body weight measured in kilograms	10 months
Secondary	change in body mass index (BMI)	body weight in kilograms and height in meters will be used to calculate BMI (kg/m2)	10 months
Secondary	change in emotional eating	Self-reported frequency of emotional eating is measured with the 25-item Emotional Eating Scale. Each item is scored on a 5-point scale ranging from 1 (no desire to eat) to 5 (overwhelming desire to eat). Total scores range from 25-125. Higher scores indicate more emotional eating.The Emotional Eating Scale yields 3 subscales: depression, anxiety/anger, and boredom.	10 months
Secondary	change in emotion regulation	Self-reported difficulties in emotion regulation is measured with the 36-item Difficulties in Emotion Regulation Scale. Each item is scored on a scale ranging from 1 (almost never) to 5 (almost always). Ten items are reverse scored. Higher scores indicate more problems with emotion regulation. Total scores range from 36-180.	10 months
Secondary	change in use of Dialectical Behavior Therapy (DBT) skills	The 38-item DBT skills subscale (DBT-WCCL-DSS) of the DBT Ways of Coping Checklist (DBT-WCCL) [37] is a self-report measure that assess DBT skills use. Items are scored on a scale ranging from 0 (never used) to 3 (regularly used). Higher scores indicate more frequent use of DBT skills. Total scores range from 0 - 114.	10 months