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FReedom From Emotional Eating

Primary Purpose

Overweight and Obesity, Emotional Eating

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DBT+BWL
Sponsored by
Bowling Green State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring emotional eating, Dialectical Behavioral Therapy

Eligibility Criteria

22 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DBT and behavioral weight loss

    Arm Description

    The intervention is a 16-week group-based behavioral program consisting of a combination of Dialectical Behavioral Therapy (DBT) skills and behavioral weight loss techniques.

    Outcomes

    Primary Outcome Measures

    change in body weight
    body weight measured in kilograms

    Secondary Outcome Measures

    change in body mass index (BMI)
    body weight in kilograms and height in meters will be used to calculate BMI (kg/m2)
    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.
    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.
    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.

    Full Information

    First Posted
    November 27, 2019
    Last Updated
    December 2, 2019
    Sponsor
    Bowling Green State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04185506
    Brief Title
    FReedom From Emotional Eating
    Official Title
    FReedom From Emotional Eating: Weight Loss Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 16, 2016 (Actual)
    Primary Completion Date
    November 17, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bowling Green State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity, Emotional Eating
    Keywords
    emotional eating, Dialectical Behavioral Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DBT and behavioral weight loss
    Arm Type
    Experimental
    Arm Description
    The intervention is a 16-week group-based behavioral program consisting of a combination of Dialectical Behavioral Therapy (DBT) skills and behavioral weight loss techniques.
    Intervention Type
    Behavioral
    Intervention Name(s)
    DBT+BWL
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    change in body weight
    Description
    body weight measured in kilograms
    Time Frame
    10 months
    Secondary Outcome Measure Information:
    Title
    change in body mass index (BMI)
    Description
    body weight in kilograms and height in meters will be used to calculate BMI (kg/m2)
    Time Frame
    10 months
    Title
    change in emotional eating
    Description
    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.
    Time Frame
    10 months
    Title
    change in emotion regulation
    Description
    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.
    Time Frame
    10 months
    Title
    change in use of Dialectical Behavior Therapy (DBT) skills
    Description
    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.
    Time Frame
    10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

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    FReedom From Emotional Eating

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