Overweight and ObesityNCT04185506
FReedom From Emotional Eating
A study testing DBT+BWL in people with Overweight and Obesity and Emotional Eating, run by Bowling Green State University.
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. Read more about this study
- Who is it for?
- Ages 22 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Emotional Eating
- What is being tested?
- DBT+BWL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
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- current use of weight altering medications (e.g., phentermine)
- immediate plans for weight loss surgery
- current pregnancy or breastfeeding.
About this study
Official title: FReedom From Emotional Eating: Weight Loss Program
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.
Read the 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).
- Conditions
- Overweight and Obesity, Emotional Eating
- Being tested
- DBT+BWL
- Keywords
- emotional eating, Dialectical Behavioral Therapy
- Medical subject headings
- Overweight, Obesity, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT+BWLBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DBT and behavioral weight loss | Experimental | 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. Receives: Behavioral: DBT+BWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight
body weight measured in kilograms
Measured: 10 months
Secondary outcomes (4)
change in body mass index (BMI)
body weight in kilograms and height in meters will be used to calculate BMI (kg/m2)
Measured: 10 months
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.
Measured: 10 months
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.
Measured: 10 months
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start16 Apr 2016
- Primary completion17 Nov 2019
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bowling Green State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abby L. Braden, Ph.D., Bowling Green State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185506
- Sponsor's protocol ID
- 879234-12
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FReedom From Emotional Eating: Weight Loss Program
- ClinicalTrials.gov ID
- NCT04185506
- Acronym / sponsor ID
- 879234-12
- Conditions
- Overweight and Obesity, Emotional Eating
- Keywords
- emotional eating, Dialectical Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bowling Green State UniversityUniversity, hospital or other
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 17 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT and behavioral weight loss | Experimental | Behavioral: DBT+BWLThe intervention is a 16-week group-based behavioral program consisting of a combination of Dialectical Behavioral Therapy (DBT) skills and behavioral weight loss techniques. |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT+BWLDBT 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. | Behavioural | DBT and behavioral weight loss |
Primary outcome
change in body weight
Time frame: 10 months
body weight measured in kilograms
4 secondary outcomes
change in body mass index (BMI)
Time frame: 10 months
change in emotional eating
Time frame: 10 months
change in emotion regulation
Time frame: 10 months
change in use of Dialectical Behavior Therapy (DBT) skills
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DBT+BWL in people with Overweight and Obesity and Emotional Eating, run by Bowling Green State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body weight (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.