Eating DisorderNCT03712462
Improving Weight Loss Outcomes for Binge Eating Disorder.
A study testing Acceptance-Based Behavioral Weight Loss Therapy for BED and Standard Behavior Therapy in people with Eating Disorder and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
Trial summary
This study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eating Disorder, Binge-Eating Disorder, Weight Loss
- What is being tested?
- Acceptance-Based Behavioral Weight Loss Therapy for BED and Standard Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the DSM-5 criteria for Binge Eating Disorder
- Have a BMI range of 27-50kg/m2
Who cannot join
- are unable to fluently speak, write, and read English
- are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., suicidality, substance use disorder, psychotic disorder)
- are unable to engage in moderate physical activity (i.e., walk 2 blocks without rest)
- have a medical condition (e.g., acute coronary syndrome, type I diabetes) that would pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the recommendations of the program
- Pregnant or planning to become pregnant in the next 2 years
- Recently began a course of or changed the dosage of medication that can cause significant change in weight
- Have a history of bariatric surgery
- Have had weight loss of > 5% in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University, Stratton Hall
Philadelphia, Pennsylvania, 19104
About this study
This study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight.
Read the detailed description
In the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (ABBT) that targets both binge eating and weight loss in patients with binge eating disorder (BED) to a Standard Behavioral Weight Loss Treatment (SBT), (b) evaluate the extent to which ABBT and SBT target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in ABBT. Our study will be the first to evaluate an ABBT for BED designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to BWL prescriptions.
- Conditions
- Eating Disorder, Binge-Eating Disorder, Weight Loss, Binge Eating
- Being tested
- Acceptance-Based Behavioral Weight Loss Therapy for BED, Standard Behavior Therapy
- Keywords
- Eating Disorder, Binge Eating, Binge Eating Disorder, Weight Loss
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Weight Loss, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-Based Behavioral Weight Loss Therapy for BEDBehavioural
ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
Standard Behavior TherapyBehavioural
SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
| Study group | Role | What they receive |
|---|---|---|
| ABBT Weight Loss Therapy for BED | Experimental | Acceptance-Based Behavioral Weight Loss Therapy for BED Receives: Behavioral: Acceptance-Based Behavioral Weight Loss Therapy for BED |
| Standard Behavior Therapy | Active comparator | Standard Behavioral Weight Loss Therapy Receives: Behavioral: Standard Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline).
Measured: Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)
Secondary outcomes (1)
Eating Disorder Examination Questionnaire
The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint.
Assessing changes in EDE Global score.
Measured: Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start20 Aug 2018
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The novel acceptance-based behavioral weight loss therapy is being compared to standard behavioral weight loss therapy for individuals with binge eating disorder.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712462
- Sponsor's protocol ID
- 1803006178
- Other IDs
- R01DK117072
- Status last verified
- Apr 2024
- First submitted
- 17 Oct 2018
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Weight Loss Outcomes for Binge Eating Disorder.
- ClinicalTrials.gov ID
- NCT03712462
- Acronym / sponsor ID
- 1803006178
- Conditions
- Eating Disorder, Binge-Eating Disorder, Weight Loss, Binge Eating
- Keywords
- Eating Disorder, Binge Eating, Binge Eating Disorder, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight.
Detailed description
In the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (ABBT) that targets both binge eating and weight loss in patients with binge eating disorder (BED) to a Standard Behavioral Weight Loss Treatment (SBT), (b) evaluate the extent to which ABBT and SBT target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in ABBT. Our study will be the first to evaluate an ABBT for BED designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to BWL prescriptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The novel acceptance-based behavioral weight loss therapy is being compared to standard behavioral weight loss therapy for individuals with binge eating disorder.
| Arm | Type | Receives |
|---|---|---|
| ABBT Weight Loss Therapy for BED | Experimental | Behavioral: Acceptance-Based Behavioral Weight Loss Therapy for BEDAcceptance-Based Behavioral Weight Loss Therapy for BED |
| Standard Behavior Therapy | Active comparator | Behavioral: Standard Behavior TherapyStandard Behavioral Weight Loss Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the DSM-5 criteria for Binge Eating Disorder
- Have a BMI range of 27-50kg/m2
Key exclusion criteria (8 listed)
- are unable to fluently speak, write, and read English
- are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., suicidality, substance use disorder, psychotic disorder)
- are unable to engage in moderate physical activity (i.e., walk 2 blocks without rest)
- have a medical condition (e.g., acute coronary syndrome, type I diabetes) that would pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the recommendations of the program
- Pregnant or planning to become pregnant in the next 2 years
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 |
|---|---|---|
| Acceptance-Based Behavioral Weight Loss Therapy for BEDABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED. | Behavioural | ABBT Weight Loss Therapy for BED |
| Standard Behavior TherapySBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. | Behavioural | Standard Behavior Therapy |
Primary outcome
Weight Loss
Time frame: Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)
Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline).
1 secondary outcome
Eating Disorder Examination Questionnaire
Time frame: Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-Based Behavioral Weight Loss Therapy for BED and Standard Behavior Therapy in people with Eating Disorder and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Loss (time frame: Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)). 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 26 Apr 2024.