Binge Eating, Binge-Eating Disorder, Eating Disorder, Weight Loss
Conditions
Keywords
Eating Disorder, Binge Eating, Binge Eating Disorder, Weight Loss
Brief 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.
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.
Interventions
BEHAVIORALAcceptance-Based Behavioral Weight Loss Therapy for BED
ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
BEHAVIORALStandard Behavior Therapy
SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Meet the DSM-5 criteria for Binge Eating Disorder * Have a BMI range of 27-50kg/m2
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating Disorder Examination Questionnaire | Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABBT Weight Loss Therapy for BED Acceptance-Based Behavioral Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED: ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED. | 63 |
| Standard Behavior Therapy Standard Behavioral Weight Loss Therapy
Standard Behavior Therapy: SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies. | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | ABBT Weight Loss Therapy for BED | Standard Behavior Therapy | Total |
|---|---|---|---|
| Age, Continuous | 51.56 years STANDARD_DEVIATION 12.41 | 51.05 years STANDARD_DEVIATION 11.6 | 51.30 years STANDARD_DEVIATION 11.96 |
| Baseline EDE Global Score | 2.29 scores on a scale STANDARD_DEVIATION 0.68 | 1.72 scores on a scale STANDARD_DEVIATION 0.76 | 2.01 scores on a scale STANDARD_DEVIATION 0.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 54 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 15 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 44 Participants | 44 Participants | 88 Participants |
| Region of Enrollment United States | 63 participants | 63 participants | 126 participants |
| Sex: Female, Male Female | 51 Participants | 49 Participants | 100 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
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).
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBT Weight Loss Therapy for BED | Weight Loss | 1 Month | -2.13 percentage of weight loss | Standard Deviation 3.68 |
| ABBT Weight Loss Therapy for BED | Weight Loss | 6 Months | -7.65 percentage of weight loss | Standard Deviation 7.37 |
| ABBT Weight Loss Therapy for BED | Weight Loss | Baseline | 0 percentage of weight loss | Standard Deviation 0 |
| ABBT Weight Loss Therapy for BED | Weight Loss | Post-Treatment | -7.46 percentage of weight loss | Standard Deviation 9.67 |
| ABBT Weight Loss Therapy for BED | Weight Loss | 3 Months | -5.46 percentage of weight loss | Standard Deviation 5.41 |
| ABBT Weight Loss Therapy for BED | Weight Loss | 1 Year Follow-Up | -4.76 percentage of weight loss | Standard Deviation 9.01 |
| Standard Behavior Therapy | Weight Loss | 3 Months | -5.25 percentage of weight loss | Standard Deviation 4.32 |
| Standard Behavior Therapy | Weight Loss | Baseline | 0 percentage of weight loss | Standard Deviation 0 |
| Standard Behavior Therapy | Weight Loss | 1 Month | -2.15 percentage of weight loss | Standard Deviation 2.85 |
| Standard Behavior Therapy | Weight Loss | 1 Year Follow-Up | -3.52 percentage of weight loss | Standard Deviation 7.02 |
| Standard Behavior Therapy | Weight Loss | 6 Months | -6.97 percentage of weight loss | Standard Deviation 5.92 |
| Standard Behavior Therapy | Weight Loss | Post-Treatment | -7.06 percentage of weight loss | Standard Deviation 7.42 |
Secondary
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.
Time frame: Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBT Weight Loss Therapy for BED | Eating Disorder Examination Questionnaire | Baseline | 2.29 score on a scale | Standard Deviation 0.68 |
| ABBT Weight Loss Therapy for BED | Eating Disorder Examination Questionnaire | Post-Treatment | 2.49 score on a scale | Standard Deviation 0.77 |
| ABBT Weight Loss Therapy for BED | Eating Disorder Examination Questionnaire | 1 Year Follow-Up | 1.50 score on a scale | Standard Deviation 0.7 |
| Standard Behavior Therapy | Eating Disorder Examination Questionnaire | Baseline | 1.72 score on a scale | Standard Deviation 0.76 |
| Standard Behavior Therapy | Eating Disorder Examination Questionnaire | Post-Treatment | 1.49 score on a scale | Standard Deviation 0.78 |
| Standard Behavior Therapy | Eating Disorder Examination Questionnaire | 1 Year Follow-Up | 1.60 score on a scale | Standard Deviation 0.81 |