Binge Eating
Conditions
Keywords
Binge Eating Spectrum, Cognitive-behavioral therapy, Body Image
Brief summary
Twenty women, ages 60 or older, will be consented and enrolled in a single-arm, pilot implementation trial of the age-tailored cognitive-behavioral based BE intervention. Participants will complete assessments at baseline, post-intervention, and at two follow-up timepoints; weekly BE frequency will be collected to monitor progress during the intervention period.
Detailed description
The intervention being studied will be an age-tailored, cognitive-behavioral therapy (CBT) based behavioral intervention for binge eating (BE), delivered by the PI, a licensed clinical psychologist, in small group format (4-6 participants per group) over 12-16 weeks. The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. The final session number, frequency, content, and timeline will be determined during intervention-tailoring process not a part of this clinical trial.
Interventions
BEHAVIORALBinge Eating Syndrome Treatment (BESTOW)
The BESTOW program involves discussions as well as written and behavioral activities. Participants will also be asked to complete activities, or 'homework,' in between sessions that will help to stop binge eating and to improve eating habits.
Sponsors
National Institute on Aging (NIA)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a beta-testing of a new behavioral intervention treatment - all participants will be assigned to the treatment and give feedback on the treatment throughout the study.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women * Age 60 years and over * Binge eating (BE) ≥1/week during the past ≥3 months * Community-dwelling * Able to provide informed consent * Consistent medication regimen for 3 months
Exclusion criteria
* Significant cognitive impairment * Nursing home, long-term care facility * Psychosis or imminent suicide risk * Current BE treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Usage Rating Profile - Intervention | 6 weeks (post), and 2 month follow-up | Score on the Feasibility Usage Rating Profile. This scale gathers patient reported feasibility of the intervention (e.g., time needed, quality of materials, simplicity of the intervention) to be completed after doing the intervention. This scale has six items; total scores range from 1-6 and a higher scores indicate greater feasibility. |
| Acceptability - Usage Rating Profile - Intervention | 6 weeks (post), and 2 month follow-up | Score on the Acceptability Usage Rating Profile scale which gathers participant ratings of how acceptable the treatment is for targeting binge eating (e.g., how helpful the intervention was, how much they liked it, willingness to do the intervention) to be completed after doing the intervention. This scale has eight items; total scores range from 1-6, a higher score indicates greater acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Score (BES) | Baseline, 6 weeks, 1 month, and 2 month follow-up | Change in score on the BES survey. The BES is a 16-item, self-report survey that assess binge eating. Total scores range from 0 to 46, with higher scores meaning more severe binge eating symptoms (Gormally et al., 1982). |
| Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) | Baseline, 6 weeks (post), 1 month, and 2 month follow-up | The CES-D is a 10-item, self-report survey that assess depressive symptoms. Mean scores range from 0 to 3, with higher scores indicating more depressive symptoms (Lewinsohn et al., 1997). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BESTOW Behavioral Intervention The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity.
Binge Eating Syndrome Treatment (BESTOW): The BESTOW program involves discussions as well as written and behavioral activities. Participants will also be asked to complete activities, or 'homework,' in between sessions that will help to stop binge eating and to improve eating habits. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | BESTOW Behavioral Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 65.3 years STANDARD_DEVIATION 4.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Acceptability - Usage Rating Profile - Intervention
Score on the Acceptability Usage Rating Profile scale which gathers participant ratings of how acceptable the treatment is for targeting binge eating (e.g., how helpful the intervention was, how much they liked it, willingness to do the intervention) to be completed after doing the intervention. This scale has eight items; total scores range from 1-6, a higher score indicates greater acceptability.
Time frame: 6 weeks (post), and 2 month follow-up
Population: Post-assessment completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BESTOW Behavioral Intervention | Acceptability - Usage Rating Profile - Intervention | 6 weeks (post assessment) | 5.58 score on a scale | Standard Deviation 0.75 |
| BESTOW Behavioral Intervention | Acceptability - Usage Rating Profile - Intervention | 2-month follow-up | 5.50 score on a scale | Standard Deviation 0.76 |
Primary
Feasibility - Usage Rating Profile - Intervention
Score on the Feasibility Usage Rating Profile. This scale gathers patient reported feasibility of the intervention (e.g., time needed, quality of materials, simplicity of the intervention) to be completed after doing the intervention. This scale has six items; total scores range from 1-6 and a higher scores indicate greater feasibility.
Time frame: 6 weeks (post), and 2 month follow-up
Population: Post-assessment completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BESTOW Behavioral Intervention | Feasibility - Usage Rating Profile - Intervention | 6 weeks (Post intervention) | 5.44 score on a scale | Standard Deviation 0.85 |
| BESTOW Behavioral Intervention | Feasibility - Usage Rating Profile - Intervention | 2-month follow-up | 5.53 score on a scale | Standard Deviation 0.83 |
Secondary
Binge Eating Score (BES)
Change in score on the BES survey. The BES is a 16-item, self-report survey that assess binge eating. Total scores range from 0 to 46, with higher scores meaning more severe binge eating symptoms (Gormally et al., 1982).
Time frame: Baseline, 6 weeks, 1 month, and 2 month follow-up
Population: Completers. One of the subjects was too busy to complete the questionnaire at the 1 month follow up, so only 16 participants were evaluable at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BESTOW Behavioral Intervention | Binge Eating Score (BES) | Baseline | 24.78 score on a scale | Standard Deviation 5.89 |
| BESTOW Behavioral Intervention | Binge Eating Score (BES) | Post | 14.81 score on a scale | Standard Deviation 5.87 |
| BESTOW Behavioral Intervention | Binge Eating Score (BES) | 1-month follow-up | 13.24 score on a scale | Standard Deviation 6.64 |
| BESTOW Behavioral Intervention | Binge Eating Score (BES) | 2-month follow-up | 13.81 score on a scale | Standard Deviation 9.08 |
Secondary
Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D)
The CES-D is a 10-item, self-report survey that assess depressive symptoms. Mean scores range from 0 to 3, with higher scores indicating more depressive symptoms (Lewinsohn et al., 1997).
Time frame: Baseline, 6 weeks (post), 1 month, and 2 month follow-up
Population: Completers. One of the subjects was too busy to complete the questionnaire at the 1 month follow up, so only 16 participants were evaluable at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BESTOW Behavioral Intervention | Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) | Baseline | 1.15 score on a scale | Standard Deviation 0.59 |
| BESTOW Behavioral Intervention | Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) | Post | 0.91 score on a scale | Standard Deviation 0.75 |
| BESTOW Behavioral Intervention | Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) | 1-month follow-up | 0.93 score on a scale | Standard Deviation 0.69 |
| BESTOW Behavioral Intervention | Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D) | 2-month follow-up | 1.00 score on a scale | Standard Deviation 0.81 |