Binge EatingBESTOWNCT05806788
Binge Eating Syndrome Treatment for Older Women (BESTOW)
A study testing Binge Eating Syndrome Treatment (BESTOW) in people with Binge Eating, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Binge Eating
- What is being tested?
- Binge Eating Syndrome Treatment (BESTOW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 14 Nov 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant cognitive impairment
- Nursing home, long-term care facility
- Psychosis or imminent suicide risk
- Current BE treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78253
About this study
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.
Read the 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.
- Conditions
- Binge Eating
- Being tested
- Binge Eating Syndrome Treatment (BESTOW)
- Keywords
- Binge Eating Spectrum, Cognitive-behavioral therapy, Body Image
- Medical subject headings
- Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binge Eating Syndrome Treatment (BESTOW)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BESTOW behavioral intervention | Experimental | 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. Receives: Behavioral: Binge Eating Syndrome Treatment (BESTOW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks (post), and 2 month follow-up
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.
Measured: 6 weeks (post), and 2 month follow-up
Secondary outcomes (2)
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).
Measured: Baseline, 6 weeks, 1 month, and 2 month follow-up
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).
Measured: Baseline, 6 weeks (post), 1 month, and 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start17 Feb 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 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 Binge EatingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lisa Kilpela, The University of Texas Health Science Center at San Antonio
- Investigators
- Lisa Kilpela, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806788
- Sponsor's protocol ID
- HSC20220898H
- Other IDs
- 5K76AG060003
- Acronym
- BESTOW
- Status last verified
- Dec 2024
- First submitted
- 22 Mar 2023
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per guidelines, we will publish deidentified data results from this trial via ClinicalTrials.gov within one year of study completion. Participants will be informed of this at the time of consent, if they are interested in learning the results from the study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binge Eating Syndrome Treatment for Older Women (BESTOW)
- ClinicalTrials.gov ID
- NCT05806788
- Acronym / sponsor ID
- BESTOW / HSC20220898H
- Conditions
- Binge Eating
- Keywords
- Binge Eating Spectrum, Cognitive-behavioral therapy, Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| BESTOW behavioral intervention | Experimental | Behavioral: Binge Eating Syndrome Treatment (BESTOW)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- Age 60 years and over
- Binge eating (BE) ≥1/week during the past ≥3 months
- Community-dwelling
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Significant cognitive impairment
- Nursing home, long-term care facility
- Psychosis or imminent suicide risk
- Current BE treatment
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 |
|---|---|---|
| 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. | Behavioural | BESTOW behavioral intervention |
Primary outcome
Feasibility - Usage Rating Profile - Intervention
Time frame: 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
Time frame: 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.
2 secondary outcomes
Binge Eating Score (BES)
Time frame: Baseline, 6 weeks, 1 month, and 2 month follow-up
Geriatric Depression Scale Score (Center for Epidemiologic Studies-Depression Scale; CES-D)
Time frame: Baseline, 6 weeks (post), 1 month, and 2 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Per guidelines, we will publish deidentified data results from this trial via ClinicalTrials.gov within one year of study completion. Participants will be informed of this at the time of consent, if they are interested in learning the results from the study.
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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.
Lisa Kilpela, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binge Eating Syndrome Treatment (BESTOW) in people with Binge Eating, run by The University of Texas Health Science Center at San Antonio 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 6 inclusion and 4 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 7 Jan 2025. 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 7 Jan 2025). 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?
Feasibility - Usage Rating Profile - Intervention (time frame: 6 weeks (post), and 2 month follow-up). The study lists 2 primary outcomes in all. 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 7 Jan 2025.