Binge EatingBE-sideNCT06495619
Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity
A study testing treatment-as-usual, combined TAU and guided self-help and combined TAU, GSH, and biofeedback in people with Binge Eating and Overweight and Obesity, run by G. d'Annunzio University.
Trial summary
The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE): 1. treatment-as-usual for weight loss (TAU); 2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH); 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating, Overweight and Obesity
- What is being tested?
- treatment-as-usual, combined TAU and guided self-help and combined TAU, GSH, and biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jun 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:(1) age 18-65 years; (2) BMI≥25 kg/m2; (3) ability to read and write in Italian; (4) Binge Eating Disorder (BED) or subthreshold BED status.
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Exclusion Criteria: (1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity.
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Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity: A Multidisciplinary Approach
The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE):
- treatment-as-usual for weight loss (TAU);
- combined TAU and guided self-help for improving eating behaviors (TAU+GSH);
- combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).
Read more
The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers.
The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.
- Conditions
- Binge Eating, Overweight and Obesity
- Being tested
- treatment-as-usual, combined TAU and guided self-help, combined TAU, GSH, and biofeedback
- Keywords
- Binge Eating, Overweight, Obesity, Guided Self-Help, Biofeedback
- Medical subject headings
- Bulimia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment-as-usualBehavioural
Also called TAU
life style modification intervention for weight loss
combined TAU and guided self-helpBehavioural
Also called TAU+GSH
combined TAU and guided self-help for improving eating behaviors
combined TAU, GSH, and biofeedbackBehavioural
Also called TAU+GSH+BF
combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation
| Study group | Role | What they receive |
|---|---|---|
| (1)TAU | Active comparator | treatment-as-usual for weight loss (TAU) Receives: Behavioral: treatment-as-usual |
| (2)TAU+GSH | Active comparator | combined TAU and guided self-help for improving eating behaviors (TAU+GSH) Receives: Behavioral: combined TAU and guided self-help |
| (3)TAU+GSH+BF | Active comparator | combined TAU, GSH, and biofeedback (TAU+GSH+BF) Receives: Behavioral: combined TAU, GSH, and biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective BE episodes (OBEs)
The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)
Measured: 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)
Secondary outcomes (3)
psychological variables
The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress.
Measured: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
physiological correlates of arousal
The secondary outcomes will be skin conductance and heart rate variability.
Measured: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
inflammatory biomarkers
The secondary outcomes will be ClpB protein and IgG
Measured: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Binge EatingStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIARA CONTI, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495619
- Sponsor's protocol ID
- Prot. n. 254
- Acronym
- BE-side
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets generated during and/or analysed during the current study are available from the PI on reasonable request.
Publications
de Zwaan M, Herpertz S, Zipfel S, Tuschen-Caffier B, Friederich HC, Schmidt F, Gefeller O, Mayr A, Lam T, Schade-Brittinger C, Hilbert A. INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial. Trials. 2012 Nov 21;13:220. doi: 10.1186/1745-6215-13-220.
PubMed 23171536DiMarco ID, Klein DA, Clark VL, Wilson GT. The use of motivational interviewing techniques to enhance the efficacy of guided self-help behavioral weight loss treatment. Eat Behav. 2009 Apr;10(2):134-6. doi: 10.1016/j.eatbeh.2009.02.001. Epub 2009 Feb 15.
PubMed 19447358Mueller J, Richards R, Jones RA, Whittle F, Woolston J, Stubbings M, Sharp SJ, Griffin SJ, Bostock J, Hughes CA, Hill AJ, Boothby CE, Ahern AL. Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention. Int J Obes (Lond). 2023 Jan;47(1):51-59. doi: 10.1038/s41366-022-01232-x. Epub 2022 Nov 11.
PubMed 36369513Varela C, Oda-Montecinos C, Andres A, Saldana C. Effectiveness of web-based feedback interventions for people with overweight and obesity: systematic review and network meta-analysis of randomized controlled trials. J Eat Disord. 2021 Jun 26;9(1):75. doi: 10.1186/s40337-021-00432-6.
PubMed 34174949de Zwaan M, Herpertz S, Zipfel S, Svaldi J, Friederich HC, Schmidt F, Mayr A, Lam T, Schade-Brittinger C, Hilbert A. Effect of Internet-Based Guided Self-help vs Individual Face-to-Face Treatment on Full or Subsyndromal Binge Eating Disorder in Overweight or Obese Patients: The INTERBED Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):987-995. doi: 10.1001/jamapsychiatry.2017.2150.
PubMed 28768334Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.
PubMed 22477926
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity: A Multidisciplinary Approach
- ClinicalTrials.gov ID
- NCT06495619
- Acronym / sponsor ID
- BE-side / Prot. n. 254
- Conditions
- Binge Eating, Overweight and Obesity
- Keywords
- Binge Eating, Overweight, Obesity, Guided Self-Help, Biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Jul 2024 (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 main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE):
- treatment-as-usual for weight loss (TAU);
- combined TAU and guided self-help for improving eating behaviors (TAU+GSH);
- combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).
The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers.
The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (1)TAU | Active comparator | Behavioral: treatment-as-usualtreatment-as-usual for weight loss (TAU) |
| (2)TAU+GSH | Active comparator | Behavioral: combined TAU and guided self-helpcombined TAU and guided self-help for improving eating behaviors (TAU+GSH) |
| (3)TAU+GSH+BF | Active comparator | Behavioral: combined TAU, GSH, and biofeedbackcombined TAU, GSH, and biofeedback (TAU+GSH+BF) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| treatment-as-usualAlso: TAUlife style modification intervention for weight loss | Behavioural | (1)TAU |
| combined TAU and guided self-helpAlso: TAU+GSHcombined TAU and guided self-help for improving eating behaviors | Behavioural | (2)TAU+GSH |
| combined TAU, GSH, and biofeedbackAlso: TAU+GSH+BFcombined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation | Behavioural | (3)TAU+GSH+BF |
Primary outcome
objective BE episodes (OBEs)
Time frame: 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)
The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)
3 secondary outcomes
psychological variables
Time frame: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
physiological correlates of arousal
Time frame: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
inflammatory biomarkers
Time frame: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 23171536de Zwaan M, Herpertz S, Zipfel S, Tuschen-Caffier B, Friederich HC, Schmidt F, Gefeller O, Mayr A, Lam T, Schade-Brittinger C, Hilbert A. INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial. Trials. 2012 Nov 21;13:220. doi: 10.1186/1745-6215-13-220.
- Background: PubMed 19447358DiMarco ID, Klein DA, Clark VL, Wilson GT. The use of motivational interviewing techniques to enhance the efficacy of guided self-help behavioral weight loss treatment. Eat Behav. 2009 Apr;10(2):134-6. doi: 10.1016/j.eatbeh.2009.02.001. Epub 2009 Feb 15.
- Background: PubMed 36369513Mueller J, Richards R, Jones RA, Whittle F, Woolston J, Stubbings M, Sharp SJ, Griffin SJ, Bostock J, Hughes CA, Hill AJ, Boothby CE, Ahern AL. Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention. Int J Obes (Lond). 2023 Jan;47(1):51-59. doi: 10.1038/s41366-022-01232-x. Epub 2022 Nov 11.
- Background: PubMed 34174949Varela C, Oda-Montecinos C, Andres A, Saldana C. Effectiveness of web-based feedback interventions for people with overweight and obesity: systematic review and network meta-analysis of randomized controlled trials. J Eat Disord. 2021 Jun 26;9(1):75. doi: 10.1186/s40337-021-00432-6.
- Background: PubMed 28768334de Zwaan M, Herpertz S, Zipfel S, Svaldi J, Friederich HC, Schmidt F, Mayr A, Lam T, Schade-Brittinger C, Hilbert A. Effect of Internet-Based Guided Self-help vs Individual Face-to-Face Treatment on Full or Subsyndromal Binge Eating Disorder in Overweight or Obese Patients: The INTERBED Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):987-995. doi: 10.1001/jamapsychiatry.2017.2150.
- Background: PubMed 22477926Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.
- Individual participant dataSharing planned: No. The data sets generated during and/or analysed during the current study are available from the PI on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing treatment-as-usual, combined TAU and guided self-help and combined TAU, GSH, and biofeedback in people with Binge Eating and Overweight and Obesity, run by G. d'Annunzio University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Jul 2024. 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?
Contact CHIARA CONTI, PhD (+3908713555338, cconti@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective BE episodes (OBEs) (time frame: 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06495619, which also lists 6 linked publications.
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 11 Jul 2024.