Binge Eating/Loss of Control EatingNCT01395355
An Integrative Intervention for Loss of Control Eating Among Adolescent Girls
A study testing Linking Individuals Being Emotionally Real (LIBER8) in people with Binge Eating/Loss of Control Eating, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study aims to develop a manualized and culturally sensitive intervention for adolescent girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the feasibility and acceptability of the intervention in a controlled pilot trial. Read more about this study
- Who is it for?
- Ages 13 to 22 years, women only
- Conditions the study is for
- Binge Eating/Loss of Control Eating
- What is being tested?
- Linking Individuals Being Emotionally Real (LIBER8)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2014
- 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 13 to 22 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- currently meeting criteria for loss of control (LOC) eating or binge eating disorder (BED) as defined by Marcus and Kalarchian
- age 13-22
- female
- lives with parent/primary caregiver most of the time
Who cannot join
- alcohol or drug dependence in the last three months
- current suicidal intent or clinically significant self-harm behaviors reported during the assessment
- diagnosis of bulimia nervosa or anorexia nervosa in the last three months
- presence of a developmental disability or neurological impairment that would impair the individual's ability to participate in the intervention
- psychosis, including schizophrenia, or bipolar I disorder
- not fluent in English (participant and parents/primary caregivers
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
Official title: An Integrative Intervention for Binge Eating Among Adolescent Girls
This study aims to develop a manualized and culturally sensitive intervention for adolescent girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the feasibility and acceptability of the intervention in a controlled pilot trial. The investigators hypothesize that this intervention will serve to reduce binge and LOC eating, as well as improve psychosocial functioning as evidenced by decreased depression, anxiety, eating disorder cognitions, and impulsivity, and improved quality of life.
- Conditions
- Binge Eating/Loss of Control Eating
- Being tested
- Linking Individuals Being Emotionally Real (LIBER8), Weight Management Control
- Keywords
- binge eating, loss of control eating, eating in the absence of hunger, emotional eating
- Medical subject headings
- Bulimia, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linking Individuals Being Emotionally Real (LIBER8)Behavioural
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
Weight Management ControlBehavioural
Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral techniques.
| Study group | Role | What they receive |
|---|---|---|
| Linking Individuals Being Emotionally Real (LIBER8) | Experimental | Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques. Receives: Behavioral: Linking Individuals Being Emotionally Real (LIBER8) |
| Weight Management Control | Active comparator | Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral weight management techniques. Receives: Behavioral: Weight Management Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up
Measured: 3-Month Follow-up
Secondary outcomes (9)
Changes in eating disorder cognitions (e.g., eating, weight and shape concern, restrain) from baseline to three month follow-up.
Measured: 3-Month Follow-up
Changes in depressive symptoms from baseline to three month follow-up.
Measured: 3-Month Follow-up
Changes in anxiety symptoms from baseline to three month follow-up.
Measured: 3-Month Follow-up
Changes in health-related quality of life (including social, emotional, school, and physical functioning) from baseline to three month follow-up.
Measured: 3-Month Follow-up
Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.
Measured: 3-Month Follow-up
Changes in impulsive behaviors from baseline to three month follow-up.
Measured: 3-Month Follow-up
Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.
Measured: 3-Month Follow-up
Height and Weight
Measured: 3-Month Follow-up
Changes in the frequency of eating as a means of coping with negative emotions, such as anger, sadness and anxiety, from baseline to three month follow-up.
Measured: 3-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 posted15 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge Eating/Loss of Control EatingStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne E Mazzeo, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395355
- Sponsor's protocol ID
- 1R34MH086922-01A2
- Other IDs
- 1R34MH086922-01A2
- Status last verified
- May 2015
- First submitted
- 30 Jun 2011
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palmberg AA, Stern M, Kelly NR, Bulik C, Belgrave FZ, Trapp SK, Hofmeier SM, Mazzeo SE. Adolescent Girls and Their Mothers Talk About Experiences of Binge and Loss of Control Eating. J Child Fam Stud. 2014 Nov;23(8):1403-1416. doi: 10.1007/s10826-013-9797-z.
PubMed 25400491Mazzeo SE, Kelly NR, Stern M, Palmberg AA, Belgrave FZ, Tanofsky-Kraff M, Latzer Y, Bulik CM. LIBER8 design and methods: an integrative intervention for loss of control eating among African American and White adolescent girls. Contemp Clin Trials. 2013 Jan;34(1):174-85. doi: 10.1016/j.cct.2012.10.012. Epub 2012 Nov 9.
PubMed 23142669Mazzeo SE, Lydecker J, Harney M, Palmberg AA, Kelly NR, Gow RW, Bean MK, Thornton LM, Tanofsky-Kraff M, Bulik CM, Latzer Y, Stern M. Development and preliminary effectiveness of an innovative treatment for binge eating in racially diverse adolescent girls. Eat Behav. 2016 Aug;22:199-205. doi: 10.1016/j.eatbeh.2016.06.014. Epub 2016 Jun 3.
PubMed 27299699
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Intervention for Binge Eating Among Adolescent Girls
- ClinicalTrials.gov ID
- NCT01395355
- Acronym / sponsor ID
- 1R34MH086922-01A2
- Conditions
- Binge Eating/Loss of Control Eating
- Keywords
- binge eating, loss of control eating, eating in the absence of hunger, emotional eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH)
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jul 2011 (estimated)
- 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.
This study aims to develop a manualized and culturally sensitive intervention for adolescent girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the feasibility and acceptability of the intervention in a controlled pilot trial. The investigators hypothesize that this intervention will serve to reduce binge and LOC eating, as well as improve psychosocial functioning as evidenced by decreased depression, anxiety, eating disorder cognitions, and impulsivity, and improved quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linking Individuals Being Emotionally Real (LIBER8) | Experimental | Behavioral: Linking Individuals Being Emotionally Real (LIBER8)Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques. |
| Weight Management Control | Active comparator | Behavioral: Weight Management ControlParticipants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral weight management techniques. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- currently meeting criteria for loss of control (LOC) eating or binge eating disorder (BED) as defined by Marcus and Kalarchian
- age 13-22
- female
- lives with parent/primary caregiver most of the time
Key exclusion criteria (6 listed)
- alcohol or drug dependence in the last three months
- current suicidal intent or clinically significant self-harm behaviors reported during the assessment
- diagnosis of bulimia nervosa or anorexia nervosa in the last three months
- presence of a developmental disability or neurological impairment that would impair the individual's ability to participate in the intervention
- psychosis, including schizophrenia, or bipolar I disorder
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 |
|---|---|---|
| Linking Individuals Being Emotionally Real (LIBER8)Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques. | Behavioural | Linking Individuals Being Emotionally Real (LIBER8) |
| Weight Management ControlParticipants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral techniques. | Behavioural | Weight Management Control |
Primary outcome
Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up
Time frame: 3-Month Follow-up
9 secondary outcomes
Changes in eating disorder cognitions (e.g., eating, weight and shape concern, restrain) from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Changes in depressive symptoms from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Changes in anxiety symptoms from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Changes in health-related quality of life (including social, emotional, school, and physical functioning) from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Changes in impulsive behaviors from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Height and Weight
Time frame: 3-Month Follow-up
Changes in the frequency of eating as a means of coping with negative emotions, such as anger, sadness and anxiety, from baseline to three month follow-up.
Time frame: 3-Month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Background: PubMed 25400491Palmberg AA, Stern M, Kelly NR, Bulik C, Belgrave FZ, Trapp SK, Hofmeier SM, Mazzeo SE. Adolescent Girls and Their Mothers Talk About Experiences of Binge and Loss of Control Eating. J Child Fam Stud. 2014 Nov;23(8):1403-1416. doi: 10.1007/s10826-013-9797-z.
- Background: PubMed 23142669Mazzeo SE, Kelly NR, Stern M, Palmberg AA, Belgrave FZ, Tanofsky-Kraff M, Latzer Y, Bulik CM. LIBER8 design and methods: an integrative intervention for loss of control eating among African American and White adolescent girls. Contemp Clin Trials. 2013 Jan;34(1):174-85. doi: 10.1016/j.cct.2012.10.012. Epub 2012 Nov 9.
- Derived from this study: PubMed 27299699Mazzeo SE, Lydecker J, Harney M, Palmberg AA, Kelly NR, Gow RW, Bean MK, Thornton LM, Tanofsky-Kraff M, Bulik CM, Latzer Y, Stern M. Development and preliminary effectiveness of an innovative treatment for binge eating in racially diverse adolescent girls. Eat Behav. 2016 Aug;22:199-205. doi: 10.1016/j.eatbeh.2016.06.014. Epub 2016 Jun 3.
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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.
Suzanne E Mazzeo, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linking Individuals Being Emotionally Real (LIBER8) in people with Binge Eating/Loss of Control Eating, run by Virginia Commonwealth 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 4 inclusion and 6 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 8 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up (time frame: 3-Month Follow-up). 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 NCT01395355, which also lists 3 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 8 May 2015.