ObesityBEST4USNCT01888406
Binge Eating Self-help Treatment for University Students
A study testing Guided Self-Help and Pure Self-Help in people with Obesity and Binge Eating Disorder, run by Francine Rosselli at 2 sites in United States.
Trial summary
BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Binge Eating Disorder
- What is being tested?
- Guided Self-Help and Pure Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Sep 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 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- binge eating episodes at least once per week in the past 28 days
- 18 to 22 years old
- full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)
Who cannot join
- purging more than once per week in the past three months
- BMI less than 18 or greater than/equal to 40
- currently pregnant
- severe depressive symptoms or suicidality
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Manchester Community College Department of Psychology
Manchester, Connecticut, 06040
Wesleyan University Department of Psychology
Middletown, Connecticut, 06459
About this study
Official title: Targeting Binge Eating to Prevent Weight Gain in College Students
BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. The two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.
- Conditions
- Obesity, Binge Eating Disorder
- Being tested
- Guided Self-Help, Pure Self-Help
- Keywords
- Obesity, Weight gain prevention, Eating disorder, Binge eating
- Medical subject headings
- Obesity, Binge-Eating Disorder, Feeding and Eating Disorders, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-HelpBehavioural
Pure Self-HelpBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Guided Self-Help | Experimental | Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources. In addition, participants receive 8 individual sessions with a peer coach who supports participants in working the self-help program. Receives: Behavioral: Guided Self-Help |
| Pure Self-Help | Other | Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources. Receives: Behavioral: Pure Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
The primary outcome measure is change in BMI from randomization. Height and weight will be measured by study staff at the baseline visit using a stadiometer (collecting height measures twice and reporting the average) and a calibrated scale (light clothing, street shoes removed). BMI will be calculated as weight in kilograms divided by height in squared centimeters. Weight will be re-measured at 8 week- and 6 month assessments. BMI change is a primary-, and incidence of obesity (i.e., obesity onset since baseline, BMI > 30) is a secondary outcome variable. While we assess weight at the post-treatment assessment, the key question of our study is whether the intervention will reduce excess weight gain at 6-month follow-up.
Measured: Baseline, post-intervention (8-week), and 6-month follow-up
Secondary outcomes (1)
Cessation of Binge Eating
Binge eating is assessed by clinical interview using an abbreviated version of the Eating Disorders Examination (EDE-16e) at baseline, post-treatment (8-week), and 6-month follow-up. Specifically, the EDE sections on 7-day meal patterns, overeating episodes, and the frequency of inappropriate compensatory behaviors will be administered. The key question of our study is whether the intervention will eliminate binge eating at 6-month follow-up (no reported binge eating episodes in the 28 days prior to the 6-month follow-up).
Measured: Baseline, post-intervention (8-week), and 6-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 posted27 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francine Rosselli
- Sponsor type
- University, hospital or other
- Collaborators
- Wesleyan University
- Responsible party
- Sponsor-investigator, Francine Rosselli, Wesleyan University
- Investigators
- Ruth Striegel, PhD, Principal investigator, Wesleyan UniversityFrancine Rosselli, PhD, Study director, Manchester Community College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888406
- Sponsor's protocol ID
- 1R15DK092768-O1A1
- Other IDs
- 1R15DK092768
- Acronym
- BEST4US
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Binge Eating to Prevent Weight Gain in College Students
- ClinicalTrials.gov ID
- NCT01888406
- Acronym / sponsor ID
- BEST4US / 1R15DK092768-O1A1
- Conditions
- Obesity, Binge Eating Disorder
- Keywords
- Obesity, Weight gain prevention, Eating disorder, Binge eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Francine RosselliUniversity, hospital or other
- Collaborators
- Wesleyan University
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 27 Jun 2013 (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.
BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. The two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Self-Help | Experimental | Behavioral: Guided Self-HelpParticipants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources. In addition, participants receive 8 individual sessions with a peer coach who supports participants in working the self-help program. |
| Pure Self-Help | Other | Behavioral: Pure Self-HelpParticipants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- binge eating episodes at least once per week in the past 28 days
- 18 to 22 years old
- full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)
Key exclusion criteria (4 listed)
- purging more than once per week in the past three months
- BMI less than 18 or greater than/equal to 40
- currently pregnant
- severe depressive symptoms or suicidality
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 |
|---|---|---|
| Guided Self-Help | Behavioural | Guided Self-Help |
| Pure Self-Help | Behavioural | Pure Self-Help |
Primary outcome
BMI
Time frame: Baseline, post-intervention (8-week), and 6-month follow-up
The primary outcome measure is change in BMI from randomization. Height and weight will be measured by study staff at the baseline visit using a stadiometer (collecting height measures twice and reporting the average) and a calibrated scale (light clothing, street shoes removed). BMI will be calculated as weight in kilograms divided by height in squared centimeters. Weight will be re-measured at 8 week- and 6 month assessments. BMI change is a primary-, and incidence of obesity (i.e., obesity onset since baseline, BMI > 30) is a secondary outcome variable. While we assess weight at the post-treatment assessment, the key question of our study is whether the intervention will reduce excess weight gain at 6-month follow-up.
1 secondary outcome
Cessation of Binge Eating
Time frame: Baseline, post-intervention (8-week), and 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Ruth Striegel, PhD principal investigator
Wesleyan University
Francine Rosselli, PhD study director
Manchester Community College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Help and Pure Self-Help in people with Obesity and Binge Eating Disorder, run by Francine Rosselli at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
BMI (time frame: Baseline, post-intervention (8-week), and 6-month follow-up). 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 27 Jun 2013.