ObesityPhase 1NCT00125112
Internet Weight Control for Bingeing Adolescents
A Phase 1 study testing Internet-based intervention designed to reduce binge eating and improve healthy weight regulation in people with Obesity and Eating Disorders, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Disorders
- What is being tested?
- Internet-based intervention designed to reduce binge eating and improve healthy weight regulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2007
- Phase
- Phase 1
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female and male high school students in Hayward Unified School District or Meridian School District
- 85th or greater percentile for age-adjusted weight
- Objective binge eating one or more times weekly for a duration of ≥ 3 months
- Access to a computer with internet access
- English literacy at a sixth grade reading level
Who cannot join
- Current (or history of) diagnosis of anorexia or bulimia nervosa
- Active suicidal ideation
- Current enrollment in a formal weight loss or binge eating program (e.g., Weight Watchers)
- Any medical condition in which the actual condition or treatment affects weight and/or appetite (i.e., cancer, diabetes)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Department of Psychiatry and Behavioral Sciences
Stanford, California, 94305-5722
About this study
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.
Read the detailed description
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.
- Conditions
- Obesity, Eating Disorders
- Being tested
- Internet-based intervention designed to reduce binge eating and improve healthy weight regulation
- Keywords
- binge eating, weight loss, obesity
- Medical subject headings
- Obesity, Feeding and Eating Disorders, Bulimia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based intervention designed to reduce binge eating and improve healthy weight regulationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of binge eating; weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startFeb 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- C. Barr Taylor, M.D., Principal investigator, Stanford University Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125112
- Sponsor's protocol ID
- DK65757 (completed)
- Status last verified
- Jan 2010
- First submitted
- 28 Jul 2005
- Last updated
- 18 Jan 2010
- Results posted
- No
Publications
Jones M, Luce KH, Osborne MI, Taylor K, Cunning D, Doyle AC, Wilfley DE, Taylor CB. Randomized, controlled trial of an internet-facilitated intervention for reducing binge eating and overweight in adolescents. Pediatrics. 2008 Mar;121(3):453-62. doi: 10.1542/peds.2007-1173.
PubMed 18310192
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Weight Control for Bingeing Adolescents
- ClinicalTrials.gov ID
- NCT00125112
- Acronym / sponsor ID
- DK65757 (completed)
- Conditions
- Obesity, Eating Disorders
- Keywords
- binge eating, weight loss, obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Feb 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Jul 2005 (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.
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.
Detailed description
The purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female and male high school students in Hayward Unified School District or Meridian School District
- 85th or greater percentile for age-adjusted weight
- Objective binge eating one or more times weekly for a duration of ≥ 3 months
- Access to a computer with internet access
- English literacy at a sixth grade reading level
Key exclusion criteria (4 listed)
- Current (or history of) diagnosis of anorexia or bulimia nervosa
- Active suicidal ideation
- Current enrollment in a formal weight loss or binge eating program (e.g., Weight Watchers)
- Any medical condition in which the actual condition or treatment affects weight and/or appetite (i.e., cancer, diabetes)
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 |
|---|---|---|
| Internet-based intervention designed to reduce binge eating and improve healthy weight regulation | Behavioural | – |
Primary outcome
Frequency of binge eating; weight
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 18 Jan 2010.
- Derived from this study: PubMed 18310192Jones M, Luce KH, Osborne MI, Taylor K, Cunning D, Doyle AC, Wilfley DE, Taylor CB. Randomized, controlled trial of an internet-facilitated intervention for reducing binge eating and overweight in adolescents. Pediatrics. 2008 Mar;121(3):453-62. doi: 10.1542/peds.2007-1173.
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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.
C. Barr Taylor, M.D. principal investigator
Stanford University Department of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Internet-based intervention designed to reduce binge eating and improve healthy weight regulation in people with Obesity and Eating Disorders, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 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 18 Jan 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of binge eating; weight. 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 NCT00125112, which also lists 1 linked publication.
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 18 Jan 2010.