ObesityPhase 3NCT00067145
Computer Intervention for Prevention of Weight Regain
A Phase 3 study testing Face-to-face maintenance program and Internet maintenance program in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Many overweight patients are able to lose weight successfully, but then regain their weight. The purpose of this study is to develop and test the efficacy of 2 interventions to prevent weight regain in individuals who have recently lost weight. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Face-to-face maintenance program and Internet maintenance program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
10% weight loss in past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Many overweight patients are able to lose weight successfully, but then regain their weight. The purpose of this study is to develop and test the efficacy of 2 interventions to prevent weight regain in individuals who have recently lost weight. The two interventions being tested are a face-to-face group maintenance program and an Internet intervention. These interventions will be compared to a no-contact control group that receives quarterly newsletters. The primary outcome measure is weight regain from baseline to 18-months.
- Conditions
- Obesity
- Being tested
- Face-to-face maintenance program, Internet maintenance program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face maintenance programBehavioural
Internet maintenance programBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067145
- Sponsor's protocol ID
- COMINTER (completed)
- Status last verified
- Jan 2010
- First submitted
- 11 Aug 2003
- Last updated
- 13 Jan 2010
- Results posted
- No
Publications
Wing RR, Tate DF, Gorin AA, Raynor HA, Fava JL. A self-regulation program for maintenance of weight loss. N Engl J Med. 2006 Oct 12;355(15):1563-71. doi: 10.1056/NEJMoa061883.
PubMed 17035649Marinilli Pinto A, Gorin AA, Raynor HA, Tate DF, Fava JL, Wing RR. Successful weight-loss maintenance in relation to method of weight loss. Obesity (Silver Spring). 2008 Nov;16(11):2456-61. doi: 10.1038/oby.2008.364. Epub 2008 Aug 14.
PubMed 18719680
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Intervention for Prevention of Weight Regain
- ClinicalTrials.gov ID
- NCT00067145
- Acronym / sponsor ID
- COMINTER (completed)
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- First posted
- 13 Aug 2003 (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.
Many overweight patients are able to lose weight successfully, but then regain their weight. The purpose of this study is to develop and test the efficacy of 2 interventions to prevent weight regain in individuals who have recently lost weight. The two interventions being tested are a face-to-face group maintenance program and an Internet intervention. These interventions will be compared to a no-contact control group that receives quarterly newsletters. The primary outcome measure is weight regain from baseline to 18-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 20 years and older
- 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 |
|---|---|---|
| Face-to-face maintenance program | Behavioural | – |
| Internet maintenance program | Behavioural | – |
Primary outcome
Not reported in the source record.
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 13 Jan 2010.
- Results publication: PubMed 17035649Wing RR, Tate DF, Gorin AA, Raynor HA, Fava JL. A self-regulation program for maintenance of weight loss. N Engl J Med. 2006 Oct 12;355(15):1563-71. doi: 10.1056/NEJMoa061883.
- Derived from this study: PubMed 18719680Marinilli Pinto A, Gorin AA, Raynor HA, Tate DF, Fava JL, Wing RR. Successful weight-loss maintenance in relation to method of weight loss. Obesity (Silver Spring). 2008 Nov;16(11):2456-61. doi: 10.1038/oby.2008.364. Epub 2008 Aug 14.
- Related InfoLink provided by the sponsor.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Face-to-face maintenance program and Internet maintenance program in people with Obesity, 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?
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 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067145, which also lists 2 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 13 Jan 2010.