Weight LossIWCRNCT04907396
International Weight Control Registry
An observational study of Weight Loss and Overweight, run by Tufts University at 7 sites in United States.
Trial summary
The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Overweight, Obesity
- How many people
- 100,000 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Dec 2020to 1 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 100,000 participants who meet eligibility requirements
Who may be able to join
- The IWCR is open to anyone 18 years or older who is considering weight loss, is actively engaged in weight loss, or has previously attempted weight loss (including successful and unsuccessful attempts)
Who cannot join
- Minors, below the age of 18
- Adults who are not able to give informed consent online and complete online surveys
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Frank Greenway, MD, frank.greenway@pbrc.edu
Frank Greenway, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
James E Friedman, MPH, (205) 962-8185, jfriedman@uabmc.edu
Drew Sayer, PhD, sayerd@uab.edu
- Recruiting
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
Jennifer L Oslund, MS, 702-468-2263, Jennifer.Oslund@tufts.edu
Susan B Roberts, PhD, 617-556-3238, susan.roberts@tufts.edu
- Recruiting
University of Colorado, Denver
Denver, Colorado, 80204
Ann E Caldwell, PhD, ann.caldwell@cuanschutz.edu
Ann E Caldwell, PhD
- Recruiting
University of New Hampshire
Durham, New Hampshire, 03824
Carlota Dao, PhD, carlota.dao@unh.edu
Carlota Dao, PhD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Anna M Gorczyca, PhD, agorczyca@ku.edu
Joseph Donnelly, E.D.D.
- Recruiting
United States Military Academy, West Point
West Point, New York, 10996
Diana M Thomas, PhD, diana.thomas@westpoint.edu
Diana M Thomas, PhD
About this study
The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight.
- Conditions
- Weight Loss, Overweight, Obesity
- Keywords
- Weight Loss Maintenance, Obesity Management
- Medical subject headings
- Weight Loss, Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight change
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start10 Dec 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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 Weight LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Colorado, Denver, University of Kansas Medical Center, Pennington Biomedical Research Center, University of New Hampshire, United States Military Academy West Point
- Responsible party
- Principal investigator, Susan Roberts, Tufts University
- Investigators
- Susan B Roberts, PhD, Principal investigator, Tufts UniversityJames O Hill, PhD, Principal investigator, University of Alabama at BirminghamSai K Das, PhD, Study director, Tufts UniversityDrew Sayer, PhD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907396
- Sponsor's protocol ID
- 13075
- Acronym
- IWCR
- Status last verified
- Sep 2024
- First submitted
- 25 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared. Specific to be determined
Publications
Chui TK, Cedillo YE, El Zein A, Pavela G, Caldwell AE, Peters JC, Friedman JE, DebRoy S, Oslund JL, Das SK, Roberts SB, Hill JO, Sayer RD. Evaluation of socioecological factors on health behaviors and weight change during major life event: A cross-sectional study using data collected during the COVID-19 pandemic. Obes Sci Pract. 2024 Aug 10;10(4):e785. doi: 10.1002/osp4.785. eCollection 2024 Aug.
PubMed 39130192Caldwell AE, More KR, Chui TK, Sayer RD. Psychometric validation of four-item exercise identity and healthy-eater identity scales and applications in weight loss maintenance. Int J Behav Nutr Phys Act. 2024 Feb 23;21(1):21. doi: 10.1186/s12966-024-01573-y.
PubMed 38395833Roberts SB, Das SK, Sayer RD, Caldwell AE, Wyatt HR, Mehta TS, Gorczyca AM, Oslund JL, Peters JC, Friedman JE, Chiu CY, Greenway FL, Donnelly JE, Dao MC, Cuevas AG, Affuso O, Wilkinson LL, Thomas D, Al-Ozairi E, Yannakoulia M, Khazrai YM, Manalac RJ, Bachiashvili V, Hill JO. Technical report: an online international weight control registry to inform precision approaches to healthy weight management. Int J Obes (Lond). 2022 Sep;46(9):1728-1733. doi: 10.1038/s41366-022-01158-4. Epub 2022 Jun 16.
PubMed 35710944
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Weight Control Registry
- ClinicalTrials.gov ID
- NCT04907396
- Acronym / sponsor ID
- IWCR / 13075
- Conditions
- Weight Loss, Overweight, Obesity
- Keywords
- Weight Loss Maintenance, Obesity Management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Colorado, Denver, University of Kansas Medical Center, Pennington Biomedical Research Center, University of New Hampshire, United States Military Academy West Point
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 May 2021 (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 IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100,000 participants who meet eligibility requirements
Key inclusion criteria (1 listed)
- The IWCR is open to anyone 18 years or older who is considering weight loss, is actively engaged in weight loss, or has previously attempted weight loss (including successful and unsuccessful attempts)
Key exclusion criteria (2 listed)
- Minors, below the age of 18
- Adults who are not able to give informed consent online and complete online surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent weight change
Time frame: 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39130192Chui TK, Cedillo YE, El Zein A, Pavela G, Caldwell AE, Peters JC, Friedman JE, DebRoy S, Oslund JL, Das SK, Roberts SB, Hill JO, Sayer RD. Evaluation of socioecological factors on health behaviors and weight change during major life event: A cross-sectional study using data collected during the COVID-19 pandemic. Obes Sci Pract. 2024 Aug 10;10(4):e785. doi: 10.1002/osp4.785. eCollection 2024 Aug.
- Derived from this study: PubMed 38395833Caldwell AE, More KR, Chui TK, Sayer RD. Psychometric validation of four-item exercise identity and healthy-eater identity scales and applications in weight loss maintenance. Int J Behav Nutr Phys Act. 2024 Feb 23;21(1):21. doi: 10.1186/s12966-024-01573-y.
- Derived from this study: PubMed 35710944Roberts SB, Das SK, Sayer RD, Caldwell AE, Wyatt HR, Mehta TS, Gorczyca AM, Oslund JL, Peters JC, Friedman JE, Chiu CY, Greenway FL, Donnelly JE, Dao MC, Cuevas AG, Affuso O, Wilkinson LL, Thomas D, Al-Ozairi E, Yannakoulia M, Khazrai YM, Manalac RJ, Bachiashvili V, Hill JO. Technical report: an online international weight control registry to inform precision approaches to healthy weight management. Int J Obes (Lond). 2022 Sep;46(9):1728-1733. doi: 10.1038/s41366-022-01158-4. Epub 2022 Jun 16.
- International Weight Control Registry WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data will be shared. Specific to be determined
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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.
Susan B Roberts, PhD principal investigator
Tufts University
James O Hill, PhD principal investigator
University of Alabama at Birmingham
Sai K Das, PhD study director
Tufts University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Overweight, run by Tufts University at 7 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 1 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Contact James E Friedman, MPH (205-962-8185, jfriedman@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight change (time frame: 5 Years). 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 NCT04907396, 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 19 Sep 2024; AzTrials last refreshed its copy on 28 Oct 2026.