International Weight Control Registry | NCT04907396

Studies
International Weight Control Registry

NCT04907396

Sponsor

Tufts University

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Weight Loss
Overweight
Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2020Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

May 25, 2021

First Posted Date

May 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susan Roberts, Co-Principal Investigator, Tufts UniversityPrincipal Investigator

Lead Sponsor

Tufts UniversityOTHER

Collaborators

Name	Class
University of Alabama at Birmingham	OTHER
University of Colorado, Denver	OTHER
University of Kansas Medical Center	OTHER
Pennington Biomedical Research Center

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100,000Estimated

Measure	Description	Time Frame
Percent weight change		5 Years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Minors, below the age of 18
Adults who are not able to give informed consent online and complete online surveys

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Up to 100,000 participants who meet eligibility requirements

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
James E Friedman, MPH	Contact	205-962-8185		jfriedman@uabmc.edu
Jennifer L Oslund, MS	Contact	702-468-2263		Jennifer.Oslund@tufts.edu

Overall Officials

Name	Affiliation	Role
Susan B Roberts, PhD	Tufts University	Principal Investigator
James O Hill, PhD	University of Alabama at Birmingham	Principal Investigator
Sai K Das, PhD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham	Recruiting	Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39130192	Derived	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.
38395833

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D015431	Weight Loss
D050177	Overweight
D009765	Obesity