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NCT05861973 · ClinicalTrials.gov registry record · NA

SMARTer Weight Loss Management

A NA study of Obesity, sponsored by Northwestern University.

Recruiting
Registry status
NA
Development phase
492
Enrollment target
1
Study location

NCT05861973 is a NA study of Obesity that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 492 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05861973, a NA study of Obesity, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
NA
Development phase
492 participants
Enrollment target
1
Study location

Study Summary

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

Conditions Studied

Interventions

  • BEHAVIORAL Adaptive SMARTer intervention (SMARTer)
  • BEHAVIORAL Diabetes Prevention Program (DPP)
  • BEHAVIORAL Self-Guided Treatment (Self-Guided)

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 492 participants
Start Date 2024-06-25
Est. Completion 2028-01-01
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT05861973

The ClinicalTrials.gov registry entry for NCT05861973 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 492 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (40% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Adaptive SMARTer intervention (SMARTer) is the first listed.

NCT05861973 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT05861973 about?

NCT05861973 is a clinical study titled "SMARTer Weight Loss Management". The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving com...

What is the current status of trial NCT05861973?

This trial is currently recruiting. It is a NA study. The enrollment target is 492 participants. The study started on 2024-06-25. Estimated completion is 2028-01-01.

What conditions does trial NCT05861973 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT05861973?

The interventions under investigation include: Adaptive SMARTer intervention (SMARTer) (BEHAVIORAL), Diabetes Prevention Program (DPP) (BEHAVIORAL), Self-Guided Treatment (Self-Guided) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05861973?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05861973 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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