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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: Recruiting NA study of Obesity, sponsored by Northwestern University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Participant percent change in weight (kg) from baseline to 6-months.

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
Northwestern University

1,209 total trials

What NCT05861973 shows while recruiting

NCT05861973 is an interventional study that assigns participants to a tested intervention. The registered 492 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (40% lower).

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 a single indexed study location in 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.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05861973's enrollment target sits among peer trials

492 144th of 1053 higher than 910 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05861973, the US trial registry maintained by the National Library of Medicine. NCT05861973 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.