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NCT04520256 · ClinicalTrials.gov registry record · Phase 2

Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

A Phase 2 study, sponsored by The Miriam Hospital.

Completed
Registry status
Phase 2
Development phase
384
Enrollment target

NCT04520256: Completed Phase 2 study, sponsored by The Miriam Hospital.

NCT04520256 is a Phase 2 study that has completed, run by The Miriam Hospital. The registered enrollment target is 384 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (189% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04520256, a Phase 2 study, has completed, sponsored by The Miriam Hospital.

COMPLETED
Registry status
Phase 2
Development phase
384 participants
Enrollment target

Study Summary

When delivered online, behavioral obesity treatments have the potential to reach large numbers of individuals with overweight/obesity and produce significant improvements in health and wellbeing. In order to maximize the public health benefit of disseminating these treatments online, this study will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, after a 12-month online behavioral obesity treatment.

Primary Outcome

Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight). A change between two time points is reported. The value of this outcome was calculated using: \[(baseline weight - month 12 weight) ÷ baseline weight\] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all ran

Interventions

  • BEHAVIORAL Online Behavioral Weight Loss Program
  • BEHAVIORAL Virtual Reality for Behavioral Weight Loss Skills Training
  • BEHAVIORAL Tailored Interactive Video Feedback
  • BEHAVIORAL Tailored Intervention for Structured Physical Activity
  • BEHAVIORAL Skills Training for Dysregulated Eating

Trial Details

FieldValue
Enrollment Target 384 participants
Start Date 2020-09-22
Est. Completion 2023-05-18
Phase Phase 2
The Miriam Hospital

136 total trials

What the finished NCT04520256 record still lists

NCT04520256 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (189% higher).

The record links to 0 conditions, and to 5 interventions - of which Online Behavioral Weight Loss Program is the first listed.

NCT04520256 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04520256 about?

NCT04520256 is a clinical study titled "Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy". When delivered online, behavioral obesity treatments have the potential to reach large numbers of individuals with overweight/obesity and produce significant improvements in health and wellbeing. In order to maximize the public health benefit of disseminating these treatments online, this study will...

What is the current status of trial NCT04520256?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 384 participants. The study started on 2020-09-22. Estimated completion is 2023-05-18.

What interventions are being tested in trial NCT04520256?

The interventions under investigation include: Online Behavioral Weight Loss Program (BEHAVIORAL), Virtual Reality for Behavioral Weight Loss Skills Training (BEHAVIORAL), Tailored Interactive Video Feedback (BEHAVIORAL), Tailored Intervention for Structured Physical Activity (BEHAVIORAL), Skills Training for Dysregulated Eating (BEHAVIORAL).

Who is sponsoring clinical trial NCT04520256?

This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04520256's enrollment target sits among peer trials

384 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT04520256, the US trial registry maintained by the National Library of Medicine. NCT04520256 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.