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NCT03695289 · ClinicalTrials.gov registry record · NA

Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
30
Enrollment target

NCT03695289: Completed NA study, sponsored by Washington University School of Medicine.

NCT03695289 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03695289, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target

Study Summary

The proposed project aims to pilot and adapt a scalable and sustainable interactive obesity treatment approach (iOTA) program for adults with serious mental illness (SMI). The project consists of 2 arms: the iOTA SMI arm and the Health Education Control Group arm. The investigators hypothesize that participants in the iOTA intervention group will show favorable change in BMI compared to participants in the Health Education Control group, and participants in the iOTA intervention group will show favorable change in self efficacy with respect to healthy eating and activity compared to those in the Health Education Control group.

Primary Outcome

Weight in kilograms and height in meters will be measured and combined to calculate BMI in kg/mˆ2 at baseline and following 16 weeks of participation in either an Interactive Obesity Treatment Approach (iOTA) program or a Health Education Program.

Interventions

  • BEHAVIORAL Health Education Control
  • BEHAVIORAL iOTA SMI

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-07-05
Est. Completion 2020-06-25
Phase NA

What the finished NCT03695289 record still lists

NCT03695289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Health Education Control is the first listed.

NCT03695289 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03695289 about?

NCT03695289 is a clinical study titled "Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness". The proposed project aims to pilot and adapt a scalable and sustainable interactive obesity treatment approach (iOTA) program for adults with serious mental illness (SMI). The project consists of 2 arms: the iOTA SMI arm and the Health Education Control Group arm. The investigators hypothesize that ...

What is the current status of trial NCT03695289?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2018-07-05. Estimated completion is 2020-06-25.

What interventions are being tested in trial NCT03695289?

The interventions under investigation include: Health Education Control (BEHAVIORAL), iOTA SMI (BEHAVIORAL).

Who is sponsoring clinical trial NCT03695289?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03695289's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT03695289, the US trial registry maintained by the National Library of Medicine. NCT03695289 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.