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Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness
NCT04560335 · View on ClinicalTrials.gov ↗
Study Summary
This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR\&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools. Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight
Conditions Studied
Interventions
- BEHAVIORAL Treatment as Usual
- BEHAVIORAL Coach to FIt
Study Locations (1)
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2021-08-02 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04560335
The ClinicalTrials.gov registry entry for NCT04560335 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 257 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Serious Mental Illness appearing as the primary indexed condition, and to 2 interventions — of which Treatment as Usual is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04560335 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04560335 about?
NCT04560335 is a clinical study titled "Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness". This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR\&D priority area...
What is the current status of trial NCT04560335?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 257 participants. The study started on 2021-08-02. Estimated completion is 2026-03-31.
What conditions does trial NCT04560335 study?
This clinical trial studies the following conditions: Serious Mental Illness. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04560335?
The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Coach to FIt (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04560335?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04560335 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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