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NCT04560335 · ClinicalTrials.gov registry record · NA
Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness
A NA study of Serious Mental Illness, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 257
- Enrollment target
- 1
- Study location
NCT04560335: Active NA study of Serious Mental Illness, sponsored by VA Office of Research and Development.
NCT04560335 is a NA study of Serious Mental Illness that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 257 participants, above the 104-participant average among 7 other Serious Mental Illness trials with a reported enrollment target (147% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560335, a NA study of Serious Mental Illness, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 257 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.
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 |
What the registry record for NCT04560335 still lists
NCT04560335 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 7 other Serious Mental Illness trials with a reported enrollment target (147% higher).
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.
NCT04560335 reports a single indexed study location in Pennsylvania.
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.
What interventions are being tested in trial NCT04560335?
The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Coach to FIt (BEHAVIORAL).
Who is sponsoring clinical trial NCT04560335?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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