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New app helps people with mental illness shed pounds

NCT ID NCT04560335

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a weight-loss program called CoachToFit for 257 veterans with serious mental illness (like schizophrenia or bipolar disorder) who were obese. Participants used a smartphone app, an activity tracker, and a Bluetooth scale, and worked with a peer coach. The goal was to see if this approach could help them lose weight and improve fitness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CoachToFit app, activity tracker, and Bluetooth scale
What this could lead to
If successful, this program could offer a practical, low-cost way to help people with serious mental illness lose weight and improve their health.
What could go wrong
This is a completed study, but results may not apply to all groups. Weight loss can be hard to maintain long-term, and the program requires a smartphone and motivation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

257 people

The number who actually took part.

Started

Aug 2021

Finished

Mar 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis; * age 18 and over; * BMI \>= 30.0 (obese); and * ownership of a phone running Android OS or iOS (iPhone). Exclusion Criteria: * chart diagnosis of dementia; * history of bariatric surgery; * pregnant and nursing mothers; * patient has a conservator/legally authorized representative who makes their medical decisions; * psychiatric hospitalization during the month prior to enrollment. Additionally, we will follow the American College of Sports Medicine recommendations for health screening and risk stratification in preparation for starting a moderate intensity exercise program to ensure that participants enrolled are capable of safely engaging in the app's recommendations regarding physical activity. Specifically, all potential participants will be given the Physical Activity Readiness Questionnaire (PAR-Q), a screening tool often used in weight management trials. If they endorse symptoms or major signs suggestive of cardiopulmonary disease (i.e., angina, anginal equivalent, dyspnea, syncope, orthopnea, edema, palpitations or claudication), which is a score \>=1 on the PAR-Q, they will need clearance from a VA physician before enrolling.

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Conditions

The condition(s) this trial relates to.

bipolar disorder major depressive disorder Motor Activity psychiatric disorder schizoaffective disorder schizophrenia Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Serious mental illness

Contacts and locations

Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.