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Phone therapy shows promise for weight loss in new study

NCT ID NCT04447313

Disease control Sponsor: Fred Hutchinson Cancer Center 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase III trial tests whether telephone-based Acceptance and Commitment Therapy (ACT) helps overweight or obese adults lose more weight than standard behavioral therapy. About 418 participants will receive coaching over the phone and use a Fitbit and scale to track progress. The study aims to see which approach leads to at least 10% weight loss.

What this could mean

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

Active substance
Telephone-based coaching (Acceptance and Commitment Therapy or standard behavioral therapy)
What this could lead to
If successful, this could show that Acceptance and Commitment Therapy is more effective than standard behavioral therapy for helping people lose weight.
What could go wrong
This is a behavioral intervention, not a drug, so results may vary widely. Weight loss can be difficult to maintain, and the study's findings may not apply to everyone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

418 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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: * Overweight or obese (body mass index \[BMI\] \>= 27) but not heavier than BMI of 45.5 (measured by weight \& height) * Wants to lose weight in the next 30 days * Interested in learning skills to lose weight * Willing to be randomly assigned to either condition * Resides in United States (US) * Has daily access to their own phone and email * Does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder, and meeting criteria for severe depression (CESD \>= 25), or a diagnosis of serious heart disease, diabetes, uncontrolled hypertension, or cancer without written confirmation of approval from their physician office * Not pregnant, planning to become pregnant or breastfeeding in the next 12 months * In the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite * Have not lost more than 5% of their weight in the past 6 months * Willing and able to read in English * Not participating in or planning to participate in other weight loss programs * Has not participated in our other ACT intervention studies * Does not meet criteria for combined heavy plus binge drinking * Has access to a Bluetooth-enabled device and Wi-Fi and/or data plan * Is not planning to have or has not recently had (past 12 months) bariatric surgery * For outcome data retention, eligibility criteria included: Willing to complete follow-up surveys, and provide email, phone, and mailing address Exclusion Criteria: * The reverse of the inclusion criteria

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Conditions

The condition(s) this trial relates to.

cancer obesity disorder

As listed by the trial registrant

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

Obesity-related malignant neoplasm

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

More trials for these conditions

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