NCT04447313Active, not recruitingPhase 3
Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study
Telephone Delivered Weight Loss, Nutrition, Exercise Study (WeLNES)
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
This phase III trial compares telephone delivered Acceptance and Commitment Therapy to standard behavioral therapy for improving weight loss in overweight or obese participants. Acceptance and Commitment Therapy focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. Acceptance and Commitment Therapy may work better at improving weight loss compared to standard behavioral therapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (actual)
- First submitted
- 23 Jun 2020
- Start date
- 5 Mar 2021
- Primary completion date
- 9 Nov 2025
- Lead sponsor
- Fred Hutchinson Cancer Center
- Diseases
- Obesity
- NCT number
- NCT04447313
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 418
- From 5 Mar 2021 to the primary completion date, 9 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- The reverse of the inclusion criteria
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.