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Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

StatusActive, Not Recruiting
PhasePhase 3
Started2021-03-05
View on ClinicalTrials.gov ↗

Amendment history

2025-11-21
2 amendments v14-v15
2 re-verifications since 2025-08-19, no change to tracked fields
2025-02-18
Study Status v13
Primary completion date2025-11-10→2025-11-09
Completion date2026-11-10→2026-11-09
2024-08-15
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations, Document Section v12
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-06-30→2025-11-10
Completion date2026-06-30→2026-11-10
Enrollment targetestimated 398→confirmed 418
Study sitesdetails revised at 1 of 1 site
2024-02-15
3 amendments v9-v11
3 re-verifications since 2023-02-22, no change to tracked fields
2022-08-12
Study Status v8
Primary completion date2024-06-30→2025-06-30
Completion date2025-06-30→2026-06-30
Show 7 earlier versions
2022-02-28
Study Identification, Study Status, Sponsor/Collaborators, Eligibility v7
Eligibility criteria+158 characters
[...] der, 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 [...]
Collaborators2 to 1 entries
National Cancer Institute (NCI)
2021-08-31
Study Identification, Study Status, Outcome Measures, Eligibility v6
Eligibility criteria+187 characters
[...] t loss, including meeting criteria for binge eating disorder, and meeting criteria for severe depression (CESD >= 25) Not pregnant, planning to become pregnant or breastfeeding [...] 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 mon [...]
Secondary endpointsdetails revised at 2 of 4 entries
Study title-18 characters
Telephone Delivered Acceptance and Commitment Therapy for Weight Loss, Nutrition, Exercise WeLNES Study
2021-05-14
Study Status v5
Start date2021-03-08→2021-03-05
2021-03-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-03-05→confirmed 2021-03-08
Study sitesdetails revised at 1 of 1 site
2021-02-05
Study Status v3
Start date2021-02-04→2021-03-05
2021-01-04
Study Status v2
Start date2021-01-02→2021-02-04
2020-08-19
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2020-06-23
Original filing
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.
Trial Details
NCT Number NCT04447313
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Obesity-Related Malignant Neoplasm
Enrollment 418 participants
Start Date 2021-03-05
Primary Completion 2025-11-09 (estimated)
Study Completion 2026-11-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-24