Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT04447313
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Seattle, Washington, 98109, United States
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.
Participants are followed up at 6, 12, and 24 months after randomization.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Receive ACT telephone coaching
Time frame: At 12 months after randomization
Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression.
Time frame: At 6, 12, and 24-months post randomization
Will be measured remotely by cellular-enabled scales.
Time frame: At 6, 12, and 24-months post randomization
Will be measured with the Fitbit smartphone app food logging feature.
Time frame: At 6, 12, and 24-months post randomization
Will be measured with the Fitbit Inspire mailed to participants.
Time frame: At 6, 12, and 24-months post randomization
Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time.
Fred Hutchinson Cancer Center
Other
Telephone Delivered Weight Loss, Nutrition, Exercise Study (WeLNES)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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