Status:
ACTIVE_NOT_RECRUITING
Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity-Related Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Commitm...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- The reverse of the inclusion criteria
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2026
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT04447313
Start Date
March 5 2021
End Date
November 9 2026
Last Update
November 24 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109