NCT04447313

Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

Telephone Delivered Weight Loss, Nutrition, Exercise Study (WeLNES)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

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. 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.

Conditions

• Obesity-Related Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Survey Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive ACT telephone coaching
BEHAVIORAL	Telephone-Based Intervention	Receive SBT telephone coaching

Timeline

• Start date: 2021-03-05
• Primary completion: 2025-11-09
• Completion: 2026-11-09
• First posted: 2020-06-25
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States