Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

NCT04447313 | Active Not Recruiting Phase 3

• 4 other identifiers: RG1007177NCI-2020-0162410404R01DK124114
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 10% or more weight loss

  Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression.

  At 12 months after randomization

Secondary Outcomes (4)

• Percent weight change

  At 6, 12, and 24-months post randomization

• Dietary intake

  At 6, 12, and 24-months post randomization

• Physical activity

  At 6, 12, and 24-months post randomization

• Trajectories of weight change

  At 6, 12, and 24-months post randomization

Study Arms (2)

Arm I (ACT)

EXPERIMENTAL

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.

Other: Survey Administration; Behavioral: Telephone-Based Intervention

Arm II (SBT)

ACTIVE COMPARATOR

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.

Other: Survey Administration; Behavioral: Telephone-Based Intervention

Interventions

Survey Administration OTHER

Ancillary studies

Arm I (ACT); Arm II (SBT)

Telephone-Based Intervention BEHAVIORAL

Receive ACT telephone coaching

Arm I (ACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Study Officials

• Jonathan B Bricker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: March 5, 2021
• Primary Completion: November 9, 2025
• Study Completion (Estimated): November 9, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)