Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

NCT ID: NCT04447313

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2026-11-09

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I (ACT)

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.

Group Type: EXPERIMENTAL

Survey Administration

Intervention Type: OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Receive ACT telephone coaching

Arm II (SBT)

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.

Group Type: ACTIVE_COMPARATOR

Survey Administration

Intervention Type: OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Receive SBT telephone coaching

Interventions

Survey Administration

Ancillary studies

Intervention Type: OTHER

Telephone-Based Intervention

Receive ACT telephone coaching

Intervention Type: BEHAVIORAL

Telephone-Based Intervention

Receive SBT telephone coaching

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan B Bricker

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2020-01624

Identifier Type: REGISTRY

Identifier Source: secondary_id

10404

Identifier Type: OTHER

Identifier Source: secondary_id

R01DK124114

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1007177

Identifier Type: -

Identifier Source: org_study_id