Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity-Related Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration; Behavioral: Telephone-Based Intervention; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 398
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Brie Sullivan; Phone Number: 206-667-5238; Email: bsulliva@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Jonathan B Bricker
      • Contact: Brie Sullivan; Phone Number: 206-667-5238; Email: bsulliva@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• The reverse of the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive ACT telephone coaching; Behavioral: Telephone-Based Intervention; Receive SBT telephone coaching
Active Comparator: 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.	Other: Survey Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive ACT telephone coaching; Behavioral: Telephone-Based Intervention; Receive SBT telephone coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent weight change	Will be measured remotely by cellular-enabled scales.	At 6, 12, and 24-months post randomization
Dietary intake	Will be measured with the Fitbit smartphone app food logging feature.	At 6, 12, and 24-months post randomization
Physical activity	Will be measured with the Fitbit Inspire mailed to participants.	At 6, 12, and 24-months post randomization
Trajectories of weight change	Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time.	At 6, 12, and 24-months post randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jonathan B Bricker, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Neoplasms; Weight Loss
• Other Study ID Numbers: RG1007177; 10404 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2020-01624 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01DK124114 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No