Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

Obesity-Related Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04447313
• Other study ID #: RG1007177
• Secondary ID: NCI-2020-0162410
• Status: Recruiting
• Phase: Phase 3
• Start date: March 5, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Brie Sullivan
• Phone: 206-667-5238
• Email: bsulliva[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 398
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Obesity-Related Malignant Neoplasm
• Weight Loss

Intervention

Other:
• Survey Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive ACT telephone coaching
• Telephone-Based Intervention
Receive SBT telephone coaching

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent weight change	Will be measured remotely by cellular-enabled scales.	At 6, 12, and 24-months post randomization
Secondary	Dietary intake	Will be measured with the Fitbit smartphone app food logging feature.	At 6, 12, and 24-months post randomization
Secondary	Physical activity	Will be measured with the Fitbit Inspire mailed to participants.	At 6, 12, and 24-months post randomization
Secondary	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