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Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

Primary Purpose

Obesity-Related Malignant Neoplasm

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Survey Administration

Telephone-Based Intervention

About this trial

This is an interventional prevention trial for Obesity-Related Malignant Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (ACT)

Arm II (SBT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

10% or more weight loss

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

Secondary Outcome Measures

Percent weight change

Will be measured remotely by cellular-enabled scales.

Dietary intake

Will be measured with the Fitbit smartphone app food logging feature.

Physical activity

Will be measured with the Fitbit Inspire mailed to participants.

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.

Full Information

NCT ID

NCT04447313

First Posted

June 23, 2020

Last Updated

August 31, 2023

Sponsor

Fred Hutchinson Cancer Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04447313

Brief Title

Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 5, 2021 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity-Related Malignant Neoplasm

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

398 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (ACT)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (SBT)

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Survey Administration

Intervention Description

Ancillary studies

Intervention Type

Behavioral

Intervention Name(s)

Telephone-Based Intervention

Intervention Description

Receive ACT telephone coaching

Intervention Type

Behavioral

Intervention Name(s)

Telephone-Based Intervention

Intervention Description

Receive SBT telephone coaching

Primary Outcome Measure Information:

Title

10% or more weight loss

Description

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

Time Frame

At 12 months after randomization

Secondary Outcome Measure Information:

Title

Percent weight change

Description

Will be measured remotely by cellular-enabled scales.

Time Frame

At 6, 12, and 24-months post randomization

Title

Dietary intake

Description

Will be measured with the Fitbit smartphone app food logging feature.

Time Frame

At 6, 12, and 24-months post randomization

Title

Physical activity

Description

Will be measured with the Fitbit Inspire mailed to participants.

Time Frame

At 6, 12, and 24-months post randomization

Title

Trajectories of weight change

Description

Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time.

Time Frame

At 6, 12, and 24-months post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Exclusion Criteria: The reverse of the inclusion criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brie Sullivan

Phone

206-667-5238

bsulliva@fredhutch.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan B Bricker

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brie Sullivan

Phone

206-667-5238

bsulliva@fredhutch.org

First Name & Middle Initial & Last Name & Degree

Jonathan B Bricker

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

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