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Behavioural Intervention

Behavioral Therapies for Weight Loss

Phase 3
Recruiting
Led By Jonathan B Bricker
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have not lost more than 5% of their weight in the past 6 months
In the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, and 24-months post randomization
Awards & highlights

Study Summary

This trial compares two treatments for weight loss in overweight or obese people. One treatment is standard behavioral therapy, and the other is called Acceptance and Commitment Therapy. Acceptance and Commitment Therapy focuses on being willing to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. This trial will see if Acceptance and Commitment Therapy is better at improving weight loss compared to standard behavioral therapy.

Who is the study for?
This trial is for US residents who are overweight or obese (BMI >= 27 but <= 45.5), not pregnant, and without certain medical conditions like severe heart disease, uncontrolled hypertension, or cancer. Participants must be willing to try a new weight loss therapy over the phone, have daily access to a phone and email, can read English, aren't on other weight loss programs or studies, and haven't had significant weight changes recently.Check my eligibility
What is being tested?
The study tests if Acceptance and Commitment Therapy delivered by telephone helps with weight loss better than standard behavioral therapy. It involves accepting cravings while making committed changes aligned with personal values. Participants will be randomly assigned to one of these two approaches.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on behavior change through telephone counseling rather than medication or surgery, there may not be direct side effects; however participants might experience emotional discomfort as they work through their behaviors related to eating and weight.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not lost more than 5% of my weight in the last 6 months.
Select...
I haven't changed my medication dosage in the last 3 months that affects my weight or appetite.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 12, and 24-months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, and 24-months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
10% or more weight loss
Secondary outcome measures
Dietary intake
Percent weight change
Physical activity
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ACT)Experimental Treatment2 Interventions
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 II: Arm II (SBT)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2017
Completed Phase 2
~3400

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,937 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,080 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,365 Previous Clinical Trials
4,315,804 Total Patients Enrolled

Media Library

Cancer Research Study Groups: Arm II (SBT), Arm I (ACT)
Cancer Clinical Trial 2023: Telephone-Based Intervention Highlights & Side Effects. Trial Name: NCT04447313 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Survey Administration process in line with FDA regulations?

"Survey Administration has been studied in a Phase 3 trial, so there is some data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
What site did they apply to?
Fred Hutch/University of Washington Cancer Consortium
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study
2021. "Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04447313.
~101 spots leftby Jun 2025
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