Clinical trial

Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT04447313

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionObesity-Related Malignant Neoplasm

Full registry 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

Treatments and study arms

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive ACT telephone coaching

Telephone-Based Intervention

Behavioral

Receive SBT telephone coaching

Primary outcomes

10% or more weight lossAt 12 months after randomization

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Fred Hutch/University of Washington Cancer Consortium🇺🇸 Seattle, Washington, United States