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NCT Number: NCT04447313

Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive ACT telephone coaching

Primary outcomes

  1. 10% or more weight loss

    Time frame: At 12 months after randomization

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

Secondary outcomes

  1. Percent weight change

    Time frame: At 6, 12, and 24-months post randomization

    Will be measured remotely by cellular-enabled scales.

  2. Dietary intake

    Time frame: At 6, 12, and 24-months post randomization

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

  3. Physical activity

    Time frame: At 6, 12, and 24-months post randomization

    Will be measured with the Fitbit Inspire mailed to participants.

  4. Trajectories of weight change

    Time frame: At 6, 12, and 24-months post randomization

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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 25, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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