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Obesity-Related Malignant NeoplasmPhase 3NCT04447313

Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

A Phase 3 study testing Survey Administration and Telephone-Based Intervention in people with Obesity-Related Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity-Related Malignant Neoplasm
What is being tested?
Survey Administration and Telephone-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
1 siteUnited States
Study dates
5 Mar 2021to 9 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • The reverse of the inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Telephone Delivered Weight Loss, Nutrition, Exercise Study (WeLNES)

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.

Read the 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.

Being tested
Survey Administration, Telephone-Based Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Survey AdministrationOther

    Ancillary studies

  • Telephone-Based InterventionBehavioural

    Receive ACT telephone coaching

  • Telephone-Based InterventionBehavioural

    Receive SBT telephone coaching

Study groups in NCT04447313
Study groupRoleWhat they receive
Arm I (ACT)ExperimentalParticipants 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.
Receives: Other: Survey Administration; Behavioral: Telephone-Based Intervention
Arm II (SBT)Active comparatorParticipants 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.
Receives: Other: Survey Administration; Behavioral: Telephone-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10% or more weight loss

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

    Measured: At 12 months after randomization

Secondary outcomes (4)

  1. Percent weight change

    Will be measured remotely by cellular-enabled scales.

    Measured: At 6, 12, and 24-months post randomization

  2. Dietary intake

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

    Measured: At 6, 12, and 24-months post randomization

  3. Physical activity

    Will be measured with the Fitbit Inspire mailed to participants.

    Measured: At 6, 12, and 24-months post randomization

  4. 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.

    Measured: At 6, 12, and 24-months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start5 Mar 2021
  3. Primary completion9 Nov 2025
  4. Study completion9 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447313
Sponsor's protocol ID
RG1007177
Other IDs
NCI-2020-01624, 10404, R01DK124114
Status last verified
Nov 2025
First submitted
23 Jun 2020
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Survey Administration and Telephone-Based Intervention in people with Obesity-Related Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10% or more weight loss (time frame: At 12 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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