Weight LossWeLNESNCT03738540
Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study
A study testing TALK study group in people with Weight Loss and Weight, Body, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Weight, Body
- What is being tested?
- TALK study group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age 18 or older,
- overweight or obese (BMI ≥ 27),
- wants to lose weight through healthy behavior change, beginning in the next 30 days,
- interested in learning skills to lose weight,
- willing to be randomly assigned to either condition,
- resides in US,
Show all 15Show fewer
- 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,
- not pregnant or planning to become pregnant 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 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, and
- has not participated in our other ACT interventions. To increase follow-up data retention, eligibility criteria also include:
- willing to complete the follow-up survey, and (16) provide email, phone, and mailing address.
Who cannot join
- Opposite of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)
Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on proven success using ACT telephone counseling intervention for smoking cessation.
Read the detailed description
There is consistent evidence from observational studies that higher amounts of body fat are associated with increased risks of cancer. Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. However, this study required in-person clinic visits with treatment groups, which limits its potential reach and disseminability. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on our proven success using ACT telephone counseling intervention for smoking cessation. There will be a two-arm pilot randomized trial (N = 100), comparing the ACT telephone intervention to a standard behavioral treatment (SBT) telephone control. The pilot RCT will yield engagement, receptivity, and preliminary weight loss results that will provide critical and timely weight loss intervention data.
- Conditions
- Weight Loss, Weight, Body
- Being tested
- TALK study group, TALK control group
- Keywords
- Weight loss, Nutrition, Exercise, Diet, Telephone coaching
- Medical subject headings
- Weight Loss, Body Weight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TALK study groupBehavioural
Telephone Delivered Intervention
TALK control groupBehavioural
Telephone Delivered Intervention
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This is the experimental arm of the study. This includes 25 weekly then biweekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study. Receives: Behavioral: TALK study group |
| Control | Active comparator | This is the control arm of the study. This includes This includes 25 weekly then biweekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study. Receives: Behavioral: TALK control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month weight loss
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
Measured: 12 months post randomization
Secondary outcomes (2)
3-month weight loss
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
Measured: 3 months post randomization
6-month weight loss
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start29 Aug 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738540
- Sponsor's protocol ID
- 8693
- Other IDs
- NCI-2019-02521, RG1001915
- Acronym
- WeLNES
- Status last verified
- Jan 2021
- First submitted
- 2 Oct 2018
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bricker JB, Mull KE, Sullivan BM, Forman EM. Efficacy of telehealth acceptance and commitment therapy for weight loss: a pilot randomized clinical trial. Transl Behav Med. 2021 Aug 13;11(8):1527-1536. doi: 10.1093/tbm/ibab012.
PubMed 33787926
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)
- ClinicalTrials.gov ID
- NCT03738540
- Acronym / sponsor ID
- WeLNES / 8693
- Conditions
- Weight Loss, Weight, Body
- Keywords
- Weight loss, Nutrition, Exercise, Diet, Telephone coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on proven success using ACT telephone counseling intervention for smoking cessation.
Detailed description
There is consistent evidence from observational studies that higher amounts of body fat are associated with increased risks of cancer. Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. However, this study required in-person clinic visits with treatment groups, which limits its potential reach and disseminability. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on our proven success using ACT telephone counseling intervention for smoking cessation. There will be a two-arm pilot randomized trial (N = 100), comparing the ACT telephone intervention to a standard behavioral treatment (SBT) telephone control. The pilot RCT will yield engagement, receptivity, and preliminary weight loss results that will provide critical and timely weight loss intervention data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: TALK study groupThis is the experimental arm of the study. This includes 25 weekly then biweekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study. |
| Control | Active comparator | Behavioral: TALK control groupThis is the control arm of the study. This includes This includes 25 weekly then biweekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- age 18 or older,
- overweight or obese (BMI ≥ 27),
- wants to lose weight through healthy behavior change, beginning in the next 30 days,
- interested in learning skills to lose weight,
- willing to be randomly assigned to either condition,
Key exclusion criteria (1 listed)
- Opposite of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TALK study groupTelephone Delivered Intervention | Behavioural | Experimental |
| TALK control groupTelephone Delivered Intervention | Behavioural | Control |
Primary outcome
12-month weight loss
Time frame: 12 months post randomization
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
2 secondary outcomes
3-month weight loss
Time frame: 3 months post randomization
6-month weight loss
Time frame: 6 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Derived from this study: PubMed 33787926Bricker JB, Mull KE, Sullivan BM, Forman EM. Efficacy of telehealth acceptance and commitment therapy for weight loss: a pilot randomized clinical trial. Transl Behav Med. 2021 Aug 13;11(8):1527-1536. doi: 10.1093/tbm/ibab012.
- Study recruitment websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Bricker, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TALK study group in people with Weight Loss and Weight, Body, 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 15 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: finished, as of the sponsor's last update on 7 Jan 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
12-month weight loss (time frame: 12 months post 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 NCT03738540, which also lists 1 linked publication.
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 7 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.