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Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study

Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03738540
Acronym
WeLNES
Enrollment
105
Registered
2018-11-13
Start date
2018-08-29
Completion date
2020-12-31
Last updated
2021-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight, Body, Weight Loss

Keywords

Weight loss, Nutrition, Exercise, Diet, Telephone coaching

Brief 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 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.

Interventions

BEHAVIORALTALK study group

Telephone Delivered Intervention

BEHAVIORALTALK control group

Telephone Delivered Intervention

Sponsors

Fred Hutchinson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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, * 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.

Exclusion criteria

* Opposite of the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
12-month weight loss12 months post randomizationWeight 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.

Secondary

MeasureTime frameDescription
3-month weight loss3 months post randomizationWeight 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.
6-month weight loss6 months post randomizationWeight 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026